ACRIN 6664 Protocol Review

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ACRIN 6664 Protocol Review

• The National CT Colonography Trial

Name(s) of presenters
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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

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Study Support cont.

• Site Principal Investigator
• Name and contact information
• Site Research Associate
• Name and contact information
• Participating Gastroenterologists
• Name and contact information

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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

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Protocol Review

• Objectives
• Study Design Summary
• Participant Eligibility
• General Study Information
• Recruitment

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Main Objective

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

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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

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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.

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Eligibility

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

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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
• Positive FOBT

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CT Colonography

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

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CTC Images
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Colonoscopy

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

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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

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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)

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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

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Recruitment

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

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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

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Recruitment Tools

• Patient Brochures
• Posters
• Letter to patients

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The National CT Colonoscopy Trial

• Questions

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The National CT Colonoscopy Trial
Thank you!