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American College of Radiology Imaging Network ACRIN 6664 ACRIN 6664 Protocol Review The National CT Colonography Trial Name(s) of presenters Slide 2 American College of Radiology Imaging Network ACRIN 6664 Study Support Funded by: The National Cancer Institute Coordinated by: The American College of Radiology Imaging Network (ACRIN) Trial Principal Investigator: C. Daniel Johnson, MD, Mayo Clinic Endorsed by: The American Cancer Society Slide 3 American College of Radiology Imaging Network ACRIN 6664 Study Support cont. Site Principal Investigator Name and contact information Site Research Associate Name and contact information Participating Gastroenterologists Name and contact information Slide 4 American College of Radiology Imaging Network ACRIN 6664 Rationale Colorectal cancer 3rd most common cancer 2 nd leading cause of malignant death in the US Potential to remove CRC screening barriers Get more people 50 and older screened Save more lives Conflicting evidence exists as to the role of CTC compared to colonoscopy for screening Trial is designed to answer this and other pertinent CTC questions Slide 5 American College of Radiology Imaging Network ACRIN 6664 Protocol Review Objectives Study Design Summary Participant Eligibility General Study Information Recruitment Slide 6 American College of Radiology Imaging Network ACRIN 6664 Main Objective To clinically validate the widespread use of computerized tomographic colonography (CTC) in a screening population for the detection of colorectal neoplasia. To clinically validate the widespread use of computerized tomographic colonography (CTC) in a screening population for the detection of colorectal neoplasia. Slide 7 American College of Radiology Imaging Network ACRIN 6664 Study Design Summary Participants will have a CTC followed by a colonoscopy on the same day. The study addresses important clinical CTC applications: Comparison of the CTC, in a blinded fashion, to colonoscopy Optimization of the CTC technique using new technology Slide 8 American College of Radiology Imaging Network ACRIN 6664 Study Design Summary cont. Optimization of lesion detection by studying the lesions morphological features and developing a computer-assisted diagnosis database Evaluation of patient preferences and their corresponding cost-effectiveness implications. Slide 9 American College of Radiology Imaging Network ACRIN 6664 Eligibility Inclusion Criteria Male or female outpatients 50 years of age or older Scheduled for screening colonoscopy Signed informed consent Slide 10 American College of Radiology Imaging Network ACRIN 6664 Eligibility cont. Exclusion Criteria GI symptoms: blood in stool >1 occasion within 6 months IBD FAP Medical condition increased risk of colonoscopy/no screening benefit Pregnancy Prior colonoscopy in past 5 years Anemia (HGB < 10 gm/dl) Positive FOBT Slide 11 American College of Radiology Imaging Network ACRIN 6664 CT Colonography Interpretation Radiologists received training Passed certifying exam in CTC interpretation Record of findings Location: segment Size (mm) Confidence Extracolonic findings Slide 12 American College of Radiology Imaging Network ACRIN 6664 CTC Images Slide 13 American College of Radiology Imaging Network ACRIN 6664 Colonoscopy Colonoscopy by staff endoscopists Photographs All lesions ICV or appendiceal orifice Measurement Calibrated wire or open forceps Separate container, each specimen Slide 14 American College of Radiology Imaging Network ACRIN 6664 Pathology All lesions > 5 mm read locally and sent for central review Local path for size Slides and tissue block mailed Returned within 30 days Slide 15 American College of Radiology Imaging Network ACRIN 6664 Lesion Matching Independent radiologist Match Same or adjacent segment Within 50% reported size Non-match Location mismatch, within 2 segments- picture comparison (morph & fold location) Size mismatch, location match-picture comparison (morph & fold location) Slide 16 American College of Radiology Imaging Network ACRIN 6664 Participant Considerations Both OC & CTC have advantages & disadvantages Both are likely better at detection/screening Participant Considerations CTC is free to study participant Low radiation dose Extracolonic evaluation for AAA, solid masses, adenopathy Single participant preparation in vast majority Only approx. 1.5 hour extra time needed for study participation Slide 17 American College of Radiology Imaging Network ACRIN 6664 Recruitment 2289 outpatients 15 institutions Accrual goal: maximum 1 year Approximately 150 patients per site Quick recruitment is key rapidly changing technology Slide 18 American College of Radiology Imaging Network ACRIN 6664 Recruitment cont. Patients prescheduled for screening colonoscopy 50 yrs older No prior colonoscopy 5 yrs Patient education Referral by PCP physician very effective Minority recruitment Goal to have solid minority representation Slide 19 American College of Radiology Imaging Network ACRIN 6664 Recruitment Tools Patient Brochures Posters Letter to patients Slide 20 American College of Radiology Imaging Network ACRIN 6664 The National CT Colonoscopy Trial Questions Slide 21 American College of Radiology Imaging Network ACRIN 6664 The National CT Colonoscopy Trial Thank you!