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									ACRIN 6664 – Protocol Review


The National CT Colonography Trial


                            Name(s) of presenters




    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

       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


       American College of Radiology Imaging Network   ACRIN 6664
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

       American College of Radiology Imaging Network   ACRIN 6664
Protocol Review
 Objectives

 Study Design Summary

 Participant Eligibility

 General Study Information

 Recruitment

     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.




      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


      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.




       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



     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
     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

       American College of Radiology Imaging Network   ACRIN 6664
CTC Images




   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


     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




      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)


      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


        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


      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



        American College of Radiology Imaging Network   ACRIN 6664
Recruitment Tools
 Patient Brochures


 Posters


 Letter to patients




      American College of Radiology Imaging Network   ACRIN 6664
The National CT Colonoscopy Trial




                         Questions




     American College of Radiology Imaging Network   ACRIN 6664
The National CT Colonoscopy Trial




                 Thank you!



     American College of Radiology Imaging Network   ACRIN 6664

								
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