ACRIN 6664 – Protocol Review

1. ACRIN 6664 – Protocol Review The National CT Colonography Trial Name(s) of presenters

2. 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

3. Study Support cont. • Site Principal Investigator • Name and contact information • Site Research Associate • Name and contact information • Participating Gastroenterologists • Name and contact information

4. Rationale • Colorectal cancer • 3rd most common cancer • 2nd 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

5. Protocol Review • Objectives • Study Design Summary • Participant Eligibility • General Study Information • Recruitment

6. Main Objective To clinically validate the widespread use of computerized tomographic colonography (CTC) in a screening population for the detection of colorectal neoplasia.

7. 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

8. 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.

9. Eligibility • Inclusion Criteria • Male or female outpatients • 50 years of age or older • Scheduled for screening colonoscopy • Signed informed consent

10. 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

11. CT Colonography • Interpretation • Radiologists received training • Passed certifying exam in CTC interpretation • Record of findings • Location: segment • Size (mm) • Confidence • Extracolonic findings

12. CTC Images

13. Colonoscopy • Colonoscopy by staff endoscopists • Photographs • All lesions • ICV or appendiceal orifice • Measurement • Calibrated wire or open forceps • Separate container, each specimen

14. 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

15. 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)

16. 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

17. Recruitment • 2289 outpatients • 15 institutions • Accrual goal: maximum 1 year • Approximately 150 patients per site • Quick recruitment is key – rapidly changing technology

18. 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

19. Recruitment Tools • Patient Brochures • Posters • Letter to patients

20. The National CT Colonoscopy Trial Questions

21. The National CT Colonoscopy Trial Thank you!