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
  Purpose

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.


Condition Intervention Phase
Colorectal Cancer
Procedure: CT Colonography
Phase 2
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Screening
Official Title: National CT Colonography Trial

Resource links provided by NLM:


Further study details as provided by American College of Radiology Imaging Network:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Other Outcome Measures:
  • 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.


Enrollment: 2607
Study Start Date: February 2005
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CT Colonography
CT colonography conducted during the same assessment as colonoscopy.
Procedure: CT Colonography
CT colonography performed for comparison with colonoscopy results performed during the same screening assessment.
Other Names:
  • CT colonography trial
  • colonoscopy

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria
  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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00084929

Locations
United States, Arizona
Mayo Clinic Scottsdale
Scottsdale, Arizona, United States, 85259-5499
United States, California
Moores UCSD Cancer Center
La Jolla, California, United States, 92093-0658
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, United States, 90095-1781
Veterans Affairs Medical Center - San Francisco
San Francisco, California, United States, 94121
United States, Colorado
Invision/Radiology Imaging Associates - Englewood
Englewood, Colorado, United States, 80112
United States, Connecticut
Yale Cancer Center
New Haven, Connecticut, United States, 06520-8028
United States, Illinois
University of Chicago Cancer Research Center
Chicago, Illinois, United States, 60637-1470
Clinical Radiologists, S.C. at Memorial Medical Center
Springfield, Illinois, United States, 62781
United States, Maryland
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231-2410
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
United States, Minnesota
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905
United States, Missouri
Mallinckrodt Institute of Radiology at Washington University Medical Center
St. Louis, Missouri, United States, 63110
United States, Texas
M.D. Anderson Cancer Center at University of Texas
Houston, Texas, United States, 77030-4009
United States, Virginia
Virginia Commonwealth University Massey Cancer Center
Richmond, Virginia, United States, 23298-0037
Sponsors and Collaborators
American College of Radiology Imaging Network
Investigators
Study Chair: C. Daniel Johnson, MD Mayo Clinic
  More Information

Additional Information:
Publications:
Siewert B, Gareen I, Vanness D, et al.: ACRIN 6664: patient acceptance and preferance of CT colonography compared to optical colonoscopy for colon cancer screening. [Abstract] J Clin Oncol 27 (Suppl 15): A-4034, 2009.

Responsible Party: American College of Radiology Imaging Network
ClinicalTrials.gov Identifier: NCT00084929     History of Changes
Other Study ID Numbers: CDR0000367101, ACRIN-6664
Study First Received: June 10, 2004
Last Updated: October 7, 2013
Health Authority: United States: Federal Government

Keywords provided by American College of Radiology Imaging Network:
colon cancer
rectal cancer

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on July 23, 2014