this cpb has been revised to state that spect is …...single photon emission computed tomography...

Prior Authorization ReviewPanel MCO Policy Submission

A separate copy of this form must accompany each policy submitted for review.

Policies submitted without this form will not be considered for review.

Plan: Aetna Better Health Submission Date: 09/04/2018

Policy Number: 0376 Effective Date: Revision Date: 08/01/2018

Policy Name: Single Photon Emission Computed Tomography (SPECT)

Type of Submission – Check all that apply: New Policy Revised Policy* Annual Review – No Revisions

*All revisions to the policy must be highlighted using track changes throughout the document. Please provide any clarifying information for the policy below:

CPB 376 Single Photon Emission Computed Tomography (SPECT)

06/14/2018 - This CPB has been revised to state that SPECT is considered experimental and investigational for the following: (i) evaluation of carotid stenosis, (ii) as an imaging marker of pre- diagnostic Parkinson's disease, and (iii) work-up of individuals undergoing non-cardiac surgery. 08/01/2018.- This CPB is revised to state that SPECT is considered medically necessary for the diagnosis of coronary artery disease and for the assessment of prognosis in persons with coronary artery disease except as outlined in exclusion criteria.

Name of Authorized Individual (Please type or print):

Dr. Bernard Lewin, M.D.

Signature of Authorized Individual:

www.aetnabetterhealth.com/pennsylvania Revised 08/01/2018

http://www.aetnabetterhealth.com/pennsylvania

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Single Photon Emission Computed Tomography (SPECT) - Medical Clinical Policy Bulle...

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(https://www.aetna.com/)

Single Photon EmissionComputed Tomography (SPECT)

Clinical Policy Bulletins Medical Clinical Policy Bulletins

Polic y His t ory

Last Review

08/01/2018

Effective: 03/08/200

Next

Review: 04/11/2019

Review

History

Definitions

A ddit iona l Inform at ion

Number: 0376

*Please see amendment for Pennsylvania Medicaid at the end of this CPB.

Policy

I. Non-Cardiac Indications: Aetna considers single photon emission computed

tomography (SPECT) medically necessary for any of the following indications:

A. Assessment of osteomyelitis, to distinguish bone from soft tissue infection;

or

B. Detection of spondylolysis and stress fractures not visible from x-ray; or

C. Diagnosing and assessing hemangiomas of the liver; or

D. Diagnosing pulmonary embolism (by means of SPECT ventilation/perfusion

scintigraphy); or

E. Differentiation of necrotic tissue from tumor of the brain; or

F. Distinguishing Parkinson's disease from essential tremor (e.g., DaTSCAN

(Ioflupane I-123 injection); or

G. Imaging of parathyroids in parathyroid disease; or

H. Localization of abscess, for suspected or known localized infection or

inflammatory process; or

I. Lymphoma, to distinguish tumor from necrosis; or

J. Neuroendocrine tumors, diagnosis and staging; or

09/03/2018

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https://www.aetna.com/

Single Photon Emission Computed Tomography (SPECT) - Medical Clinical Policy Bulle... Page 2 of 44

K. Pre-surgical ictal detection of seizure focus in members with epilepsy (in

place of positron emission tomography (PET)).

II. Aetna considers SPECT experimental and investigational for all other non-

cardiac indications, including any of the following, because its diagnostic

value has not been established in the peer-reviewed medical literature in

these situations:

A. As an imaging marker of pre-diagnostic Parkinson's disease; or

B. Detection of air leak/pneumothorax; or

C. Diagnosis or assessment of members with attention deficit/hyperactivity

disorder (

CPB 0426 - Attention Deficit/Hyperactivity Disorder

(../400_499/0426.html) );

or

D. Diagnosis or assessment of members with autism (

CPB 0648 - Autism Spectrum Disorders (../600_699/0648.html)); or

E. Diagnosis or assessment of members with personality disorders (e.g.,

aggressive and violent behaviors, anti-social personality disorder including

psychopathy, schizotypal personality disorder, as well as borderline

personality disorder); or

F. Diagnosis or assessment of members with schizophrenia; or

G. Diagnosis or assessment of stroke members; or

H. Differential diagnosis of Parkinson's disease from other Parkinsonian

syndromes; or

I. Differentiating malignant from benign lung lesions; or

J. Evaluation of carotid stenosis; or

K. Evaluation of members with endoleak; or

L. Evaluation of members with generalized pain or insomnia; or

M. Evaluation of members with head trauma; or

N. Initial or differential diagnosis of members with suspected dementia (e.g.,

Alzheimer's disease, dementia with Lewy bodies, frontotemporal dementia,

and vascular dementia); or

O. Multiple sclerosis; or

P. Pre-surgical evaluation of members undergoing lung volume reduction

surgery; or

Q. Prosthetic graft infection; or

http://qawww.aetna.com/cpb/medical/data/300_399/0376_draft.html 09/03/2018



R. Scanning of internal carotid artery during temporary balloon occlusion; or

S. Vasculitis; or

T. Work-up of individuals undergoing non-cardiac surgery.

III. Cardiac Indications: Aetna considers SPECT medically necessary for the

diagnosis of coronary artery disease and for the assessment of prognosis in

persons with coronary artery disease except as outlined in "exclusion

criteria" below."

IV. Aetna considers SPECT experimental and investigational for all other cardiac

indications because its effectiveness for indications other than the ones

listed above has not been established.

Exclusion criteria: Aetna considers SPECT myocardial perfusion imaging

experimental and investigational for the following indications for which the

study is considered “inappropriate” according to appropriateness

criteria from the American College of Cardiology (ACC):

A. As a routine screening evaluation after a percutaneous transluminal

coronary angioplasty (PTCA) with or without stenting or coronary artery

bypass surgery (CABG) prior to discharge from the acute care setting; or

B. As a routine screening evaluation after a re-vascularization procedure

(PTCA with stenting or CABG) at an interval of less than 2 years from the

procedure if there is no worsening in the members symptomatology and if

the member had symptoms prior to the intervention, and there is no history

of congestive heart failure. Note: If there is a history of congestive heart

failure and the member is status post re-vascularization, repeat nuclear

imaging as frequently as annually may be medically necessary; or

C. Assessment of vulnerable plaque; or

D. Evaluation of a member with an acute coronary event and hemodynamic

instability, shock, or mechanical complications of the event; or




E. In the setting of acute chest pain or equivalent symptoms with a high

likelihood of being acute coronary syndrome, when there has been a

diagnosis of acute myocardial infarction, in the immediate post-thombolytic

period, or when there is a high pre-test likelihood of significant coronary

disease as demonstrated by marked ST segment elevation on the ECG; or

F. Prior to high-risk+ surgery when the member is asymptomatic and there was

a normal cardiac catheterization, coronary intervention (PTCA, stenting,

CABG), or normal nuclear stress test less than 1 year before the surgical

date; or

G. Prior to intermediate-risk+ non-cardiac surgery if the member is capable of,

and has no contraindication to standard stress testing*; or

H. Prior to low-risk+ non-cardiac surgery for risk assessment; or

I. Re-evaluation of members without chest pain or equivalent symptoms,

without known coronary disease, at high-risk for coronary disease (based

upon the Framingham score greater than 10)*, who have an initial negative

radionuclear imaging study, when it has been less than 2 years since the

last radionuclear study; or

J. Re-evaluation of members without chest pain or equivalent symptoms or

with stable symptoms, with known coronary disease as determined by prior

abnormal catheterization or SPECT cardiac study (but without prior

infarction), when it has been less than 1 year since the last radionuclear

study. Note: if the member has worsening symptoms or if the member had

silent ischemia, more frequent imaging or other diagnostic testing or

interventions may be medically necessary; or

K. Screening of members with chest pain or chest pain equivalent symptoms

when there is a low probability of coronary disease (Framingham score less

than 10)*, no history of diabetes, and there are no impediments or

contraindications to non-nuclear stress testing*; or

L. Screening of members without chest pain or equivalent symptoms when

there is a low probability of coronary disease (Framingham score less

than 10)* and no history of diabetes; or




* A tool for calculating Framingham score is available from the National

Heart Lung and Blood Institute at the following website:

Framingham Score from National Heart Lung and Blood

Institute (http://cvdrisk.nhlbi.nih.gov/)

.

* According to ACC guidelines, the following are impediments or

contraindications to non-nuclear stress testing:

A. A history of physical impairments that would preclude physically performing

the exercise portion of a stress test; or

B. A history of prior proven ischemic cardiac events; or

C. Proven CAD by past SPECT or coronary catheterization; or

D. The member's ECG would prevent interpretation of a standard stress

testing by being “uninterpretable” during the test, i.e., left bundle branch

block (LBBB), paced rhythm, Wolf Parkinson White syndrome, left

ventricular hypertrophy (LVH) with ST segment depression, or digoxin

use.

+ Surgical risk categories.

▪ High-risk surgery (risk of cardiac death or myocardial infarction (MI) greater

than 5 %): emergent major operations (particularly in the elderly), aortic and

peripheral vascular surgery, prolonged surgical procedures associated with

large fluid shifts and/or blood loss.

▪ Intermediate-risk surgery (risk of cardiac death or MI 1 % to 5 %): carotid

endarterectomy, head and neck surgery, surgery of the chest or abdomen,

orthopedic surgery, prostate surgery.

▪ Low-risk surgery (cardiac death or MI less than 1 %): endoscopic

procedures, superficial procedures, cataract surgery, breast surgery.

V. Aetna considers myocardial sympathetic innervation imaging, with or

without SPECT, experimental and investigational because its effectiveness

has not been established.



http://cvdrisk.nhlbi.nih.gov/


VI. Aetna considers SPECT-CT fusion medically necessary for parathyroid

imaging in persons with an enlarged parathyroid gland, parathyroid

hyperplasia or suspected parathyroid adenoma or carcinoma,

and laboratory evidence of hyperparathyroidism (parathyroid hormone

greater than 55 pg/ml and serum calcium greater than 10.2 mg/dL).

Aetna considers SPECT-CT fusion imaging as experimental and

investigational for other indications because of insufficient evidence of its

effectiveness.

VII. Aetna considers freehand SPECT/ultrasonography (US) fusion imaging in

persons with thyroid disease experimental and investigational because of

insufficient evidence of itseffectiveness.

B ac kgro und

Single photon emission computed tomography (SPECT) is a nuclear medicine

technique that uses radiopharmaceuticals, a rotating camera (single or multiple-

head), and a computer to produce images representing slices through the body in

different planes. Single photon emission computed tomography images are

functional in nature rather than being purely anatomical such as ultrasound,

computed tomography (CT), and magnetic resonance imaging (MRI).

SPECT for Myocardial Perfusion Imaging

Single photon emission computed tomography has been applied to the heart for

myocardial perfusion imaging. It is an effective non-invasive diagnostic technology

when evaluating patients for clinically significant coronary artery disease (CAD) in

the following circumstances: for diagnosing CAD in patients with an abnormal

resting electrocardiogram (ECG) and restricted exercise tolerance; or assessing

myocardial viability before referral for myocardial re-vascularization.

Single photon emission computed tomography has a far greater sensitivity for

detecting silent ischemia than stress ECG. Pooled data of exercise SPECT studies

in over 1,000 patients revealed a 90 % overall sensitivity for detecting CAD. In

assessing myocardial viability, studies indicate that, even in patients with severe




irreversible thallium defects on standard exercise-redistribution imaging, thallium re-

injection provides information regarding myocardial viability that is comparable to

that provided by positron emission tomography (PET).

SPECT for Detection of Neurological Diseases

Single photon emission computed tomography examines cerebral function by

documenting regional blood flow and metabolism; SPECT of the brain is a useful

alternative to PET for the pre-surgical ictal detection of seizure focus. Effective

surgical treatment of patients with intractable epilepsy is dependent on accurate

localization of the epileptic focus and precise delineation of the epileptogenic

region. It is generally agreed that this requires EEG recording with

electrocorticography. This testing is designed to identify the source or sources of

the seizures, as well as an assessment of brain function. The search for non-

invasive and cost-effective means of seizure localization has been an important

area of research.

Seizures are associated with dramatic increases in blood flow, localized in partial

seizures and global during generalized seizures. Ictal SPECT uses the physiologic

increase in regional cerebral blood blow during seizures to potentially localize the

epileptogenic region. Ictal studies, although more difficult logistically, are reported

to have a sensitivity of 81 to 93 %. (Interictal SPECT demonstrates hypo-perfusion

and is reported to have a sensitivity ranging from 40 to 75 %).

Other imaging modalities help in localizing abnormal epileptogenic tissue.

Quantitative MRI has a sensitivity of 80 to 90 % for the lateralization of temporal

lobe epilepsy. However, there are instances where ictal SPECT has identified

lesions not detected by MRI. Depth electrocorticography and intra-operative

electrocorticography, though accurate in many forms of epilepsy, are both highly

invasive. In cortical developmental disorders, these EEG techniques often fail to

localize the epileptogenic area. Single photon emission computed tomography

imaging may offer a safe and accurate alternative.

Ictal SPECT testing requires that seizure activity be provoked through reduction of

anti-epileptic medications. Video EEG monitoring may also be performed. Due to

the nature of ictal SPECT, it should be performed in a hospital setting.




Studies of SPECT in the inter-ictal or post-ictal detection of seizure focus,

determination of seizure subtypes and monitoring of drug therapy for epilepsy have

not established its efficacy for these indications.

Clinical studies indicate that SPECT is more accurate at detecting acute ischemia

than CT scan. By 8 hours after infarction, about 20 % of CT scans will be positive

but nearly 90 % of SPECT scans will be. Beyond 72 hours, the sensitivities of CT

and SPECT are nearly identical. In addition, the defects noted on SPECT are

frequently larger than those noted on CT studies.

Among the treatments of acute ischemic stroke, the use of tissue plasminogen

activator (t-PA) has been shown to reduce neurologic impairment if administered

within 3 hours of onset. This is administered when CT is negative for hemorrhage.

Single photon emission computed tomography can not detect hemorrhage in order

to rule out use of thrombolysis. Therefore, while SPECT is more sensitive than CT

in detecting ischemia, it has not been shown to be useful in detecting ischemia

early enough to play a role in the use of thrombolysis. Studies using SPECT in the

presence of cerebro-vascular accident (CVA) have timed its performance at less

than 6 hours to less than 14 days from the time of onset.

Studies have also reported on SPECT's value with regard to the assessment of

prognosis after stroke, determination of stroke type, monitoring therapies used

post-stroke, diagnosis of vasospasm following subarachnoid hemorrhage and in the

diagnosis/prognosis regarding transient ischemic attacks (TIAs). Single photon

emission computed tomography may prove to be helpful in these applications in the

future.

Single photon emission computed tomography has proven useful in distinguishing

recurrent brain tumor from radiation necrosis. Radiation necrosis needs to be

distinguished from recurrent brain tumor to determine whether chemotherapy is

necessary. Radiation necrosis is more common in brain tumor patients receiving

local boost irradiation. Radiation necrosis and brain tumor may have similar clinical

signs and symptoms, and are not reliably distinguished clinically.

Single photon emission computed tomography has been studied in the diagnosis of

patients with Alzheimer's disease AD). At present, the definitive diagnosis of AD

can only be made on pathologic examination of brain tissue. Alzheimer's disease is

largely a diagnosis of exclusion. The diagnostic evaluation of the demented patient




is therefore aimed largely at identifying other potentially treatable causes of

cognitive impairment. A technology assessment of SPECT for dementia and AD

prepared by the Institute for Clinical Effectiveness and Health Policy (Ferrante,

2004) concluded: "SPECT has not clearly demonstrated its usefulness in assessing

patients with dementia, and it has no precise indications for diagnosis, evaluation of

prognosis or monitoring response to treatment."

In AD, SPECT shows decreased perfusion in the association cortex of the parietal

lobe and the posterior temporal regions. Frontal association cortex is

predominantly affected in some cases, but usually is not involved until late in the

course of the disease. The occipital lobes are less involved and the paracentral

cortex is spared. Although SPECT studies have been reported in over 500 patients

with AD, in most cases the diagnosis was made clinically and only in 53 patients it

was confirmed by autopsy. Controlled studies of SPECT in AD have shown a

sensitivity of this procedure to vary from 50 % to 95 %. The best results have been

reported in the more recent studies, using higher resolution equipment. In the 2001

practice parameter on the diagnosis of dementia, the American Academy of

Neurology does not recommend SPECT for routine use in either initial or differential

diagnosis of dementia (Knopman et al, 2001).

Neuroimaging markers are increasingly important in the early diagnosis of the

dementias, not only to detect the rare tumor, but also to differentiate the various

types of neurodegenerative dementias. The potential of MRI and PET as

surrogates for disease progression for therapeutic trials is being examined in a

large multi-center trial. However, SPECT has been reported to show specific

findings in both fronto-temporal dementia (FTD) and AD and is much more

available and less expensive than PET. McNeil et al (2007) evaluated the

diagnostic accuracy of technetium-99–labeled hexamethyl propylene amine oxime

SPECT images obtained at initial evaluation in 25 pathologically confirmed cases of

FTD and 31 pathologically confirmed cases of AD. A nuclear medicine physician,

blinded to the clinical findings, rated the images. Except in the case of 1 FTD

patient, for whom neuropsychological data were unavailable, the clinical and

neuropsychological evaluation was more accurate than SPECT alone in predicting

the histological diagnosis.

In a longitudinal, prospective study, Devanand and colleagues (2010) examined the

utility of SPECT to predict conversion from mild cognitive impairment (MCI) to AD.

A total of 127 patients with MCI and 59 healthy comparison subjects followed-up for




Single Photon Emission Computed Tomography (SPECT) - Medical Clinical Policy Bu... Page 10 of 44

1 to 9 years were included in this study. Diagnostic evaluation, neuropsychological

tests, social/cognitive function, olfactory identification, apolipoprotein E genotype,

MRI, and brain Tc hexamethyl-propylene-aminoxime SPECT scan with visual

ratings, and region of interest (ROI) analyses were done. Visual ratings of SPECT

temporal and parietal blood flow did not distinguish eventual MCI converters to AD

(n = 31) from non-converters (n = 96), but the global rating predicted conversion

(41.9 % sensitivity and 82.3 % specificity, Fisher's exact test p = 0.013). Blood flow

in each ROI was not predictive, but when dichotomized at the median value of the

patients with MCI, low flow increased the hazard of conversion to AD for parietal

(hazard ratio [HR]: 2.96, 95 % confidence interval [CI]: 1.16 to 7.53, p = 0.023) and

medial temporal regions (HR: 3.12, 95 % CI: 1.14 to 8.56, p = 0.027). In the 3-year

follow-up sample, low parietal (p < 0.05) and medial temporal (p < 0.01) flow

predicted conversion to AD, with or without controlling for age, Mini-Mental State

Examination, and apolipoprotein E ε4 genotype. These measures lost significance

when other strong predictors were included in logistic regression analyses: verbal

memory, social/cognitive functioning, olfactory identification deficits, hippocampal,

and entorhinal cortex volumes. The authors concluded that SPECT visual ratings

showed limited utility in predicting MCI conversion to AD. The modest predictive

utility of quantified low parietal and medial temporal flow using SPECT may

decrease when other stronger predictors are available.

Single photon emission computed tomography has also been reported to be used

in neoplasms (grading of gliomas), HIV encephalopathy, head trauma, Huntington's

chorea, persistent vegetative states and in diagnosing brain death. Based upon the

current evidence, SPECT has not proven to be established in any of these clinical

situations. More study is needed in these areas.

The Food and Drug Administration (FDA) has approved 4 radiopharmaceuticals for

imaging of the brain: I-123 isopropyliodoamphetamine (IMP, Spectamine); Tc-99m

HMPAO (hexamethyl propylamine oxime, Ceretec); Tc-99m ECD (ethyl cysteinate

dimer, Neurolite), and thallium 201 diethyldithiocarbamate (T1-DDC).

SPECT for the Liver

Hemangiomas are the most common benign lesion of the liver. It is important to

differentiate these lesions from others that may be malignant. Because of the risk

of hemorrhage inherent in a percutaneous biopsy of liver hemangiomas, non-

invasive modalities have been used for differentiation. Hepatic hemangiomas are

8



so vascular that their blood pool is easily differentiated from other solid hepatic

masses by nuclear scanning with labeled red blood cells (RBCs). The labeled

RBCs are injected intravenously and resolution is markedly improved with SPECT.

Review articles and published studies support SPECT as an appropriate diagnostic

modality to differentiate hepatic lesions as hemangiomas.

SPECT for Neuroendocrine Tumors

Carcinoids and other neuroendocrine tumors have somatostatin receptors;

therefore, they can be imaged with somatostatin analogs (octreotide, pentetreotide)

tagged with an appropriate radioisotope (Khan and Jones, 2005). Single photon

emission computed tomography and subtraction techniques improve detection. An

assessment from the Australian Medical Services Advisory Committee stated that

SPECT is often performed in conjunction with antibody imaging (Octreoscan) of

neuroendocrine tumors, usually at 24 and occasionally at 48 hours after the

injection. The assessment explained that SPECT is able to differentiate more

easily between areas of pathological uptake and physiological uptake in the

abdomen. The assessment explained that SPECT can also help to discriminate

between mesenteric and bone lesions. The assessment noted that extra-planar

images may be obtained from areas of specific interest, using longer exposure time

for more easily interpreted imaging.

SPECT for Spondylolysis and Stress Fractures

The role of SPECT of the spine has changed in recent years with the wide

availability of MRI and especially contrast-enhanced MRI. Bone scanning with

SPECT of the spine may allow for visualization of lesions related to stress fractures

or stress reactions in the spine such as spondylolysis. Single photon emission

computed tomography has been accepted as extremely sensitive in detecting

incipient spondylolysis and stress/insufficiency fractures (Manaster et al, 2005).

Single photon emission computed tomography shows stress fractures days to

weeks earlier than radiographs in many instances, and differentiate between

osseous and soft tissue injury as well. However, in most cases bone scans lack

specificity and supplemental imaging may be necessary for conclusive diagnosis or

to avoid false positives. Single photon emission computed tomography continues

to be used in back pain, especially in children and adolescents, to detect incipient

spondylolysis that may not be detected by conventional imaging. Because of the




sensitivity of SPECT scans, 80 % of all fractures show an abnormality 24 hours

post injury and 95 % at 72 hours. A normal scan generally excludes the diagnosis

of stress/insufficiency fracture, and the patient may return to normal activity.

SPECT for the Internal Carotid Artery

Internal carotid artery temporary balloon occlusion (TBO) test is a well-established

part of the preoperative evaluation of patients with aneurysm or tumor involving the

neck or skull base in whom arterial sacrifice or prolonged temporary occlusion is

considered a possible part of the surgical or endovascular therapy. Temporary

balloon occlusion is performed in conjunction with cerebral blood flow analysis to

identify those patients who will not tolerate permanent carotid occlusion.

Traditionally, xenon-enhanced CT has been used during TBO to detect signs of

ischemia; however, SPECT has recently been reported as a method to detect focal

hypo-perfusion during test occlusion. Several small studies in the published

literature report preliminary results that SPECT scanning during TBO is a safe and

effective method to assess cerebral blood flow. However, it is premature to

recommend SPECT over the conventional xenon-enhanced CT.

SPECT for the Diagnosis/Assessment of Attention Deficit/Hyperactivity Disorder

Functional neuroimaging such as PET and SPECT has been used to study patients

with attention deficit/hyperactivity disorder (ADHD). Although some studies have

shown differences in brain structure or function comparing children with and without

ADHD, these findings do not differentiate reliably between children with and without

this disorder (i.e., although group means may differ significantly, the overlap in

findings among children with and without ADHD results in high rates of false-

positives and false-negatives). As a result, SPECT should not be used as a

screening or diagnostic tool for children with ADHD. The American Academy of

Pediatrics' Practice Guideline on “Diagnosis and Evaluation of the Child with

Attention-Deficit/Hyperactivity Disorder” does not recommend neuroimaging studies

in the diagnosis of ADHD. An evidence review by McGough and Barkley (2004)

stated that there are insufficient scientific data to justify use of laboratory

assessment measures, including neuropsychological tests and brain imaging, in

diagnosing adult ADHD.

SPECT for the Diagnosis/Assessment of Autism




The American Academy of Neurology (2000) stated that there is no evidence to

support a role of neuroimaging modalities such as SPECT in the clinical diagnosis

of autism.

SPECT for the Diagnosis of Pulmonary Embolism

In a prospective, observational study, Miles and colleagues (2009) compared

SPECT ventilation/perfusion (V/P) scintigraphy with multi-slice CT pulmonary

angiography (CTPA) in the diagnosis of pulmonary embolism (PE). A total of 100

patients who were 50 years of age or older were recruited; 79 underwent both

diagnostic 16-detector CTPA, and planar and SPECT V/P scintigraphy. The

agreement between the CTPA and the SPECT V/P scintigraphy for the diagnosis of

PE was calculated. The sensitivity and specificity of blinded SPECT scintigraphy

reporting was calculated against a reference diagnosis made by a panel of

respiratory physicians that was provided with CTPA and planar V/P scintigraphy

reports, clinical information, and 3-month follow-up data. The observed percentage

of agreement between SPECT V/P scintigraphy and CTPA data for the diagnosis of

PE was 95 %. When calculated against the respiratory physicians' reference

diagnosis, SPECT V/P scintigraphy had a sensitivity of 83 % and a specificity of 98

%. The authors concluded that these findings indicated that SPECT V/P

scintigraphy is a viable alternative to CTPA for the diagnosis of PE and has

potential advantages in that it was feasible in more patients and had fewer

contraindications; lower radiation dose; and, arguably, fewer non-diagnostic

findings than CTPA.

Gutte et al (2010) evaluated the diagnostic performance of 3-dimensional V/P

SPECT in comparison with planar V/P scintigraphy. Consecutive patients

suspected of acute PE were referred to a V/P SPECT, as the first-line imaging

procedure. Patients with positive D-dimer (greater than 0.5 mg/L) or after clinical

assessment with a Wells score of more than 2 were included and had a V/P

SPECT, low-dose CT, planar V/P scintigraphy, and pulmonary multi-detector CTPA

performed the same day. Ventilation studies were performed using Krypton (Kr).

Patient follow-up was at least 6 months. A total of 36 patient studies were

available for analysis, of which 11 (31 %) had PE. V/P SPECT had a sensitivity of

100 % and a specificity of 87 %. Planar V/P scintigraphy had a sensitivity of 64 %

and a specificity of 72 %. The authors concluded that V/P SPECT has a superior

diagnostic performance compared with planar V/P scintigraphy and should be

preferred when diagnosing PE.





The European Association of Nuclear Medicine (EANM)'s practice guidelines on

ventilation/perfusion scintigraphy (Bajc et al, 2009a) stated that PE can only be

diagnosed with imaging techniques, which in practice is performed using V/P

scintigraphy or multi-detector computed tomography of the pulmonary arteries

(MDCT). The basic principle for the diagnosis of PE based upon V/P

scintigraphy is to recognize lung segments or subsegments without perfusion but

preserved ventilation, i.e., mismatch. Ventilation studies are in general performed

after inhalation of Kr-labelled or technetium-labelled aerosol of diethylene triamine

pentaacetic acid (DTPA) or Technegas. Perfusion studies are performed after

intravenous injection of macro-aggregated human albumin. Radiation exposure

using documented isotope doses is 1.2 to 2 mSv. Planar and tomographic

techniques (Planar V/P and SPECT V/P) are analyzed. Single photon emission

computed tomography V/P has higher sensitivity and specificity than Planar V/P.

The interpretation of either Planar V/P or SPECT V/P should follow holistic

principles rather than obsolete probabilistic rules. Pulmonary embolism should be

reported when mis-match of more than 1 subsegment is found. For the diagnosis

of chronic PE, V/P scintigraphy is of value. The additional diagnostic yield from V/P

scintigraphy includes chronic obstructive lung disease (COPD), heart failure and

pneumonia. Single photon emission computed tomography V/P is strongly

preferred to Planar V/P as the former permits the accurate diagnosis of PE even in

the presence of co-morbid diseases such as COPD and pneumonia.

The EANM's practice guidelines on VP scintigraphy also noted that to reduce the

costs, the risks associated with false-negative and false-positive diagnoses, and

unnecessary radiation exposure, pre-imaging assessment of clinical probability is

recommended. Diagnostic accuracy is approximately equal for MDCT and Planar

V/P and better for SPECT V/P, which is feasible in about 99 % of patients, while

MDCT is often contraindicated. As MDCT is more readily available, access to both

techniques is vital for the diagnosis of PE. Single photon emission computed

tomography V/P gives an effective radiation dose of 1.2 to 2 mSv. For SPECT V/P,

the effective dose is about 35 % to 40 % and the absorbed dose to the female

breast 4 % of the dose from MDCT performed with a dose-saving protocol. Thus,

SPECT V/P is recommended as a first-line procedure in patients with suspected

PE. It is particularly favored in young patients, especially females, during

pregnancy, and for follow-up and research (Bajc et al, 2009b).

Other Indications



Single photon emission computed tomography has proven useful in distinguishing

lymphoma from necrosis in the chest and abdomen. It is also useful in localizing

abscesses, and distinguishing abscess from other infectious or inflammatory

processes. Single photon emission computed tomography is also useful in

osteomyelitis in distinguishing inflammation of soft tissue from bone.

Guidelines on parathyroid scintigraphy from the Society of Nuclear Medicine

(Greenspan et al, 2004) state that there is a developing consensus that SPECT

imaging is useful, because, when used in conjunction with planar imaging, SPECT

provides increased sensitivity and more precise anatomic localization. They note

that this is particularly true in detecting both primary and recurrent

hyperparathyroidism resulting from ectopic adenomas. In the mediastinum,

accurate localization may assist in directing the surgical approach, such as median

sternotomy versus left or right thoracotomy. The Parathyroid Task Group of the

EANM (Hindie et al, 2009) stated that the use of SPECT/CT has a major role for

obtaining anatomical details on ectopic foci. However, its use as a routine

procedure before target surgery is still investigational. Preliminary data suggest

that SPECT/CT has lower sensitivity in the neck area compared to pinhole imaging.

In a review on neuroimaging in psychopathy (including anti-social personality

disorder and violent behavior), Pridmore et al (2005) noted that functional

neuroimaging strongly suggests dysfunction of particular frontal and temporal lobe

structures in subjects with psychopathy. However, there are difficulties in selecting

homogeneous index cases and appropriate control groups. These investigators

stated that further studies are needed.

An assessment of SPECT for schizophrenia by the Institute for Clinical

Effectiveness and Health Policy (Pichon Riviere et al, 2004) found that SPECT has

identified increases in dopaminergic activity in the striated body and other areas of

the brain during the episodes of schizophrenia exacerbation. Single photon

emission computed tomography has also been able to identify decreases in frontal

cortex uptake that are associated with negative symptoms of schizophrenia. The

investigators, however, were unable to find substantial evidence for the role of

SPECT scans in therapeutic decision-making in schizophrenia. They concluded

that the use of SPECT scan in schizophrenia remains investigational.




In the recent practice parameter on the diagnosis and prognosis of new onset

Parkinson's disease (PD) (an evidence-based review) by the American Academy of

Neurology (AAN), Suchowersky et al (2006) stated that SPECT scanning may not

be useful in differentiating PD from other parkinsonian syndromes.

In a meta-analysis of the literature on diagnostic accuracy of SPECT in

parkinsonian syndromes, Vlaar and colleagues (2007) concluded that SPECT with

pre-synaptic radiotracers is relatively accurate to differentiate patients with PD in an

early phase from normalcy, patients with PD from those with essential tremor, and

PD from vascular parkinsonism. The accuracy of SPECT with both pre-synaptic

and post-synaptic tracers to differentiate between PD and atypical parkinsonian

syndrome is relatively low.

The American College of Radiology's "Appropriateness Criteria® dementia and

movement disorders" (Wippold et al, 2010) stated that "[a] diminution of the width of

the pars compacta on MRI has been described in PD patients compared to

controls, with overlap between groups. This diminished width probably reflects

selective neuronal loss of the pars compacta. Other authors have found a normal

appearance of the substantia nigra on T2-weighted images in a majority of PD

patients. More recently, PET and SPECT tracer studies exploring the presynaptic

nigrostriatal terminal function and the postsynaptic dopamine receptors have

attempted to classify the various Parkinson syndromes although much of this work

remains investigational".

van der Vaart et al (2008) described the current applications of PET and SPECT as

a diagnostic tool for vascular disease as relevant to vascular surgeons. These

researchers noted that PET and SPECT may be used to assess plaque

vulnerability, biology of aneurysm progression, prosthetic graft infection, and

vasculitis. Moreover, the authors stated that considerable further information will be

needed to define whether and where PET or SPECT will fit in a clinical strategy.

The necessary validation studies represent an exciting challenge for the future but

also may require the development of inter-disciplinary imaging groups to integrate

expertise and optimize nuclear diagnostic potential.

A report by the New Zealand Health Services Assessment Collaboration (Smartt &

Campbell-Page, 2009) of combined CT and SPECT (SPECT-CT) scanning

in oncology concluded that SPECT-CT imaging in oncology requires further

assessment. The report stated that SPECT-CT imaging is being explored in a wide




range of cancers for a variety of purposes, and , that there is some evidence of an

evolving role in specific areas such as lymph node assessment and mapping and

the identification of bone metastases. There is also a growing body of literature

comparing the effectiveness and roles of SPECT-CT and PET-CT imaging in

oncology which may be expected to mature in the next few years. "However, the

quality of the evolving evidence and the cost-effectiveness of combined CT and

nuclear imaging systems have yet to be fully assessed." The report stated that

there are a number of outstanding questions relating to the clinical and cost-

effectiveness of SPECT-CT in oncology. In particular there is a need to compare

the clinical utility of hybrid scanners using low performance X-ray scanners with the

newer multislice machines to assess the additional benefits of the new generation

scanners in clinical practice. The report stated that there is also a need to assess

the impact of SPECT-CT on patients’ outcomes and management in specific

indications where SPECT imaging/ planar scintigraphy are standard practice e.g.

functional imaging of bone (bone scans). Other research needs identified in the

report include: 1) research on the cost-effectiveness of SPECT-CT imaging for

specific purposes such as lymph-node mapping and sentinel node identification; 2)

research to assess the impact of SPECT-CT on patients’ outcomes and

management in specific indications where SPECT imaging/ planar scintigraphy are

standard practice, e.g. functional imaging of bone (bone scans).

The American College of Radiology’s clinical guideline on “Head trauma” (ACR,

2012) stated that “Advanced imaging techniques (perfusion CT, perfusion MRI,

SPECT, and PET) have utility in better understanding selected head-injured

patients but are not considered routine clinical practice at this time”.

Jamadar et al (1999) stated that ventilation/perfusion scans with single-photon

emission computed tomography (SPECT) were reviewed to determine their

usefulness in the evaluation of lung volume reduction surgery (LVRS) candidates,

and as a predictor of outcome after surgery. A total of 50 consecutive planar

ventilation (99mTc-DTPA aerosol) and perfusion (99mTc-MAA) scans with

perfusion SPET of patients evaluated for LVRS were retrospectively reviewed.

Technical quality and the severity and extent of radiotracer defects in the upper and

lower halves of the lungs were scored from visual inspection of planar scans and

SPET data separately. An emphysema index (EI) (extent x severity) for the upper

and lower halves of the lung, and an EI ratio for upper to lower lung were calculated

for both planar and SPET scans. The ratios were compared with post-LVRS

outcomes, 3, 6 and 12 months after surgery. All perfusion and SPET images were




technically adequate. Forty-six percent of ventilation scans were not technically

adequate due to central airway tracer deposition. Severity, extent, EI scores and EI

ratios between perfusion and SPET were in good agreement (r = 0.52 to 0.68).

The mean perfusion EI ratio was significantly different between the 30 patients

undergoing bi-apical LVRS and the 17 patients excluded from LVRS (3.3 +/- 1.8

versus 1.2 +/- 0.7; p < 0.0001), in keeping with the anatomic distribution of

emphysema by which patients were selected for surgery by computed tomography

(CT). The perfusion EI ratio correlated moderately with the change in FEV1 at 3

months (r = 0.37, p = 0.04), 6 months (r = 0.36, p = 0.05), and 12 months (r = 0.42,

p = 0.03), and the transition dyspnea index at 6 months (r = 0.48, p = 0.014) after

LVRS. The authors concluded that patients selected to undergo LVRS have more

severe and extensive apical perfusion deficits than patients not selected for LVRS,

based on CT determination. Moreover, they stated that SPECT after aerosol V/Q

imaging does not add significantly to planar perfusion scans. Aerosol DTPA

ventilation scans are not consistently useful. Perfusion lung scanning may be

useful in selecting patients with successful outcomes after LVRS.

Inmai and colleagues (2000) noted that 99mTc-Technegas (Tcgas) SPECT is

useful for evaluating the patency of the airway and highly sensitive in detecting

regional pulmonary function in pulmonary emphysema. The aim of this study was

to evaluate regional ventilation impairment by this method pre- and post-

thoracoscopic LVRS in patients with pulmonary emphysema. There were 11

patients with pulmonary emphysema. The mean age of patients was 64.1 years.

All patients were males. LVRS was performed bilaterally in 8 patients and

unilaterally in 3 patients. Post-inhalation of Tcgas in the sitting position, the

subjects were placed in the supine position and SPECT was performed.

Distribution of Tcgas on axial images was classified into 4 types: (i) homogeneous

(ii) inhomogeneous (iii) hot spot, and (iv) defect. Three slices of axial SPECT

images, the upper, middle and lower fields were selected, and changes in

deposition patterns post LVRS were scored (Tcgas score). Post-LVRS, dyspnea

on exertion and pulmonary function tests were improved. Pre-LVRS,

inhomogeneous distribution, hot spots and defects were observed in all patients.

Post-LVRS, improvement in distribution was obtained not only in the surgical field

and other fields, but also in the contralateral lung of unilaterally operated patients.

In 5 patients some fields showed deterioration. The Tcgas score correlated with

improvements in FEV1.0, FEV1.0 % and % FEV1.0. The authors concluded that

Tcgas SPECT is useful for evaluating changes in regional pulmonary function post-

LVRS.




Also, an UpToDate review on “Lung volume reduction surgery in COPD” (Martinez,

2014) does not mention the use of SPECT for pre-surgical evaluation.

Nakai et al (2014) reported the case of an 84-year old woman who presented with

persistent type II endoleak with sac expansion from 57 mm to 75 mm during 4-year

follow-up after endovascular abdominal aortic aneurysm repair. The patient

underwent trans-abdominal embolization with coils and N-butyl

cyanoacrylate/ethiodized oil mixture (2.5 ml). Because of the anticipated

embolization artifacts on follow-up computed tomography (CT), technetium-99m-

labeled human serum albumin diethylenetriamine pentaacetic acid single-photon

emission computed tomography ((99m)Tc-HSAD SPECT) was performed before

and after the intervention. Peri-graft accumulation on (99m)Tc-HSAD SPECT

corresponding to the endoleak disappeared after embolization. The authors noted

that CT scan performed 12 months after embolization showed no signs of sac

expansion; and they stated that (99m)Tc-HSAD SPECT may be useful for

evaluating therapeutic effect after embolization for endoleak.

The American College of Radiology Appropriateness Criteria on “Dementia and

movement disorders” (ACR, 2014) stated that “An evidence-based review

performed by the AAN concluded that SPECT imaging cannot be recommended for

either the initial or the differential diagnosis of suspected dementia because it has

not demonstrated superiority to clinical criteria. Also, compared with PET, SPECT

has a lower diagnostic accuracy and is inferior in its ability to separate healthy

controls from patients with true dementia”.

Freesmeyer et al (2014) reported an initial experience regarding the feasibility and

applicability of quasi-integrated freehand SPECT/ultrasonography (US) fusion

imaging in patients with thyroid disease. Local ethics committee approval was

obtained, and 34 patients were examined after giving written informed consent.

After intravenous application of 75 MBq of technetium 99m pertechnetate, freehand

3-D SPECT was performed. Data were reconstructed and transferred to a US

system. The combination of 2 independent positioning systems enabled real-time

fusion of metabolic and morphologic information during US examination. Quality of

automatic co-registration was evaluated visually, and deviation was determined by

measuring the distance between the center of tracer distribution and the center of

the US correlate. All examinations were technically successful. For 18 of 34

examinations, the automatic co-registration and image fusion exhibited very good

agreement, with no deviation. Only minor limitations in fusion offset occurred in 16




patients (mean offset ± standard deviation, 0.67 cm ± 0.3; range of 0.2 to 1.0 cm).

SPECT artifacts occurred even in situations of clear thyroid findings (e.g., unifocal

autonomy). The authors concluded that the freehand SPECT/US fusion concept

proved feasible and applicable; however, technical improvements are needed.

Ryken et al (2014) determined which imaging techniques most accurately

differentiate true tumor progression from pseudo-progression or treatment-related

changes in patients with previously diagnosed glioblastoma. The authors stated

that the following recommendations apply to adults with previously diagnosed

glioblastoma who are suspected of experiencing progression of the neoplastic

process:

▪ Recommendation Level II: Magnetic resonance imaging (MRI) with and

without gadolinium enhancement is recommended as the imaging

surveillance method to detect the progression of previously diagnosed

glioblastoma.

▪ Recommendation Level II: Magnetic resonance spectroscopy (MRS) is

recommended as a diagnostic method to differentiate true tumor

progression from treatment-related imaging changes or pseudo-

progression in patients with suspected progressive glioblastoma.

▪ Recommendation Level III: The routine use of positron emission

tomography (PET) to identify progression of glioblastoma is not

recommended.

▪ Recommendation Level III: Single-photon emission computed tomography

(SPECT) imaging is recommended as a diagnostic method to differentiate

true tumor progression from treatment-related imaging changes or pseudo-

progression in patients with suspected progressive glioblastoma.

The National Comprehensive Cancer Network’s clinical practice guideline on

“Central nervous system cancers” (Version 2.2014) does not mention SPECT as a

management tool. Furthermore, an UpToDate review on “Management of recurrent

high-grade gliomas” (Batchelor et al, 2015) does not mention SPECT as a

management tool.

Detection of Fronto-Temporal Dementia

In a Cochrane review, Archer et al (2015) determined the diagnostic accuracy of

regional cerebral blood flow (rCBF) SPECT for diagnosing FTD in populations with




suspected dementia in secondary/tertiary healthcare settings and in the differential

diagnosis of FTD from other dementia subtypes. The search strategy used 2

concepts: (i) the index test and (ii) the condition of interest. These investigators

searched citation databases, including MEDLINE (Ovid SP), EMBASE (Ovid SP),

BIOSIS (Ovid SP), Web of Science Core Collection (ISI Web of Science),

PsycINFO (Ovid SP), CINAHL (EBSCOhost) and LILACS (Bireme), using

structured search strategies appropriate for each database. In addition they

searched specialized sources of diagnostic test accuracy studies and reviews

including: MEDION (Universities of Maastricht and Leuven), DARE (Database of

Abstracts of Reviews of Effects) and HTA (Health Technology Assessment)

database. These researchers requested a search of the Cochrane Register of

Diagnostic Test Accuracy Studies and used the related articles feature in PubMed

to search for additional studies. They tracked key studies in citation databases

such as Science Citation Index and Scopus to ascertain any further relevant

studies. They identified “grey” literature, mainly in the form of conference abstracts,

through the Web of Science Core Collection, including Conference Proceedings

Citation Index and Embase. The most recent search for this review was run on the

June 1, 2013. Following title and abstract screening of the search results, full-text

papers were obtained for each potentially eligible study. These papers were then

independently evaluated for inclusion or exclusion. The authors included both

case-control and cohort (delayed verification of diagnosis) studies. Where studies

used a case-control design , these researchers included all participants who had a

clinical diagnosis of FTD or other dementia subtype using standard clinical

diagnostic criteria. For cohort studies, they included studies where all participants

with suspected dementia were administered rCBF SPECT at baseline. The authors

excluded studies of participants from selected populations (e.g., post-stroke) and

studies of participants with a secondary cause of cognitive impairment. Two review

authors extracted information on study characteristics and data for the assessment

of methodological quality and the investigation of heterogeneity. They assessed

the methodological quality of each study using the QUADAS-2 (Quality Assessment

of Diagnostic Accuracy Studies) tool. They produced a narrative summary

describing numbers of studies that were found to have high/low/unclear risk of bias

as well as concerns regarding applicability. To produce 2 x 2 tables, these

investigators dichotomized the rCBF SPECT results (scan positive or negative for

FTD) and cross-tabulated them against the results for the reference standard.

These tables were then used to calculate the sensitivity and specificity of the index

test. Meta-analysis was not performed due to the considerable between-study

variation in clinical and methodological characteristics.




A total of 11 studies (1,117 participants) met inclusion criteria. These consisted of

6 case-control studies, 2 retrospective cohort studies and 3 prospective cohort

studies; 3 studies used single-headed camera SPECT while the remaining 8 used

multiple-headed camera SPECT. Study design and methods varied widely.

Overall, participant selection was not well-described and the studies were judged

as having either high or unclear risk of bias. Often the threshold used to define a

positive SPECT result was not pre-defined and the results were reported with

knowledge of the reference standard. Concerns regarding applicability of the

studies to the review question were generally low across all 3 domains (participant

selection, index test and reference standard). Sensitivities and specificities for

differentiating FTD from non-FTD ranged from 0.73 to 1.00 and from 0.80 to 1.00,

respectively, for the 3 multiple-headed camera studies. Sensitivities were lower for

the 2 single-headed camera studies; 1 reported a sensitivity and specificity of 0.40

(95 % CI: 0.05 to 0.85) and 0.95 (95 % CI: 0.90 to 0.98), respectively, and the other

a sensitivity and specificity of 0.36 (95 % CI: 0.24 to 0.50) and 0.92 (95 % CI: 0.88

to 0.95), respectively. Eight of the 11 studies which used SPECT to differentiate

FTD from Alzheimer's disease used multiple-headed camera SPECT. Of these

studies, 5 used a case-control design and reported sensitivities of between 0.52

and 1.00, and specificities of between 0.41 and 0.86. The remaining 3 studies used

a cohort design and reported sensitivities of between 0.73 and 1.00, and

specificities of between 0.94 and 1.00. The 3 studies that used single-headed

camera SPECT reported sensitivities of between 0.40 and 0.80, and specificities of

between 0.61 and 0.97. The authors concluded that they would not recommend

the routine use of rCBF SPECT in clinical practice because there is insufficient

evidence from the available literature to support this. They stated that further

research into the use of rCBF SPECT for differentiating FTD from other dementias

is needed. In particular, protocols should be standardized, study populations

should be well-described, the threshold for “abnormal” scans pre-defined and clear

details given on how scans are analyzed. The authors stated that more prospective

cohort studies that verify the presence or absence of FTD during a period of follow-

up should be undertaken.

Detection of Air Leak/Pneumothorax

Ceulemans et al (2012) reported on the case of a 61-year old man with severe

chronic obstructive pulmonary disease presented to the authors’ hospital with

recurrence of a right-sided spontaneous secondary pneumothorax. Thoracoscopic

abrasion of the parietal pleura was performed, but an important air leak persisted.




Presumed to originate from a bulla in the right upper lobe, bullectomy and pleural

decortication were performed, but leakage remained. Lobectomy was considered,

and quantitative ventilation/perfusion SPECT was performed to predict the

functional outcome. Fused high-resolution CT/Tc Technegas images localized

leakage not only to a bleb in the right upper lobe but also to the subcutaneous

emphysema in the thoracic wall. The air leak resolved after conservative treatment.

An UpToDate review of “Imaging of pneumothorax” (Stark, 2016) mentions cheat

X-ray, CT, and ultrasound for imaging pneumothorax; it does not mention SPECT

scan.

Diagnosis of Lung Cancer

In a meta-analysis, Zhang and Liu (2016) examined the value of technetium-99m

methoxy isobutyl isonitrile (Tc-MIBI) SPECT in differentiating malignant from benign

lung lesions. The PubMed and Embase databases were comprehensively

searched for relevant articles that evaluated lung lesions suspicious for malignancy.

Two reviewers independently extracted the data on study characteristics and

examination results, and assessed the quality of each selected study. The data

extracted from the eligible studies were assessed by heterogeneity and threshold

effect tests. Pooled sensitivity, specificity, diagnostic odds ratio (DOR), and areas

under the summary receiver-operating characteristic curves (SROC) were also

calculated. A total of 14 studies were included in this meta-analysis. The pooled

sensitivity, specificity, positive and negative likelihood ratio, and DOR of Tc-MIBI

scan in detecting malignant lung lesions were 0.84 (95 % CI: 0.81 to 0.87), 0.83 (95

% CI: 0.77 to 0.88), 4.22 (95 % CI: 2.53 to 7.04), 0.20 (95 % CI: 0.12 to 0.31), and

25.71 (95 % CI: 10.67 to 61.96), respectively. The area under the SROC was

0.9062. Meta-regression analysis showed that the accuracy estimates were

significantly influenced by ethnic groups (p < 0.01), but not by image analysis

methods, mean lesion size, or year of publication. Deek funnel plot asymmetry test

for the overall analysis did not raise suspicion of publication bias (p = 0.50). The

authors concluded that these findings indicated that Tc-MIBI scan is a promising

diagnostic modality in predicting the malignancy of lung lesions.

This meta-analysis had several drawbacks: (i) the studies varied in year of

publication, sample size, continuity of patients enrolled, and ethnic groups as

well as lesion size. In addition, 99mTc-MIBI SPECT images were performed

under variable conditions, including tracer dose, image analysis methods, the




interval time between tracer injection and scanning (ii) it is impossible for these

researchers to identify all studies of 99mTc-MIBI SPECT for lung cancer

diagnosis, especially unpublished studies. Since articles reporting significant

results are more likely to be published than those reporting non-significant results,

publication bias is a major concern in meta-analysis. However, the Deek funnel

plot asymmetry test for the overall analysis did not raise suspicion of publication

bias. In addition, the authors adopted rigid inclusion criteria and they selected only

articles that included at least 10 patients who performed MIBI imaging for lung

lesions, which may bring about selection bias, and (iii) it was not clear whether

SPECT or PET is superior in differentiating malignant from benign lesions. Two

recent published meta-analyses were performed to evaluate the diagnostic

accuracy of FDG-PET for detecting lung cancer with a sensitivity of 94 % to 96 %

and specificity of 78 % to 86 %. However, a direct comparison between PET and

SPECT is absent. Only 2 of the studies comparing SPECT with PET were included

in this meta-analysis, but the results were generally inconclusive. According to

Santini et al, 99mTc-MIBI SPECT was similar to FDG-PET in the detection of lung

malignancies and represents an alternative if PET was not available.

Furthermore, National Comprehensive Cancer Network’s clinical practice guidelines

on “Small cell lung cancer” (Version 2.2017) and “Non-small cell lung

cancer” (Version 4.2017) do not mention SPECT as a diagnostic tool.

Evaluation of Carotid Stenosis:

Sato and Matsumoto (2017) stated that multi-phase arterial spin labeling (ASL),

which obtains the imaged slices with various post-labeling delays, allows for the non-

invasive assessment of cerebral hemodynamics that cannot be adequately acquired

by SPECT imaging. These investigators described the clinical usefulness of multi-

phase ASL in a patient with symptomatic carotid stenosis by comparison with

SPECT at rest using iodo-amphetamine. A 75-year old man was referred to the

authors’ hospital with severe stenosis of the left internal carotid artery (ICA).

While SPECT showed no significant laterality of CBF, multi-phase ASL

demonstrated relatively delayed perfusion in the left ICA territory. The patient

underwent stent placement for the left ICA stenosis. Post-operatively, while

SPECT demonstrated no significant laterality of CBF, multi-phase ASL revealed

improved perfusion in the left ICA territory. The authors concluded that this case

showed that multi-phase ASL could accurately evaluate the cerebral hemodynamic

status that could not be detected using pre- and post-operative SPECT.




Imaging Marker of Pre-Diagnostic Parkinson's Disease:

Noyce and colleagues (2018) examined if pre-diagnostic features of PD were

associated with changes in dopamine re-uptake transporter-SPECT and

transcranial sonography. Pre-diagnostic features of PD (risk estimates, University

of Pennsylvania Smell Identification Test, Rapid Eye Movement Sleep Behavior

Disorder Screening Questionnaire, and finger-tapping scores) were assessed in a

large cohort of older U.K. residents. A total of 46 participants were included in

analyses of pre-diagnostic features and MDS-UPDRS scores with the striatal

binding ratio on dopamine reuptake transporter-SPECT and nigral hyper-

echogenicity on transcranial sonography. The striatal binding ratio was associated

with PD risk estimates (p = 0.040), University of Pennsylvania Smell Identification

Test (p = 0.002), Rapid Eye Movement Sleep Behavior Disorder Screening

Questionnaire scores (p = 0.024), tapping speed (p = 0.024), and MDS-UPDRS

motor scores (p = 0.009). Remotely collected assessments explained 26 % of

variation in the striatal binding ratio. The inclusion of MDS-UPDRS motor scores

did not explain additional variance. The size of the nigral echogenic area on

transcranial sonography was associated with risk estimates (p < 0.001) and MDS-

UPDRS scores (p = 0.03) only. The authors concluded that the dopamine re-

uptake transporter-SPECT results correlated with motor and non-motor features of

pre-diagnostic PD, supporting its potential use as a marker in the prodromal phase

of PD; transcranial sonography results also correlated with risk scores and motor

signs.

Work-Up of Individuals Undergoing Non-Cardiac Surgery:

Al-Oweidi and colleagues (2017) noted that the prevalence and predictors of

myocardial ischemia before non-cardiac surgery are unknown. In addition the

predictive value of myocardial perfusion SPECT before non-cardiac in individual

patients is uncertain. In a retrospective study, these researchers evaluated the

prevalence and predictors of myocardial ischemia before non-cardiac surgery, and

determined the post-operative cardiac outcome based on results of myocardial

perfusion SPECT. These investigators reviewed the records of adult patients

diagnosed with myocardial ischemia by myocardial perfusion SPECT who were

undergoing non-cardiac surgery. Myocardial perfusion SPECT had been

performed within 4 weeks prior to non-cardiac surgery requiring general

anesthesia. Main outcome measures included prevalence of abnormal myocardial

perfusion SPECT results on pre-operative evaluation; abnormal myocardial





perfusion SPECT results as a predictor for post-operative cardiac events such as

cardiac death, non-fatal MI, and unstable angina. Of 131 patients who underwent

non-cardiac surgery from February 2015 to April 2016, 84 (64 %) patients were

women and the mean (SD) age was 64.1 (13.6) years. The prevalence of

abnormal myocardial perfusion SPECT was 18 % (24 of 131). Normal myocardial

perfusion SPECT was highly predictive (up to 100 %), but a positive myocardial

perfusion SPECT had low positive predictive value (PPV; 4 %). Variables

associated with an abnormal myocardial perfusion SPECT included ischemic heart

disease, congestive heart failure, American Society of Anesthesiology physical

status classification score of 3 or more, limited exercise capacity (less than 4

metabolic equivalents [METs]), male sex, hypercholesterolemia, hypertension,

smoking, and abnormal ECG. In a multi-variable analysis, history of ischemic heart

disease and history of smoking were significant predictors of abnormal myocardial

perfusion SPECT (p = 0.001, and 0.029, respectively). The authors concluded that

because of the low PPV of myocardial perfusion SPECT, utilization of the technique

in the work-up of cardiac patients undergoing non-cardiac surgery has been

inappropriate. They stated that myocardial perfusion SPECT should be restricted

to only clearly defined appropriate use criteria.

CPT Codes / HCPCS Codes / ICD-10 Codes

Information in the [brackets] below has been added for clarification purposes. Codes requiring a 7th character are represented by "+":

Code Code Description

Noncardiac indications:

CPT codes covered if selection criteria are met:

78071 Parathyroid planar imaging (including subtraction, when performed); with

tomographic (SPECT)

78072 Parathyroid planar imaging (including subtraction, when performed); with

tomographic (SPECT), and concurrently acquired computed tomography

(CT) for anatomical localization

78205 Liver imaging (SPECT)

78206 with vascular flow

78320 Bone and/or joint imaging; tomographic (SPECT)

78607 Brain imaging, complete study; tomographic (SPECT)

78647 Cerebrospinal fluid flow, imaging (not including introduction of material);

tomographic (SPECT)

09/03/2018


http://qawww.aetna.com/cpb/medical/data/300_399/0376_draft.html 09/03



78803 Radiopharmaceutical localization of tumor or distribution of

radiopharmaceutical agent(s); tomographic (SPECT)

78807 Radiopharmaceutical localization of inflammatory process; tomographic

(SPECT)

Other CPT codes related to the CPB:

78608 - 78609 Brain imaging, positron emission tomography (PET)

HCPCS codes covered if selection criteria are met:

A9584 Iodine I-123 Ioflupane, diagnostic, per study dose, up to 5 millicuries

Other HCPCS codes related to the CPB:

A9500 Technetium tc-99m sestamibi, diagnostic, per study dose

ICD-10 codes covered if selection criteria are met:

C16.0 - C16.9 Malignant neoplasm of stomach [carcinoid or neuroendocrine tumors]

C25.0 - C25.9 Malignant neoplasm of pancreas [VIPoma, Islet cell tumors]

C33 Malignant neoplasm of trachea

C70.0 - C70.9 Malignant neoplasm of cerebral meninges [meningioma]

C71.0 - C71.9 Malignant neoplasm of brain [differentiation of necrotic tissue from

tumor]

C74.00 - C74.92 Malignant neoplasm of adrenal gland [paragangliomas,

pheochromocytomas]

C75.0 - C75.2 Malignant neoplasm of parathyroid gland, pituitary gland and

craniopharyngeal duct

C75.5 Malignant neoplasm of aortic body and other paraganglia

C7A.00 - C7B.8 Malignant neuroendocrine tumors

C79.31, C79.49 Secondary malignant neoplasm of brain and nervous system

[differentiation of necrotic tissue from tumor of the brain]

C81.00 - C88.9 Lymphoma [to distinguish tumor from necrosis]

D13.7 Benign neoplasm of endocrine pancreas [gastrinomas, glucagonomas,

Islet cell tumors]

D18.03 Hemangioma of intra-abdominal structures [liver]

D32.0 - D32.9 Benign neoplasm of meninges [meningioma]

D33.0 - D33.2 Benign neoplasm of brain [differentiation of necrotic tissue from tumor]

/2018





D35.00 - D35.02 Benign neoplasm of adrenal gland [paragangliomas,

pheochromocytomas]

D35.1 - D35.3 Benign neoplasm of parathyroid gland, pituitary gland and

craniopharyngeal duct (pouch)

D35.6 Benign neoplasm of aortic body and other paraganglia

D37.1 - D37.5 Neoplasm of uncertain behavior of stomach, intestines, and rectum

D37.8 - D37.9 Neoplasm of uncertain behavior of other and unspecified digestive

organs

D38.1 Neoplasm of uncertain behavior of trachea, bronchus, and lung

D42.0 - D42.9 Neoplasm of uncertain behavior of meninges

D43.0 - D43.4 Neoplasm of uncertain behavior of brain and spinal cord [differentiation

of necrotic tissue from tumor of the brain]

D44.0 - D44.9 Neoplasm of uncertain behavior of endocrine glands

E20.0 - E21.5 Disorders of parathyroid gland

E34.0 Carcinoid syndrome

G20 Parkinson's disease

G40.001 -

G40.919

Epilepsy and recurrent seizures [presurgical ictal detection of seizure

focus in place of PET]

I26.01 - I26.99 Pulmonary embolism

K12.2 Cellulitis and abscess of mouth

L02.01, L02.11

L02.211

L02.219

L02.31

L02.411

L02.419

L02.511

L02.519

L02.611

L02.619

L02.811

L02.818

L02.91

Other cutaneous abscess [localization for suspected or known localized

infection or inflammatory process]

09/03/2018




L03.111

L03.119

L03.121

L03.129

L03.211

L03.213

L03.221

L03.222

L03.311

L03.319

L03.321

L03.329

L03.818

L03.891

L03.898

L03.90 -L03.91

Other cellulitis [localization for suspected or known localized infection or

inflammatory process]

L98.3 Eosinophillic cellulitis [Wells]

M46.20 -

M46.28

Osteomyelitis of vertebra [to distinguish bone from soft tissue infection]

M46.30 -

M46.39

Infection of intervertebral disc (pyogenic) [to distinguish bone from soft

tissue infection]

M48.40x+

M48.48x+

M84.30x+

M84.38x+

M84.361+ -

M84.369+

M84.374+ -

M84.379+

Stress fractures

M86.011 -

M86.9

Osteomyelitis, periostitis, and other infections involving bone [to

distinguish bone from soft tissue infection]

M89.60 -

M89.69

Osteopathy after poliomyelitis [to distinguish bone from soft tissue

infection]

M90.80 -

M90.89

Osteopathy in diseases classified elsewhere






Q76.2 Congenital spondylolisthesis

R56.1 Post traumatic seizures [presurgical ictal detection of seizure focus in

place of PET]

ICD-10 codes not covered for indications listed in the CPB:

E00.0 - E07.9 Disorders of thyroid gland

F01.50 - F01.51 Vascular dementia

F02.80 - F02.81 Dementia in other diseases classified elsewhere with or without

behavioral disturbance

F06.0 - F06.8 Other mental disorders due to known physiological condition

F10.282,

F10.982

Alcohol use with alcohol-induced sleep disorder

F11.182,

F11.282

F11.982

F13.182,

F13.282

F13.982

F14.182,

F14.282

F14.982

F15.182,

F15.282

F15.982

F19.182,

F19.282

F19.982

Drug induced sleep disorders

F20.0 - F21 Schizophrenia

F51.0 - F51.9 Sleep disorders not due to a substance or known physiological condition

F60.0 - F69 Disorders of adult personality and behaivor

F84.0 - F89 Pervasive developmental disorders

F90.0 - F90.9 Attention-deficit hyperactivity disorder

G30.0 - G30.9 Alzheimer's disease

G31.01 - G31.09 Frontotemporal dementia

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http://qawww.aetna.com/cpb/medical/data/300_399/0376_draft.html 09



G31.83 Dementia with Lewy bodies

G35 Multiple sclerosis

G47.0 - G47.9 Sleep disorders

I63.011 - I66.9 Occlusion and stenosis of precerebral arteries, occlusion of cerebral

arteries, and transient cerebral ischemia

I77.3 Arterial fibromuscular dysplasia

I77.6 Arteritis, unspecified

I77.89 Other specified disorders of arteries and arterioles

J93.0 - J93.9 Pneumothorax and air leak

M30.1 Polyarteritis with lung involvement [Churg-Strauss]

M31.0 - M31.9 Other necrotizing vasculopathies

R52 Pain, unspecified

R91.8 Other nonspecific abnormal finding of lung field

S02.0XX+

S02.42X+

S02.600+

S02.92X+

Fracture of skull and facial bones

S06.0x0+ -

S06.0x9+

Concussion

S06.310+ -

S06.339+

Contusion and laceration of cerebrum

S06.340+ -

S06.369+

Traumatic hemorrhage of cerebrum

S06.4X0+ -

S06.6X9+

Epidural and traumatic subdural hemorrhage

S06.890+ -

S06.9X9+

Other and unspecified intracranial injury

S09.8XX+ -

S09.90X+

Specified and unspecified head injury

T82.898+ Other specified complication of vascular prosthetic devices, implants

and grafts, initial encounter [endoleak]

/03/2018





T82.6xx+

T82.7xx+,

T83.51x+ -

T83.69x+,

T84.50x+ -

T84.60x+,

T84.63x+ -

T84.7xx+

T85.71x+ -

T85.79x+

Infection and inflammatory reaction due to internal prosthetic device,

implant, and graft

Z01.818 Encounter for other preprocedural examination

Cardiac Indications:

CPT codes covered if selection criteria are met:

78451 Myocardial perfusion imaging, tomographic (SPECT) (including

attenuation correction, qualitative or quantitative wall motion, ejection

fraction by first pass or gated technique, additional quantification, when

performed); single study, at rest or stress (exercise or pharmacologic)

78452 multiple studies, at rest and/or stress (exercise or pharmacologic)

and/or redistribution and/or rest reinjection

78453 Myocardial perfusion imaging, planar (including qualitative or

quantitative wall motion, ejection fraction by first pass or gated

technique, additional quantification, when performed); single study, at

rest or stress (exercise or pharmacologic)

78454 multiple studies, at rest and/or stress (exercise or pharmacologic)

and/or redistribution and/or rest reinjection

78469 Myocardial imaging, infarct avid, planar; tomographic SPECT with or

without quantification

CPT codes not covered for indications listed in the CPB:

0331T Myocardial sympathetic innervation imaging, planar qualitative and

quantitative assessment

0332T Myocardial sympathetic innervation imaging, planar qualitative and

quantitative assessment; with tomographic SPECT

Other CPT codes related to the CPB:

33140 - 33141 Transmyocardial revascularization

09/03/2018





ICD-10 codes covered if selection criteria are met:

I25.10 - I25.9 Atherosclerotic heart disease of antive coronary artery

ICD-10 codes not covered for indications listed in the CPB:

I21.01 - I24.1 ST elevation (STEMI) and non-ST elevation (NSTEMI) myocardial

infarction

R57.0 - R57.9 Shock, not elsewhere classified

Z13.6 Encounter for screening for cardiovascular disorders

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Copyright Aetna Inc. All rights reserved. Clinical Policy Bulletins are developed by Aetna to assist in administering plan

benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial,

general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care

services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in

private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible

for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to

change.

Copyright © 2001-2018 Aetna Inc.



AETNA BETTER HEALTH® OF PENNSYLVANIA

Amendment to Aetna Clinical Policy Bulletin Number:

0376 Single Photon Emission Computed Tomography (SPECT) There are no amendments for Medicaid.

www.aetnabetterhealth.com/pennsylvania revised 08/01/2018

http://www.aetnabetterhealth.com/pennsylvania

this cpb has been revised to state that spect is …...single photon emission computed tomography...

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