a american college of radiology imaging network 6652 c r i ... forms... · cs quality of life...

ACRIN Study 6652

A0 Registration Form

BX Biopsy Form

CS Quality of Life Coversheet

F1 Breast Cancer Status

I1 Initial Evaluation Form

IA Study Mammography Interpretation - Film Screen

ID Study Mammography Interpretation - Digital

IE Follow-up Mammography Interpretation

IM Additional Work-up

QP Pre-Screening Mammography - Patient Self-Administered

QL Baseline Post Screening Mammography Telephone Survey

QF Follow-up Post Mammography Telephone Survey

P4 Core Pathology Interpretation

PL Interpretation of Local Pathology

P0 Second Core Pathology Interpretation

TA Technical Assessment

PC Pathology Submission Form

Confidential Patient Contact Form

Patient Non-Participation Form

American College of Radiology Imaging Network

Forms Package Index

A C R I N

ACRIN Study 6652 Case #

6652 A0 4/02 1 of 1

Patient's I.D. No.

Institution No.Institution

Patient's Name

PLACE LABEL HERE

INSTRUCTIONS: *Eligibility - Questions 18-27 are for Potential Study Participants. If any of the questions areanswered in a way different from the prompts provided at the start of each question, the patient is ineligible andshould not be enrolled.Proceed with Questions 1-17 after the patient is determined eligible. These questions are prompted at thetime of case registration. Please pay attention to supplementary instructions on particular questions.

If this is a revised orcorrected form, indicateby checking box.

ACRINRegistration Form/Eligibility Checklist

The following questions will be asked at study registration:

______________ 1. Name of institutional person registering this case.

______________ (Y) 2. Has the eligibility checklist been completed?

______________ (Y) 3. Is the patient eligible for this study?

____-_____-_______ 4. Date the study specific consent form was signed (mm/dd/yyyy) (Must be prior to study entry)

______________ 5. Patient’s Name or Initials (last, first) (L., F.)

______________ 6. Verifying Physician

XXXXXXXXXX 7. Patient’s ID Number (do not use medical record number or radiology file number)

______________ 8. Date of birth (mm/dd/yyyy)

______________ 9. Race

XXXXXXXXXX 10. Social Security Number (optional field, code 999-99-9999)

XXXXXXXXXX 11. Gender

______________ 12. Patient’s Country of Residence

______________ 13. Zip Code (U.S. residents only)

______________ 14. Patient’s Insurance Status

______________ 15. Will any component of the patient’s care be given at a military or VA facility?

______________ 16. Date of Protocol Imaging

______________ 17. Date of Randomization

______________ (N) 18. Is this patient enrolled in other digital mammography trials (where the film-screen mammogram would not be able to be provided for this study)?

______________ 19. Year of first baseline mammogram

______________ (Y) 20. Is the patient scheduled for screening mammography?

______________ (N) 21. Does the patient have a focal dominant lump?

______________ (N) 22. Does the patient have a bloody or clear discharge?

______________ (N) 23. Does the patient have breast implants?

______________ (N) 24. Is the patient pregnant, nursing, or does she have any reason to believe she may be pregnant?

______________ (Y) 25. Does the patient understand and agree to the follow-up requirements as outlined in Section 8.0 of the protocol?

______________ (N) 26. Does the patient have a history of breast cancer treated with lumpectomy?

______________ (N/Y) 27. Does the patient have a history of breast cancer treated with mastectomy?

______________ 28. Month/Year of last mammogram (mm/yyyy)

______________ (N/Y) 29. Has the patient signed the "20 year" consent?

Completed by ______________________ Date ___-___-_____ (mm-dd-yyyy)

A0


6652 BX 4/02 1 of 1

Patient's I.D. No.


Patient's Name

PLACE LABEL HERE

INSTRUCTIONS: This form is to be completed after each biopsy during the follow-up period specified in section 8.0of the protocol. Complete a separate form for each biopsy procedure performed on the participant.


American College of RadiologyImaging NetworkBiopsy Form

BX

1. Was a biopsy performed? (If no biopsy was done,specify a reason in Q3)o Noo Yes

2. Procedure Date _____/____/______ (mm/dd/yyyy)

3. Specify reason biopsy was not done (If other,specify in Q4)

1 Medical contraindication2 Technical difficulties3 Patient discomfort4 Patient refusal5 Other

4. Other reason biopsy not done.

___________________________________________

5. Referred from:o Study mammographyo Follow-up mammography, specify time point

o 3 montho 6 montho 1 year

o Other, specify __________

6. Site of biopsy(If patient has had both breasts biopsied, complete aseparate form for each biopsy.)o Righto Left

7. Biopsy procedureo FNAo Core Needle

o US guidedo Stereotactico Palpation guidedo Mammography (not stereotactic)o Other, specify ____________

o Excisiono Needle localizationo Palpation guided

o Unknown

8. Location: O’clock (check all that apply)1-2

2-3

3-4

4-5

5-6

6-7

7-8

8-9

9-10

10-11

11-12

12-1

Axillary tail

Subareolar nipple

9. Depth o Anterior o Central o Posterior o Anterior and central o Central and posterior o Anterior, central and posterior

10. Cancer DiagnosisWas there a diagnosis of cancer from this biopsy?o Noo Yeso Indeterminate, another biopsy recommended

Comments:

______________________________________________________________________________________________________

Form completed by __________________________________

Date ____-_____-______


6652 CS 4/02 1 of 1

Patient's I.D. No.


Patient's Name

PLACE LABEL HERE

INSTRUCTIONS: This form represents the first page of the QP, QL and QF questionnaires. The coversheet iscompleted by the medical staff (nurse, research associate, physician, etc,) each time the participant is scheduledto complete the questionnaires. Please pay particular attention to the version administered to the participant asthey vary with time point. (i.e., pre and post imaging as well as the 12 month interval).


American College of RadiologyImaging NetworkQuality of Life Coversheet

CS

1 This coversheet submission represents (check one)o 1 QP [EQ-5D and STAI Y-6 (patient self-

administered)]o 2 QL [EQ-5D and STAI Y-6 (telephone baseline)]o 3 QF [EQ-5D, STAI Y-6, and PQ (telephone follow-

up)]

2 Scheduled data point ( check one)o 1 Pre-screening mammography

___-___-____ date imaging performedo 2 Post screening mammography*o 3 Twelve month follow-upo 4 Other, specify,__________________________

a. *If Post-Screening Mammography …Was biopsy done before this questionnaire?o Noo Yes Date of biopsy: ___-___-_____

(mm/dd/yyyy)

3 Questionnaire Compliancea. Did participant answer any questionnaire

items?o Noo Yes, ___/___/____ date questionnaire

completedo N/A

b. If no, please state reason:o Patient refusedo Patient is ill or hospitalizedo Patient deceasedo Patient is out of the countryo Incorrect contact informationo Telephone disconnected/no phoneo Patient unable to be contactedo Non-English speakingo Other, specify ________________________

Form completed by __________________________________

Date ____-_____-______


6652 F1 6-04-03 1 of 3

Patient's I.D. No.Institution No.Institution

Patient's Name

PLACE LABEL HERE

INSTRUCTIONS:Complete this form anytime follow-up contact is made with the patient, short-term interim (3-6-9 mo.) or oneyear follow-up Film Screen or Digital Mammogram. The completed form is submitted to ACR.


American College of RadiologyImaging NetworkBreast Cancer Status

1. Contact Date ___-___-____ (mm/dd/yyyy)

2. Patient Statuso Alive (If pt. alive, record date last known alive, in Q1)o Dead (If pt. dead, record date of death, in Q1)o Lost (If lost, last date of contact with pt. in Q1)

Last contact informationCity _________State ________ ( 2 letter abbreviation)

Cause of Death:o Related to breast cancero Other, specify ________

3. Contact Time pointo Short interval follow-up (3-6-9 months)o One year follow-upo Other __________

4. Has the patient had an additional mammogram since theinitial screening and excluding today's visit not previouslyrecorded on any DMIST data forms?

Answer Q4a, 4b, 4c and 4d.

o Noo Yeso Unknown

4a. Were there new findings on the Mammogram? o No o Yes o Unknown

4b. Image presentationo Film Screeno Digitalo Image date: ____________________

4c. Data source (choose one)o Images were taken at your facility and interpreted

by a DMIST Study Radiologist.o Images were taken at another facility and sent for

interpretation by a DMIST Study Radiologist.o Images were taken at another facility and clinical

report was provided to your site for coding by an RA.o Other, please specify:______________________

F1

4d. BIRADS Category (based on FINAL assessment,including ALL work-up of findings)

o Category 1 Negativeo Category 2 Benign Findingo Category 3* Probably benign finding-short

term interval follow-up suggestedo Category 4* Suspicious abnormality-biopsy

should be consideredo Category 5* Highly suggestive of malignancy-

appropriate action should be taken

*If patient is classified as BIRADS category 3, 4, or 5 you mustcomplete IE form for this patient, based on this interim image. Ifyou cannot obtain the images for interpretation, complete as muchof IE Form as posible based on clinical report.

5. Has the patient had a Mammogram at this visit? o No o Yes

*Complete 5a, 5b, 5c and 5d for all patients with a one-yearfollow-up mammogram, regardless of the date of follow-uptaken 11 months or more after study entry.

5a. Were there new findings on that mammogram?o Noo Yes

5b. Image presentation o Film Screen o Digital o Image date: _____________________

5c. Data source (choose one)

o Images were taken at your facility and interpretedby a DMIST Study Radiologist.

o Images were taken at another facility and sent forinterpretation by a DMIST Study Radiologist.

o Images were taken at another facility and clinicalreport was provided to your site for coding by anRA.

o Other, please specify:_____________________

6652 F1 6-04-03 2 of 3

REVISION ACRIN Study 6652 Case #

Patient's I.D. No.


Patient's Name

PLACE LABEL HEREF1

7. Was this patient diagnosed with breast cancer since lastcontact and not previously reported?

o No (If no, go to end of form to “Person completing form")o Yes (If yes, complete sections below)

o Date of diagnosis ___-___-______ (mm/dd/yyyy)o Right breasto Left breasto Bilateral

Location in breast:o Left Upper Outer Quadranto Left Upper Inner Quadranto Left Lower Outer Quadranto Left Lower Inner Quadranto Right Upper Outer Quadranto Right Upper Inner quadranto Right Lower Outer Quadranto Right Lower Inner quadranto Unknown

5d. BIRADS Category (based on FINAL assessment,including ALL work-up of findings)

o Category 1 Negativeo Category 2 Benign Findingo Category 3* Probably benign finding-short

term interval follow-up suggested o Category 4* Suspicious abnormality-biopsy

should be considered o Category 5* Highly suggestive of malignancy-

appropriate action should be taken

*If patient is classified as BIRADS category 3, 4, or 5 you mustcomplete IE form for this patient.

6. Has this patient had breast biopsy(ies) since last contactand not previously reported?

o Noo Yes (If Yes, complete forms PL and P4 and submit

pathology slides to Pathology Core)o Unknown

If yes, provide the following information:

Most recent biopsy:o Right Breast Date ____-____-______o Left Breast Date ____-____-______o Bilateral Date ____-____-______

Second most recent biopsy:o Right Breast Date ____-____-______o Left Breast Date ____-____-______o Bilateral Date ____-____-______

Third most recent biopsy:o Right Breast Date ____-____-______o Left Breast Date ____-____-______o Bilateral Date ____-____-______

Fourth most recent biopsy:o Right Breast Date ____-____-______o Left Breast Date ____-____-______o Bilateral Date ____-____-______

o Symptoms/Presentation:o Palpable lesiono Biopsyo Mammogram finding

o Study Entry Mammogramo Additional Mammogram

Date ____-____-_____o Other, specify __________

o Radiation Therapyo Noo Yeso Unknown

o Right breasto Left breasto BilateralStart date ___-___-____ Stop date ___-___-____

6652 F1 6-04-03 3 of 3


Patient's I.D. No.


Patient's Name

PLACE LABEL HEREF1

o Chemotherapyo Noo Yeso Unknown

Start date ___-___-____ Stop date ___-___-____

Continuing ?o Noo Yeso Unknown

o Surgeryo Noo Yeso Unknown

o Right breasto Left breasto Bilateral

Date of surgery ___-___-_____Procedure:o Lumpectomyo Mastectomy

Comments_____________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________

Form completed by__________________________________________________

Date ____-____-______


6652 I1 7/02 1 of 4

Patient's I.D. No.


Patient's Name

PLACE LABEL HERE

INSTRUCTIONS: Complete this form at time of mammogram and participant enrollment into the trial. Use “99” asa response if no code table given. All dates are reported as mm/dd/yyyy.


American College of RadiologyImaging NetworkInitial Evaluation Form

I1

1. Date of birth ___-___-_____ (mm-dd-yyyy)

2. Age at menarche_____(Years of age)

3. Menopausal Statuso Pre-menopausalo Peri-menopausal (last menses < 1 yr ago)o Post-menopausal (last menses > 1 yr ago)

Date of last menstrual period MON / YEAR

ORAge at menopause _____

o Unknown

3A. Surgical Hysterectomy

o No (If no, skip to Q# 4)o Yes

Date of hysterectomy: ___-___-_____ (mm-dd-yyyy)

Date of last menstrual period MON / YEAR

OR Age at menopause ______

4. Hormone Use (If age is unknown code 99, if duration of months is unknown code 999)

o No (If no, skip to Q# 5)o Yes

_____ Birth Control (N/Y/U) (N=No; Y=Yes; U=Unknown)Age at first use ____Duration of use (months)_____

_____ Estrogen Replacement Therapy (N/Y/U)Age at first use ____Duration of use (months) _____

_____ Tamoxifen or Raloxifene (N/Y/U)Age at first use ____Duration of use (months)_____

_____ Fertility Drugs (N/Y/U)Age at first use ____Duration of use (months)_____

5. Full Term PregnanciesNo (If no, skip to Q# 7)

Yes

Number of full term pregnancies ____Age at first full term pregnancy ____

( if age is unknown, code 99)

6. Breast-feedingNo (If no, skip to Q# 7)

Yes

If any children breast-fed, please provide the following details:Number of children breast-fed _____

Number of months per child # 1 _____Number of months per child #2 _____

Number of months per child #3 _____Number of months per child #4 _____Number of months per child #5 _____

Number of months per child #6 _____Total number of breast-feeding months _____ (If

total numberof breast-feedingmonths isunknown,

code 999)

7. Prior breast biopsyNo (If no, skip to Q# 8)

YesNumber of breast biopsies ____ (If unknown, code 99)

Note: If patient had biopsy of both breasts in oneprocedure, enter data as two separate procedures.

Start with most recent biopsyYear ____

Which breast?Right

LeftDiagnosis

o Malignanto Benigno Unknown

6652 I1 7/02 2 of 4


Patient's I.D. No.


Patient's Name

PLACE LABEL HEREI1

Year ____Which breast?

Right

LeftDiagnosis



Right

Left

Diagnosiso Malignanto Benigno Unknown


Right

LeftDiagnosis


8. Prior breast surgeryNo (If no, go to Q# 9)

YesYear ____

Which breast?Right

Left

BilateralType of surgery

o Lumpectomyo Benigno Malignant (If malignant,

patient is NOT eligible)o Mastectomyo Reduction Mammoplastyo Other, specify ________

9. Family History of breast cancer No

Yes

Unknown

MotherAge at diagnosis _____ (Code 99 for unknown)

Unilateral

Bilateral

Unknown

Daughter

Age at diagnosis _____ (Code 99 for unknown)Unilateral

Bilateral

Unknown

Not Applicable

Daughter


Bilateral

Unknown

Maternal Grandmother


Bilateral

Unknown

Paternal Grandmother


Bilateral

Unknown

Sister


Bilateral

Unknown

Not Applicable

Sister


Bilateral

Unknown

Sister


Bilateral

Unknown

Sister


Bilateral

Unknown

6652 I1 7/02 3 of 4


Patient's I.D. No.


Patient's Name

PLACE LABEL HEREI1

Maternal Aunt

Age at diagnosis _____ (Code 99 forunknown)

Unilateral

Bilateral

Unknown

Maternal Aunt


Unilateral

Bilateral

Unknown

Maternal Aunt


Unilateral

Bilateral

Unknown

Maternal Aunt


Unilateral

Bilateral

Unknown

Paternal Aunt


Unilateral

Bilateral

Unknown

Paternal Aunt


Unilateral

Bilateral

Unknown

Paternal Aunt


Unilateral

Bilateral

Unknown

Paternal Aunt


Unilateral

Bilateral

Unknown

Great-Aunt

Maternal

Paternal

Unknown

Age at diagnosis _____ (Code 99 for unknown) Unilateral

Bilateral

Unknown

Great-Aunt

Maternal

Paternal

Unknown


Bilateral

Unknown

Great-Aunt

Maternal

Paternal

Unknown


Bilateral

Unknown

Great-Aunt

Maternal

Paternal

Unknown


Bilateral

Unknown

Cousin


Bilateral

Unknown

Cousin


Bilateral

Unknown

6652 I1 7/02 4 of 4


Patient's I.D. No.


Patient's Name

PLACE LABEL HEREI1

Cousin


Unilateral

Bilateral

Unknown

Cousin


Unilateral

Bilateral

Unknown

Comments:_________________________________

____________________________________________

___________________________________________________________________________________________________________________________________________________________

Form completed by _________________________________

Date ____-_____-______


6652 IA 1/02 1 of 15


Patient's Name

PLACE LABEL HERE

INSTRUCTIONS: This form is completed by the radiologist who interprets the patient’s film-screen study mammo-gram. A separate form is completed for the film-screen and digital mammography interpretation.


American College of RadiologyImaging NetworkStudy MammographyInterpretation - Film Screen

IA

1. Reader ID (initials) _______

2. Image Presentationo Film-Screen

o GEo Fischero Lorado Siemenso Elscinto Bennetto Mammexo Gendexo Acomao Planmedo Giottoo Instrumentarium

3. Prior Filmso Present with interpretationo Not present with interpretationo Patient does not have prior films

4. Date of Study ___/___/_____ (mm/dd/yyyy)

5. Mammography reviewed is:o Study entry mammogram

6. Density of Breast Parenchymao Almost entirely fato Scattered fibroglandular densitieso Heterogeneously denseo Extremely dense

7. Mammography findings?o No (If no, proceed to Q# 8)o YesRight Breasto Noo YesLeft Breasto Noo Yes

A. Mass(es)o No (If no, proceed to Part B)o Yes

o Multiple benign appearing masseso Clinically relevant masseso Both benign appearing and clinically relevant

masses

Total number of clinically relevant masses(both breasts) ______

Right Breast _____Left Breast _____

Clinically Relevant Mass # ___o Right breasto Left breast

O’Clock Location (Check all that apply)� 1-2� 2-3� 3-4� 4-5� 5-6� 6-7� 7-8� 8-9� 9-10� 10-11� 11-12� 12-1� Axillary tail (Clock-face position and depth not

required)� Subareolar nipple (Clock-face position and depth

not required)� Seen on MLO only : Superior� Seen on MLO only: Inferior� Seen on MLO only: Subareolar� Seen on CC only: Medial� Seen on CC only: Lateral� Seen on CC only: Subareolar

Deptho Anterioro Centralo Posterioro Anterior and centralo Central and posterioro Anterior, central and posterior

Shapeo Roundo Ovalo Lobulatedo Irregular

Margins (check all that apply)� Circumscribed� Microlobulated� Obscured� Indistinct� Spiculated

6652 IA 1/02 2 of 15


Patient's I.D. No.


Patient's Name

PLACE LABEL HEREIA

Densityo Higho Equalo Lowo Fat containing

Associated Features (Check all that apply)� Calcifications� Architectural distortions� Skin thickening� Solitary dilated duct� Multiple dilated ducts� None

Size (in mm) of largest dimension _________

How confident are you that this person should becalled back for this abnormality?o There is NO evidence that the patient should be

called back for diagnostic work-up.o There is SOME evidence that the patient should be

called back for diagnostic work-up.o There is SUFFICIENT evidence that the patient

should be called back for diagnostic work-up.o There is STRONG evidence that the patient should

be called back for diagnostic work-up.o There is OVERWHELMING evidence that the

patient should be called back for diagnostic work-up.

Malignancy Scale (for this mass only)o This finding is definitely not malignanto This finding is almost certainly not malignanto This finding is probably not malignanto This finding is possibly malignanto This finding is probably Malignanto This finding is almost certainly malignanto This finding is definitely malignant

Confidence Scale____% Probability of Malignancy (0-100%)

Any additional clinically relevant masseso No (If no, go to Part B)o Yes










6652 IA 1/02 3 of 15


Patient's I.D. No.


Patient's Name

PLACE LABEL HEREIA



called back for diagnostic work-up.o There is SOME evidence that the patient should

be called back for diagnostic work-up.o There is SUFFICIENT evidence that the patient

should be called back for diagnostic work-up.o There is STRONG evidence that the patient

should be called back for diagnostic work-up.o There is OVERWHELMING evidence that the

patient should be called back for diagnosticwork-up.

Malignancy Scale (for this mass only)o This finding is definitely not malignanto This finding is almost certainly not malignanto This finding is probably not malignanto This finding is possibly malignanto This finding is probably malignanto This finding is almost certainly malignanto This finding is definitely malignant

















be called back for diagnostic work-up.o There is OVERWHELMING evidence that the



6652 IA 1/02 4 of 15


Patient's I.D. No.


Patient's Name

PLACE LABEL HEREIA





















B. Asymmetric Densitieso No (If no, go to Part C)o Yes

Total number of clinically relevant asymmetricdensities_____


6652 IA 1/02 5 of 15


Patient's I.D. No.


Patient's Name

PLACE LABEL HEREIA

Clinically Relevant Asymmetric Density # ____o Right breasto Left breast

O’Clock Location (Check all that apply)� 1-2� 2-3� 3-4� 4-5� 5-6� 6-7� 7-8� 8-9� 9-10� 10-11� 11-12� 12-1� Axillary tail (Clock-face position and depth

not required)� Subareolar nipple (Clock-face position

and depth not required)� Seen on MLO only : Superior� Seen on MLO only: Inferior� Seen on MLO only: Subareolar� Seen on CC only: Medial� Seen on CC only: Lateral� Seen on CC only: Subareolar






called back for diagnostic work-up.o There is SOME evidence that the patient should be

called back for diagnostic work-up.o There is SUFFICIENT evidence that the patient


be called back for diagnostic work-up.o There is OVERWHELMING evidence that the patient

should be called back for diagnostic work-up.

Malignancy Scale (for this asymmetric density only)o This finding is definitely not malignanto This finding is almost certainly not malignanto This finding is probably not malignanto This finding is possibly malignanto This finding is probably malignanto This finding is almost certainly malignanto This finding is definitely malignant

Confidence Scale (for this asymmetric density only)

____% Probability of Malignancy (0-100%)

Any additional clinically relevant asymmetric densities?o No (If no, go to Part C)o Yes


O’Clock Location (Check all that apply)� 1-2� 2-3� 3-4� 4-5� 5-6� 6-7� 7-8� 8-9� 9-10� 10-11� 11-12� 12-1� Axillary tail (Clock-face position and depth

not required)� Subareolar nipple (Clock-face position and

depth not required)� Seen on MLO only : Superior� Seen on MLO only: Inferior� Seen on MLO only: Subareolar� Seen on CC only: Medial� Seen on CC only: Lateral� Seen on CC only: Subareolar

6652 IA 1/02 6 of 15


Patient's I.D. No.


Patient's Name

PLACE LABEL HEREIA

















required)� Subareolar nipple (Clock-face position and depth not

required)� Seen on MLO only : Superior� Seen on MLO only: Inferior� Seen on MLO only: Subareolar� Seen on CC only: Medial� Seen on CC only: Lateral� Seen on CC only: Subareolar


6652 IA 1/02 7 of 15


Patient's I.D. No.


Patient's Name

PLACE LABEL HEREIA






















6652 IA 1/02 8 of 15


Patient's I.D. No.


Patient's Name

PLACE LABEL HEREIA










C. Architectural DistortionAnswer all that apply:o No (If no, go to Part D)o Yes, independent of a mass and not reported else-

where on this form.(Complete the remainder of this section)o Yes, associated with a mass and recorded in Part A. (If

there is no independent architectural distortion toreport, go to Part D.)

Total number of clinically relevant architectural distor-tions (both breasts)_____


Clinically Relevant Architectural Distortion # ____

o Right Breasto Left Breast












6652 IA 1/02 9 of 15


Patient's I.D. No.


Patient's Name

PLACE LABEL HEREIA

Malignancy Scale (for this architectural distortion only)o This finding is definitely not malignanto This finding is almost certainly not malignanto This finding is probably not malignanto This finding is possibly malignanto This finding is probably malignanto This finding is almost certainly malignanto This finding is definitely malignant

Confidence Scale (for this architectural distortion only)


Any additional clinically relevant architectural distortions?o No (If no, go to Part D)o Yes

Clinically Relevant architectural distortion # ____

o Right breasto Left breast






How confident are you that this person should be called backfor this abnormality?

o There is NO evidence that the patient should becalled back for diagnostic work-up.

o There is SOME evidence that the patient shouldbe called back for diagnostic work-up.

o There is SUFFICIENT evidence that the patientshould be called back for diagnostic work-up.

o There is STRONG evidence that the patientshould be called back for diagnostic work-up.

o There is OVERWHELMING evidence that thepatient should be called back for diagnosticwork-up.


Confidence Scale


6652 IA 1/02 10 of 15


Patient's I.D. No.


Patient's Name

PLACE LABEL HEREIA
















Confidence Scale



Clinically Relevant architectural distortion # ____o Right breasto Left breast





6652 IA 1/02 11 of 15


Patient's I.D. No.


Patient's Name

PLACE LABEL HEREIA









Confidence Scale


D. Clusters of calcificationsAnswer all that apply:

o No (If no, go to Question 8.)o Yes, independent of a mass and not reported else-

where on this form. (Complete the remainder of thissection)

o Yes, associated with a mass and recorded in Part A.(If there are no independent clusters of calcificationsto report, go to Question 8.)

Total number of clinically relevant calcification clusters(both breasts) _____

Right Breast ____Left Breast ____

Clinically Relevant Cluster # ____






Morphology of Calcifications

o Benign Appearingo Skin Calcificationso Vascular Calcificationso Coarse (“Pop-corn Like”)o Large Rod-likeo Roundo Lucent-Centeredo Eggshell or Rimo Milk of Calciumo Sutureo Dystrophico Punctate

o Intermediate Concerno Amorphous or Indistinct

o Higher Probability of Malignancyo Pleomorphic or Heterogenous (Granular)o Fine, Linear or Fine, Linear ,Branching

(Casting)

6652 IA 1/02 12 of 15


Patient's I.D. No.


Patient's Name

PLACE LABEL HEREIA

Number of calcifications in clustero < 5o 6-15o >15

Distributiono Grouped and clusteredo Linearo Segmentalo Regionalo Diffuse/Scattered








Malignancy Scale (for this cluster of calcifications only)o This finding is definitely not malignanto This finding is almost certainly not malignanto This finding is probably not malignanto This finding is possibly malignanto This finding is probably malignanto This finding is almost certainly malignanto This finding is definitely malignant

Confidence Scale


Any additional clinically relevant calcification clusterso No (If no, go to Q# 8)o Yes











(Casting)

6652 IA 1/02 13 of 15


Patient's I.D. No.


Patient's Name

PLACE LABEL HEREIA











Confidence Scale












6652 IA 1/02 14 of 15


Patient's I.D. No.


Patient's Name

PLACE LABEL HEREIA


(Casting)




How confident are you that this person should be called back for this abnormality?





o There is OVERWHELMING evidence that thepatient should be called back for diagnostic work-up.


Confidence Scale









Morphology of Calcificationso Benign Appearing

o Skin Calcificationso Vascular Calcificationso Coarse (“Pop-corn Like”)o Large Rod-likeo Roundo Lucent-Centeredo Eggshell or Rimo Milk of Calciumo Sutureo Dystrophico Punctate


o Higher Probability of Malignancyo Pleomorphic or Heterogenous (Granular)o Fine, Linear or Fine, Linear ,Branching(Casting)


6652 IA 1/02 15 of 15

REVISIONACRIN Study 6652 Case #

Patient's I.D. No.


Patient's Name

PLACE LABEL HEREIA










Confidence Scale


Overall Mammographic Impression

8. How confident are you that this person should be called back for this (these) abnormality(ies)?






9. Malignancy Scale (based on all mammography findings) (For no findings, code definitely not malignant)

o These findings are definitely not malignanto These findings are almost certainly not malignanto These findings are probably not malignanto These findings are possibly malignanto These findings are probably malignanto These findings are almost certainly malignanto These findings are definitely malignant

10. Confidence Scale (based on all mammography findings)


11. Additional Work-up Recommendedo Noneo Ultrasoundo Short-term interval follow-up (3-6 months)o Physical exam by referring physiciano Surgical consultationo Percutaneous biopsy with sonographic or

stereotactic guidanceo Needle-localized open surgical biopsyo Additional mammography viewso Breast MRIo Other, specify: ___________________________

12. BIRADS Category (based on entire exam)o Category 0 Needs additional imagingo Category 1 Negativeo Category 2 Benign Findingo Category 3 Probably Benign Finding - Short

Interval Follow-up Suggestedo Category 4 Suspicious Abnormality - Biopsy

should be consideredo Category 5 Highly Suggestive of Malignancy -

Appropriate Action Should be Taken

COMMENTS___________________________________________________

___________________________________________________

___________________________________________________

___________________________________________________

___________________________________________________

Form completed by: ____________________________

Date ____________-____________-___________

Study Interpretation Date _______-_______-___________ mm dd yyyy


6652 ID 12-5-02 1 of 15

Patient's I.D. No.


Patient's Name

PLACE LABEL HERE

INSTRUCTIONS: This form is completed by the radiologist who interprets the patient’s digital study mammogram.A separate form is completed for the film-screen and digital mammography interpretation.


American College of RadiologyImaging NetworkStudy MammographyInterpretation - Digital

ID


2. Image Presentation and Display Formato Digital

o GE (soft copy)o Fischer (hard and soft copy)o Lorad -CCD (hard copy)o Lorad -Selenia (hard copy)o Fuji (hard copy)

3. Prior Filmso Present with interpretationo Not present with interpretationo Patient does not have prior films

4. Date of Study ___/___/_____ (mm/dd/yyyy)

5. Mammography reviewed is:o Study entry mammogram


7. Mammography findings?o No (If no, proceed to Q# 8)o YesRight Breasto Noo YesLeft Breasto Noo Yes

A. Mass(es)o No (If no, proceed to Part B)o Yeso Multiple benign appearing masseso Clinically relevant masseso Both benign appearing and clinically relevant

masses



Clinically Relevant Mass # ___


O’Clock Location (Check all that apply)q 1-2q 2-3q 3-4q 4-5q 5-6q 6-7q 7-8q 8-9q 9-10q 10-11q 11-12q 12-1q Axillary tail (Clock-face position and depth not

required)q Subareolar nipple (Clock-face position and depth

not required)q Seen on MLO only : Superiorq Seen on MLO only: Inferiorq Seen on MLO only: Subareolarq Seen on CC only: Medialq Seen on CC only: Lateralq Seen on CC only: Subareolar



Margins (check all that apply)q Circumscribedq Microlobulatedq Obscuredq Indistinctq Spiculated


6652 ID 12-5-02 2 of 15


Patient's I.D. No.


Patient's Name

PLACE LABEL HEREID

Associated Features (Check all that apply)q Calcificationsq Architectural distortionsq Skin thickeningq Solitary dilated ductq Multiple dilated ductsq None









Confidence Scale













6652 ID 12-5-02 3 of 15


Patient's I.D. No.


Patient's Name

PLACE LABEL HEREID





























6652 ID 12-5-02 4 of 15


Patient's I.D. No.


Patient's Name

PLACE LABEL HEREID

Confidence Scale





O’Clock Location (Check all that apply)q 1-2q 2-3q 3-4q 4-5q 5-6q 6-7q 7-8q 8-9q 9-10q 10-11q 11-12q 12-1q Axillary tail (Clock-face position and depth

not required)q Subareolar nipple (Clock-face position and

depth not required)q Seen on MLO only : Superiorq Seen on MLO only: Inferiorq Seen on MLO only: Subareolarq Seen on CC only: Medialq Seen on CC only: Lateralq Seen on CC only: Subareolar














Confidence Scale


B. Asymmetric Densitieso No (If no, go to Part C)o Yes



6652 ID 12-5-02 5 of 15


Patient's I.D. No.


Patient's Name

PLACE LABEL HEREID

Clinically Relevant Asymmetric Density # ____



not required)q Subareolar nipple (Clock-face position

and depth not required)q Seen on MLO only : Superiorq Seen on MLO only: Inferiorq Seen on MLO only: Subareolarq Seen on CC only: Medialq Seen on CC only: Lateralq Seen on CC only: Subareolar

















not required)q Subareolar nipple (Clock-face position and


6652 ID 12-5-02 6 of 15


Patient's I.D. No.


Patient's Name

PLACE LABEL HEREID





How confident are you that this person should becalled back for this abnormality?o There is NO evidence that the patient should

be called back for diagnostic work-up.o There is SOME evidence that the patient

should be called back for diagnostic work-up.o There is SUFFICIENT evidence that the patient




Malignancy Scale (for this asymmetric densityonly)o This finding is definitely not malignanto This finding is almost certainly not malignanto This finding is probably not malignanto This finding is possibly malignanto This finding is probably malignanto This finding is almost certainly malignanto This finding is definitely malignant







required)q Subareolar nipple (Clock-face position and



6652 ID 12-5-02 7 of 15


Patient's I.D. No.


Patient's Name

PLACE LABEL HEREID






be called back for diagnostic work-up.o There is SUFFICIENT evidence that the











required)q Subareolar nipple (Clock-face position and






6652 ID 12-5-02 8 of 15


Patient's I.D. No.


Patient's Name

PLACE LABEL HEREID

How confident are you that this person should be calledback for this abnormality?









C. Architectural DistortionAnswer all that apply:o No (If no, go to Part D)o Yes, independent of a mass and not reported else-


o Yes, associated with a mass and recorded in Part A.(If there is no independent architectural distortion toreport, go to Part D.)

Total number of clinically relevant architectural distortions(both breasts)_____


Clinically Relevant Architectural Distortion # ____

o Right Breasto Left Breast













6652 ID 12-5-02 9 of 15


Patient's I.D. No.


Patient's Name

PLACE LABEL HEREID

Confidence Scale (for this architectural distortion only)


















Any additional clinically relevant architectural distortions?

o No (If no, go to Part D)o Yes



6652 ID 12-5-02 10 of 15


Patient's I.D. No.


Patient's Name

PLACE LABEL HEREID













Confidence Scale






required)q Subareolar nipple (Clock-face position and depth not

required)q Seen on MLO only : Superiorq Seen on MLO only: Inferiorq Seen on MLO only: Subareolarq Seen on CC only: Medialq Seen on CC only: Lateralq Seen on CC only: Subareolar



6652 ID 12-5-02 11 of 15


Patient's I.D. No.


Patient's Name

PLACE LABEL HEREID








Confidence Scale


D. Clusters of calcifications Answer all that apply:

o No (If no, go to Question 8.)o Yes, independent of a mass and not reported

elsewhere on this form. (Complete the remainder ofthis section)














(Casting)

6652 ID 12-5-02 12 of 15


Patient's I.D. No.


Patient's Name

PLACE LABEL HEREID




How confident are you that this person should becalled back for this abnormality?o There is NO evidence that the patient should

be called back for diagnostic work-up.o There is SOME evidence that the patient should






Confidence Scale






required)q Subareolar nipple (Clock-face position and depth not

required)q Seen on MLO only : Superiorq Seen on MLO only: Inferiorq Seen on MLO only: Subareolarq Seen on CC only: Medialq Seen on CC only: Lateralq Seen on CC only: Subareolar





o Higher Probability of Malignancyo Pleomorphic or Heterogenous (Granular)o Fine, Linear or Fine, Linear ,Branching (Casting)

6652 ID 12-5-02 13 of 15


Patient's I.D. No.


Patient's Name

PLACE LABEL HEREID











Confidence Scale












6652 ID 12-5-02 14 of 15


Patient's I.D. No.


Patient's Name

PLACE LABEL HEREID


(Casting)











Confidence Scale













(Casting)

6652 ID 12-5-02 15 of 15


Patient's I.D. No.


Patient's Name

PLACE LABEL HEREID








Malignancy Scale (based on all mammography findings) (Forno findings, code definitely not malignant)

o This finding is almost certainly malignanto This finding is definitely malignanto This finding is definitely not malignanto This finding is almost certainly not malignanto This finding is probably not malignanto This finding is possibly malignanto This finding is probably malignant

Confidence Scale (based on all mammography findings)



8. How confident are you that this person should be called back for this (these) abnormality(ies)?








9. Malignancy Scale (based on all mammography findings) (For no findings, code definitely not malignant)

o This finding is definitely not malignanto This finding is almost certainly not malignanto This finding is probably not malignanto This finding is possibly malignanto This finding is probably malignanto This finding is almost certainly not malignanto This finding is definitely malignant

10. Confidence Scale (based on all mammography findings)


11. Additional Work-up Recommendedq Noneq Ultrasoundq Short-term interval follow-up (3-6-months)q Physical exam by referring physicianq Surgical consultationq Percutaneous biopsy with sonographic or

stereotactic guidanceq Needle-localized open surgical biopsyq Additional mammography viewsq Breast MRIq Other, specify _________

12. BIRADS Category (based on entire exam)

o Category 0 Needs additional imaging o Category 1 Negative o Category 2 Benign Finding o Category 3 Probably Benign Finding - Short Interval Follow-up Suggested o Category 4 Suspicious Abnormality - Biopsy should be considered o Category 5 Highly Suggestive of Malignancy - Appropriate Action should be Taken

Comments _____________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________

Form completed by ______________________

Date ________-________-____________



6652 IE 10-2-02 1 of 10


Patient's Name

PLACE LABEL HERE

INSTRUCTIONS: This form is completed by the Study Radiologist who interprets the patient’s short-term interimfolow-up (3-6-9 mo.) or the one year follow-up Film-Screen or Digital Mammogram, 11 mos. or more afterstudy entry with a BIRADS 3, 4, 5. The completed form is submitted to the ACR.


American College of RadiologyImaging NetworkFollow-up Mammogram InterpretationFilm-Screen or Digital

IE


2. Patient Returno No, did not return for short-term interim studyo No, did not return for one-year follow-up mammogramo Yes, continue with form

3. Image Presentationo Film-Screeno Digital

4. Date of Study ___-___-_____ (mm/dd/yyyy)

5. This Form Reports:o One year follow-up mammogram (BIRADS 3, 4 or 5)o Short-term interim (3-6-9 mo.)o Other____________________________________


7. Mammography findingso No (If no, proceed to Q# 8)o Yes, clinical relevant changes to previous reported

findingo Yes, continue with form

Right Breasto Noo Yes

Left Breasto Noo Yes

A. Clinically relevant Mass(es)o No (If no, proceed to Part B)o Yes




O’Clock Location (Check all that apply)o 1-2o 2-3o 3-4o 4-5o 5-6o 6-7o 7-8o 8-9o 9-10o 10-11o 11-12o 12-1o Axillary tail (Clock-face position and depth not

required)o Subareolar nipple (Clock-face position and depth not

required)o Seen on MLO only : Superioro Seen on MLO only: Inferioro Seen on MLO only: Subareolaro Seen on CC only: Medialo Seen on CC only: Lateralo Seen on CC only: Subareolar


Associated Features (Check all that apply)o Calcificationso Architectural distortionso Skin thickeningo Solitary dilated ducto Multiple dilated ductso None



6652 IE 10-2-02 2 of 10


Patient's I.D. No.


Patient's Name

PLACE LABEL HEREIE

Was this mass Biopsied?o No

If No, what was recommended for patient?o 1 year follow upo 6 month follow upo Other Recommendation:_________________o Yes (If yes, submit Biopsy and Pathology forms)




required)o Subareolar nipple (Clock-face position and depth

not required)o Seen on MLO only : Superioro Seen on MLO only: Inferioro Seen on MLO only: Subareolaro Seen on CC only: Medialo Seen on CC only: Lateralo Seen on CC only: Subareolar








Clinically Relevant Mass # ___________o Right breasto Left breast





6652 IE 10-2-02 3 of 10


Patient's I.D. No.


Patient's Name

PLACE LABEL HEREIE

















B. Clinically relevant Asymmetric Densitieso No (If no, go to Part C)o Yes


Right Breast _____ Left Breast _____


6652 IE 10-2-02 4 of 10


Patient's I.D. No.


Patient's Name

PLACE LABEL HEREIE







Was this Abnormality Biopsied?o No














6652 IE 10-2-02 5 of 10


Patient's I.D. No.


Patient's Name

PLACE LABEL HEREIE



















6652 IE 10-2-02 6 of 10


Patient's I.D. No.


Patient's Name

PLACE LABEL HEREIE

C. Clinically relevant Architectural DistortionAnswer all that apply:o No (If no, go to Part D)o Yes, independent of a mass and not reported

elsewhere on this form. (Complete the remainder ofthis section)

o Yes, associated with a mass and recorded in Part A.(If there is no independent architectural distortion toreport, go to Part D.)

Total number of clinically relevant architectural distor-tions (both breasts)_____


Clinically Relevant Architectural Distortion # ____o Right Breasto Left Breast








If No, what was recommended for patient?o 1 year follow upo 6 month follow upo Other Recommendation:_________________

o Yes (If yes, submit Biopsy and Pathology forms)


Clinically Relevant architectural distortions # ____o Right breasto Left breast






Malignancy Scale (for this architectural distortiononly)o This finding is definitely not malignanto This finding is almost certainly not malignanto This finding is probably not malignanto This finding is possibly malignanto This finding is probably malignanto This finding is almost certainly malignanto This finding is definitely malignant

6652 IE 10-2-02 7 of 10


Patient's I.D. No.


Patient's Name

PLACE LABEL HEREIE




















6652 IE 10-2-02 8 of 10


Patient's I.D. No.


Patient's Name

PLACE LABEL HEREIE




D. Clinically relevant Clusters of calcifications

Answer all that apply:o No (If no, go to Question 7.)o Yes, independent of a mass and not reported else-





Clinically Relevant Cluster # ____o Right breasto Left breast






Malignancy Scale (for this cluster of calcificationsonly)o This finding is definitely not malignanto This finding is almost certainly not malignanto This finding is probably not malignanto This finding is possibly malignanto This finding is probably malignanto This finding is almost certainly malignanto This finding is definitely malignant








6652 IE 10-2-02 9 of 10


Patient's I.D. No.


Patient's Name

PLACE LABEL HEREIE





















6652 IE 10-2-02 10 of 10


Patient's I.D. No.


Patient's Name

PLACE LABEL HEREIE




8. Malignancy Scale (based on all mammographyfindings) (For no findings, code definitely notmalignant)o These findings are definitely not malignanto These findings are almost certainly not malignanto These findings are probably not malignanto These findings are possibly malignanto These findings are probably malignanto These findings are almost certainly malignanto These findings are definitely malignant

9. Additional Work-up Recommendedo Noneo Ultrasoundo Short-term interval follow-up (3-6-months)o Physical exam by referring physiciano Surgical consultationo Percutaneous biopsy with sonographic or

stereotactic guidanceo Needle-localized open surgical biopsyo Additional mammography viewso Breast MRIo Other, specify _________

10. BIRADS Category (based on entire exam)o Category 1 Negativeo Category 2 Benign Findingo Category 3 Probably Benign Finding-Short

Interval Follow-up Suggestedo Category 4 Suspicious Abnormality – Biopsy

should be Consideredo Category 5 Highly Suggestive of Malignancy-


11. Was the Biopsy finding visible in retrospect in the priorstudy?

o Yes, both digital and film screeno Yes, digital onlyo Yes, film screen onlyo No, not visible on digital or film screeno Not applicable - no biopsy finding.

Comments______________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________

Form completed by ______________________

Date _______-________-_____________


Malignancy Scale (for this cluster of calcifications)o This finding is definitely not malignanto This finding is almost certainly not malignanto This finding is probably not malignanto This finding is possibly malignanto This finding is probably malignanto This finding is almost certainly malignanto This finding is definitely malignant




6652 IM 3-31-03 1 of 5

Patient's I.D. No.


Patient's Name

PLACE LABEL HERE

INSTRUCTIONS: This form is completed in the event additional imaging work-up is necessary based on findingsseen on a study film-screen, digital mammogram or prior films. The radiologist who interprets the additionalimaging completes the form and submits the form to the ACR.


American College of RadiologyImaging NetworkAdditional Work-UpScreening Study/Prior Films

IM

1. Reader ID (initials) __________

2. Did the patient return for additional work-up( as recommended per screening study)?o No (Patient did not return, sign and date form)o Yes (continue with form)o Prior films available, needs additional imaging

(continue with form)o Prior films available, screening interpretation not

changed (sign and date form, submit prior film date)o Prior films available, screening interpretation changed,

no additional work-up needed (sign and date form,submit prior film date)

3. For which abnormality(ies) was the additional work-uprecommended?

o Mass (If abnormalities were recommended for workup in both breasts, complete an IM form for eachbreast)

o No o Yes o Yes, Associated with architectural distortion o Yes, Associated with calcifications

Breasto Righto Left

O’Clock Location (If multiple masses, check alllocations)o 1-2o 2-3o 3-4o 4-5o 5-6o 6-7o 7-8o 8-9o 9-10o 10-11o 11-12o 12-1o Axillary tail (Clock-face position and depth

not required)o Subareolar nipple (Clock-face position and

depth not required)o Seen on MLO only : Superioro Seen on MLO only: Inferioro Seen on MLO only: Subareolaro Seen on CC only: Medialo Seen on CC only: Lateralo Seen on CC only: Subareolar

A. What exam led to further work-up?o Digitalo Film-Screeno Both digitial and film-screeno Prior films

B. What additional work-up or recommendationsdid the participant receive?

Additional Mammography Viewso Noo Yes

Number of additional views(including repeats) _____Date performed ____/____/______

Additional Imaging Studieso Noo Yes

o Ultrasoundo Unilateral

o Righto Left

o Bilateral

Date performed ____/____/______

o MRIo Unilateral

o Righto Left

o Bilateral

Date performed ___/___/______

Physical Breast Examinationo Noo Yes, by diagnostic radiologisto Yes, by referring physician

Date ____/____/______

(continued on next page)

6652 IM 3-31-03 2 of 5


Patient's I.D. No.


Patient's Name

PLACE LABEL HEREIM

Other Imagingo Noo Yes


Specify __________________________________

o Asymmetric Densityo Noo Yes

(If abnormalities were recommended for work up inboth breasts, complete an IM from for each breast)

Breasto Righto Left

O’Clock Location (If multiple asymmetricdensities, check all locations)o 1-2o 2-3o 3-4o 4-5o 5-6o 6-7o 7-8o 8-9o 9-10o 10-11o 11-12o 12-1o Axillary tail (Clock-face position and depth





Additional Mammography Viewso Noo YesNumber of additional views(including repeats) _____Date performed ____/____/______



o Righto Left

o Bilateral


o MRIo Unilateral

o Righto Left

o Bilateral



Date ____/____/______


Date performed____/____/______

Specify __________________________________

o Architectural Distortion

(If abnormalities were recommended for work upin both breasts, complete an IM from for eachbreast)

o No o Yes o Yes, (Associated with a mass)

(continued on next page)

6652 IM 3-31-03 3 of 5


Patient's I.D. No.


Patient's Name

PLACE LABEL HEREIM

Breasto Righto Left

O’Clock Location (If multiple architecturaldistortion, check all locations)o 1-2o 2-3o 3-4o 4-5o 5-6o 6-7o 7-8o 8-9o 9-10o 10-11o 11-12o 12-1o Axillary tail (Clock-face position and depth








o Righto Left

o Bilateral


o MRIo Unilateral

o Righto Left

o Bilateral



Date ____/____/______

Other Imagingo Noo Yes Date performed ____/____/______

Specify __________________________________

o Cluster of calcifications(If abnormalities were recommended for work up inboth breasts, complete an IM from for each breast)

o Noo Yes

o Yes, (Associated with a mass)

Breasto Righto Left

O’Clock Location (If multiple clusters ofcalcifications, check all locations)

o 1-2o 2-3o 3-4o 4-5o 5-6o 6-7o 7-8o 8-9o 9-10o 10-11o 11-12o 12-1o Axillary tail (Clock-face position and depth



6652 IM 3-31-03 4 of 5


Patient's I.D. No.


Patient's Name

PLACE LABEL HEREIM


B. What additional work-up or recommendations did the participant receive?




o Righto Left

o Bilateral


o MRIo Unilateral

o Righto Left

o Bilateral



Date ____/____/______



Specify __________________________________

4. Malignancy Scale (based on additional imaging)o This finding is definitely not malignanto This finding is almost certainly not malignanto This finding is probably not malignanto This finding is possibly malignanto This finding is probably malignanto This finding is almost certainly malignanto This finding is definitely malignant

5. BIRADS Category (based on additional imaging)o Category 0 Needs additional imagingo Category 1 Negativeo Category 2 Benign Findingo Category 3 Probably Benign Finding-Short

Interval Follow-up Suggestedo Category 4 Suspicious Abnormality – Biopsy

should be Consideredo Category 5 Highly Suggestive of Malignancy-


6. Additional Work-up Recommended:o Noneo 1 year follow-up mammogramo Ultrasoundo Short-term interval follow-up (3-6 mos.)o Physical Exam by referring physiciano Surgical consultationo Percutaneous biopsy with sonographic

or stereotactic guidanceo Needle - localized open surgical biopsyo Additional mammography viewso Breast MRIo Other, specify: ____________________

7. Is Additional "IM" Form needed to report anabnormality (abnormalities) in the other breast?o Noo Yes

Comments_______________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________

Form completed by ________________________

Date ____-____-______

6652 IM 3-31-03 5 of 5


Patient's I.D. No.


Patient's Name

PLACE LABEL HEREIM

Prior Film Study Interpretation Date(*Date prior films were compared to the study entry screening mammogram)

____-____-________mm dd yyyy

Study Interpretation Date (additional mamography views)

____-____-________mm dd yyyy

Study Interpretation Date (Ultrasound)

____-____-________mm dd yyyy

Study Interpretation Date (other imaging)

____-____-________mm dd yyyy

Study Interpretation Date (MRI)

____-____-________mm dd yyyy

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6652 P4 11-25-02 1 of 3

Patient's I.D. No.


Patient's Name

PLACE LABEL HERE

INSTRUCTIONS: Part A is to be completed by the Research Associate. After completion of part A, the form is sent tothe Core Pathologist for completion of part B. Part B will be completed by the Core Pathologist based on thepathologic material available. The completed form is submitted to the ACR. A separate form is submitted foreach lesion.


American College of RadiologyImaging NetworkCore Pathology Interpretation

Part A (completed by site Research Associate)

1. Procedure Date ___/___/_____ (mm/dd/yyyy)

2. Type of Procedureo FNAo Core Needle Biopsyo Needle localization excisiono Lumpectomyo Mastectomyo Excision by palpationo Other (specify) _________________________________

3. Lesion #____ of # ____

4. Site of biopsyo Righto Left

5. Location (O’clock) (check all that apply)o 1-2o 2-3o 3-4o 4-5o 5-6o 6-7o 7-8o 8-9o 9-10o 10-11o 11-12o 12-1o Axillary tailo Subareolar nipple


6. Specimen ID # ___________

7. Slide ID # _____________

Completed by ______________________________________

Date Sent ___-___-____

P 4

Part B ( completed by the Core Pathologist)

1. Cytopathology (If no, go to Q 3)o Noo Yeso Not applicable

2. Interpretation by Cytopathologisto Insufficient sampleo Benigno Atypicalo Probably malignanto Malignanto Unable to be determined (not related to insufficient

sample)

Lesion Subclassificationo Not applicable (insufficient sample)o Normal/atrophic/mild duct hyperplasiao Fibroadenomao Cysto Apocrine metaplasiao Duct ectasiao Fat necrosiso Duct hyperplasia, mod. or florido Intraductal papillomao Sclerosing adenosiso Radial scaro Lobular neoplasia (ALH,LCIS)o ADHo Low grade DCIS (including cribriform and

micropapillary DCIS)o Carcinoma

o Ductalo Lobularo Mixedo Unclassified

o Unable to be determined (not related to insufficientsample)

o Other, specify ___________

Tumor Gradeo Not applicableo Lowo Moderateo Higho Indeterminate

3. Histologyo Noo Yeso Not applicable

6652 P4 11-25-02 2 of 3


Patient's I.D. No.


Patient's Name

PLACE LABEL HEREP4

o Nippleo Paget’s disease, NOSo Paget’s disease with intraductal carcinomao Paget’s disease with invasive ductal carcinomao Other, specify _________________________ o Other

o Undifferentiated carcinoma o Other, specify _________________________

o Inadequate o Inadequate sample, specify reason __________

5. Calcifications o Not Applicable o No o Yes (Code all that apply)

o Benign, atypical, NOS o ALH o ADH o LCIS o DCIS o Invasive

6. Specimen Size (largest diameter in mm) _______ mm

7. TNM Stage

T Stage (Primary Tumor)o TX Primary tumor cannot be assessed, specify

reason why T-stage unable to be assessed____________________________________

o T0 No evidence of primary tumoro Tis Carcinoma in situ; intraductal carcinoma,

lobular carcinoma in situ, or Paget’s disease ofthe nipple with no tumor

o T1 Tumor 2cm or less in greatest dimensiono T1mic Microinvasion 0.1 cm or less in greatest dimensiono T1a Tumor more than 0.1cm but not more than 0.5 cm

in greatest dimensiono T1b Tumor more than 0.5 cm but not more than 1cm in

greatest dimensiono T1c Tumor more than 1cm but not more than 2cm in

greatest dimensiono T2 Tumor more than 2cm but not more than 5cm in

greatest dimensiono T3 Tumor more than 5cm in greatest dimensiono T4 Tumor of any size with direct extension to (a) chest

wall or (b) skin, only as described belowo T4a Extension to the chest wallo T4b Edema (including peau d’ orange) or ulceration of

the skin of the breast or satellite skin nodulesconfined to the same breast

o T4c Both (T4a and T4b)o T4d Inflammatory carcinoma

Note: Paget’s disease associated with a tumor is classifiedaccording to the size of the tumor.

4. Interpretation of Histology ReportBenign o Not Applicableo Normal/Atrophic/Mild ductal hyperplasiao Fibroadenomao Cyst(s)o Apocrine metaplasiao Duct ectasiao Fat necrosiso Ductal hyperplasia, mod. or florido Intraductal papillomao Sclerosing adenosiso Radial scaro Other, specify __________

Atypical/ Intermediate o Not Applicableo ALHo LCISo ADHo DCIS – low grade

Positiveo Not Applicableo Carcinoma, NOSo Ductal

o Intraductal (in situ)Gradeo Lowo Moderateo Higho IndeterminateNecrosiso Presento Absenceo Not specifiedPatterno Solido Cribriformo Comedoo Micropapillaryo Not specifiedo Other,specify ____________

o Invasive with predominant intraductal componento Invasive, NOSo Comedoo Inflammatoryo Medullary with lymphocytic infiltrateo Mucinous (colloid)o Papillaryo Scirrhouso Tubularo Associated with DCISo Other, specify ______

o Lobularo Invasive with predominant in situ componento Invasiveo Associated with DCISo Other, specify _________________________

6652 P4 11-25-02 3 of 3


Patient's I.D. No.


Patient's Name

PLACE LABEL HEREP4

N Stage (Regional Lymph Nodes)o NX Regional lymph nodes cannot be assessed

(e.g., previously removed)o N0 No regional lymph nodes metastasiso N1 Metastasis to movable ipsilateral lymph node(s)o N2 Metastasis to ipsilateral axillary lymph node(s) fixed

to one another or other structureso N3 Metastasis to ipsilateral internal mammary lymph

node(s)

M Stage (Distant Metastasis)o MX Presence of distant metastasis cannot be assessedo M0 No distant metastasiso M1 Distant metastasis (Includes metastasis to ipsilateral

supraclavicular lymph nodes (s))

8. Agree with local diagnosiso Noo Yes

9. Second opinion needed (If 1st consultant disagrees with localread)o Noo Yes

Comments:__________________________________________

___________________________________________________

____________________________________________________

_____________________________________________________________________________________

Reviewer Name ______________________

Date Reviewed ______-_____-_______


6652 PL 2-10-03 1 of 3

Patient's I.D. No.


Patient's Name

PLACE LABEL HERE

INSTRUCTIONS: Part A is to be completed by the Research Associate. After completion of part A, the form is sent tothe core pathologist with the cytopathology and histopathology reports, if available. Part B will be completed bythe Core Pathologist based only on the reports made available. The completed form is submitted to the ACR. Aseparate form is submitted for each lesion.


American College of RadiologyImaging NetworkInterpretation of Local Pathology

Part A (completed by the Research Associate)

1. Procedure Date ___/___/_____ (mm/dd/yyyy)

2. Type of Procedureo FNAo Core Needle Biopsyo Needle localization excisiono Excision by palpationo Lumpectomyo Mastectomyo Other, specify_________________________________

3. Lesion #____ of # ____

4. Site of biopsyo Righto Left

5. Location (O’clock) (check all that apply)o 1-2o 2-3o 3-4o 4-5o 5-6o 6-7o 7-8o 8-9o 9-10o 10-11o 11-12o 12-1o Axillary tailo Subareolar nipple


Completed by ______________________________________

Date Sent ___-___-____

PL

Part B ( completed by the Core Pathologist)

1. Cytopathology (If no, go to Q 3)o Noo Yeso Not applicable

2. Interpretation from cytopathology reporto Insufficient sampleo Benigno Atypicalo Probably malignanto Malignanto Unable to be determined (not related to insufficient

sample)

Lesion Subclassificationo Not applicable (insufficient sample)o Normal/atrophic/mild duct hyperplasiao Fibroadenomao Cysto Apocrine metaplasiao Duct ectasiao Fat necrosiso Duct hyperplasia, mod. or florido Intraductal papillomao Sclerosing adenosiso Radial scaro Lobular neoplasia (ALH,LCIS)o ADHo Low grade DCIS (including cribriform and

micropapillary DCIS)o Carcinoma

o Ductalo Lobularo Mixedo Unclassified

o Unable to be determined (not related to insufficientsample)

o Other, specify ___________

Tumor Gradeo Not applicableo Lowo Moderateo Higho Indeterminate

3. Histologyo Noo Yeso Not applicable

6652 PL 2-10-03 2 of 3


Patient's I.D. No.


Patient's Name

PLACE LABEL HEREPL

4. Interpretation from Histology ReportBenign o Not Applicableo Normal/Atrophic/Mild ductal hyperplasiao Fibroadenomao Cyst(s)o Apocrine metaplasiao Duct ectasiao Fat necrosiso Ductal hyperplasia, mod. or florido Intraductal papillomao Sclerosing adenosiso Radial scaro Other, specify __________

Atypical/ Intermediate o Not Applicableo ALHo LCISo ADHo DCIS – low grade

Positiveo Not Applicableo Carcinoma, NOSo Ductal

o Intraductal (in situ)Gradeo Lowo Moderateo Higho IndeterminateNecrosiso Presento Absenceo Not specifiedPatterno Solido Cribriformo Comedoo Micropapillaryo Not specifiedo Other,specify ____________

o Invasive with predominant intraductal componento Invasive, NOSo Comedoo Inflammatoryo Medullary with lymphocytic infiltrateo Mucinous (colloid)o Papillaryo Scirrhouso Tubularo Associated with DCISo Other, specify ______

o Lobularo Invasive with predominant in situ componento Invasiveo Associated with DCISo Other, specify _________________________

o Nippleo Paget’s disease, NOSo Paget’s disease with intraductal carcinomao Paget’s disease with invasive ductal carcinomao Other, specify _________________________ o Other

o Undifferentiated carcinoma o Other, specify _________________________

o Inadequate o Inadequate sample, specify reason __________

5. Calcifications o Not Applicable o No o Yes (Code all that apply)

o Benign, atypical, NOS o ALH o ADH o LCIS o DCIS o Invasive

6. Specimen Size (largest diameter in mm) _______ mm

7. TNM Stage

T Stage (Primary Tumor)o TX Primary tumor cannot be assessed, specify

reason why T-stage unable to be assessed____________________________________

o T0 No evidence of primary tumoro Tis Carcinoma in situ; intraductal carcinoma, lobular

carcinoma in situ, or Paget’s disease of the nipplewith no tumor

o T1 Tumor 2cm or less in greatest dimensiono T1mic Microinvasion 0.1 cm or less in greatest dimensiono T1a Tumor more than 0.1cm but not more than 0.5 cm

in greatest dimensiono T1b Tumor more than 0.5 cm but not more than 1cm in

greatest dimensiono T1c Tumor more than 1cm but not more than 2cm in

greatest dimensiono T2 Tumor more than 2cm but not more than 5cm in

greatest dimensiono T3 Tumor more than 5cm in greatest dimensiono T4 Tumor of any size with direct extension to (a) chest

wall or (b) skin, only as described belowo T4a Extension to the chest wallo T4b Edema (including peau d’ orange) or ulceration of

the skin of the breast or satellite skin nodulesconfined to the same breast

o T4c Both (T4a and T4b)o T4d Inflammatory carcinoma

Note: Paget’s disease associated with a tumor is classifiedaccording to the size of the tumor.

6652 PL 2-10-03 3 of 3


Patient's I.D. No.


Patient's Name

PLACE LABEL HEREPL

N Stage (Regional Lymph Nodes)o NX Regional lymph nodes cannot be assessed

(e.g., previously removed)o N0 No regional lymph nodes metastasiso N1 Metastasis to movable ipsilateral lymph node(s)o N2 Metastasis to ipsilateral axillary lymph node(s) fixed

to one another or other structureso N3 Metastasis to ipsilateral internal mammary

lymph node(s)

M Stage (Distant Metastasis)o MX Presence of distant metastasis cannot be assessedo M0 No distant metastasiso M1 Distant metastasis (Includes metastasis to ipsilateral

supraclavicular lymph nodes (s))

Comments:__________________________________________

___________________________________________________

____________________________________________________

_____________________________________________________________________________________

Reviewer Name ______________________

Date Reviewed ______-_____-_______

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