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Computed Tomographic Colonography in Screening Healthy Participants for Colorectal Cancer (ACRIN 6664)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
American College of Radiology Imaging Network
ClinicalTrials.gov Identifier:
NCT00084929
First received: June 10, 2004
Last updated: October 7, 2013
Last verified: October 2013

June 10, 2004
October 7, 2013
February 2005
September 2008   (final data collection date for primary outcome measure)
Sensitivity [ Time Frame: 1 Day ] [ Designated as safety issue: Yes ]
Evaluate the sensitivity of CT colonography for detecting participants with at least one proved clinically significant large lesion (at least 10 mm in diameter), using colonoscopy as the reference standard.
Not Provided
Complete list of historical versions of study NCT00084929 on ClinicalTrials.gov Archive Site
  • Interobserver variation in accuracy [ Time Frame: 1 Day ] [ Designated as safety issue: No ]
    Evaluate interobserver variation in accuracy of interpreting CTC examinations, including any benefits of 1) a primary 3D read and/or 2) independent second interpretations.
  • Additional secondary outcome measures [ Time Frame: 1 Day ] [ Designated as safety issue: No ]
    1. To develop a well-annotated database of CTC case materials for future study. Data appropriate for computed-aided diagnosis development will be collected for this purpose. This data, subject to ACRIN Image Archive policies, will be made available to the image processing and clinical community. Availability of CTC case materials may be via the internet.
    2. To assess the cost-effectiveness of CTC compared to other CRC screening tests.
Not Provided
Descriptive outcomes [ Time Frame: 1 Day ] [ Designated as safety issue: No ]
  1. To describe the effects of different colon preparations, as ordered by the referring gastroenterologist, on accuracy of CTC.
  2. To describe patient acceptance of CT colonography and their willingness to have a repeat examination in comparison to optical colonoscopy.
  3. To describe the various morphologic features, distribution, and frequency of flat colonic lesions, and to estimate the accuracy of CTC in detecting flat lesions in the colon.
  4. To describe the prevalence and clinical significance of extracolonic abnormalities detected in the course of a CTC examination.
  5. To describe the various methods of CTC evaluation and assess differences in software platforms by evaluating user preferences and performance differences, including evaluation times.
Not Provided
 
Computed Tomographic Colonography in Screening Healthy Participants for Colorectal Cancer
National CT Colonography Trial

RATIONALE: New diagnostic procedures such as computed tomographic colonography may improve the ability to detect colorectal cancer and may provide a less invasive method of detection.

PURPOSE: This clinical trial is studying how well computed tomographic colonography works in screening healthy participants for colorectal cancer.

OBJECTIVES:

Primary

  • Compare the sensitivity of computed tomographic colonography (CTC) vs colonoscopy for detecting significantly large lesions (≥ 10 mm in diameter) in asymptomatic participants, in terms of specificity, area under the ROC curve, and predictive values for detecting clinically significant colorectal neoplasia.

Secondary

  • Determine the interobserver variation in accuracy of interpreting CTC examinations of these participants, including any benefits of a primary 3-dimensional read and/or independent second interpretations.
  • Determine the effects of different colon preparations on the accuracy of CTC in these participants.
  • Compare participant acceptance and willingness to have a repeat examination by CTC vs colonoscopy.
  • Determine the accuracy of CTC in detecting flat lesions in the colon of these participants.

OUTLINE: This is a multicenter study.

Participants receive an oral laxative, oral bisacodyl, and three doses of oral barium sulphate 24 hours before imaging. After cathartic cleansing, participants undergo computed tomographic colonography followed by colonoscopy.

Participants are followed up for approximately 4 weeks.

PROJECTED ACCRUAL: A total of 2,607 participants will be accrued for this study.

Interventional
Phase 2
Phase 3
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Screening
Colorectal Cancer
Procedure: CT Colonography
CT colonography performed for comparison with colonoscopy results performed during the same screening assessment.
Other Names:
  • CT colonography trial
  • colonoscopy
Experimental: CT Colonography
CT colonography conducted during the same assessment as colonoscopy.
Intervention: Procedure: CT Colonography

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2607
Not Provided
September 2008   (final data collection date for primary outcome measure)
  1. Inclusion Criteria

    • Male or female outpatients
    • Aged 50 years or older
    • Scheduled for screening colonoscopy
    • Participant's signed informed consent
  2. Exclusion Criteria

    • Symptoms of disease of the lower gastrointestinal tract, including

      • Melanotic stools or/and hematochezia on more than one occasion in the previous six months
      • Lower abdominal pain that would normally require a medical evaluation
    • Inflammatory bowel disease and/or familial polyposis syndrome
    • Serious medical conditions that would increase the risk associated with colonoscopy or are so severe that screening would have no benefit
    • Pregnancy
    • Previous colonoscopy within the past five years
    • Anemia (hemoglobin less than 10 gm/dl)
    • Positive fecal occult blood test (FOBT)
Both
50 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00084929
CDR0000367101, ACRIN-6664
Yes
American College of Radiology Imaging Network
American College of Radiology Imaging Network
National Cancer Institute (NCI)
Study Chair: C. Daniel Johnson, MD Mayo Clinic
American College of Radiology Imaging Network
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP