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The National CT Colonography Trial (ACRIN6664)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00084929
Recruitment Status : Completed
First Posted : June 11, 2004
Results First Posted : November 16, 2020
Last Update Posted : December 22, 2020
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
American College of Radiology Imaging Network

Brief Summary:

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 or disease Intervention/treatment Phase
Colorectal Cancer Procedure: CT Colonography Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2600 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: The National CT Colonography Trial: Multicenter Assessment of Accuracy for Detection of Large Adenomas and Cancers in a Healthy Screening Population
Study Start Date : February 2005
Actual Primary Completion Date : September 11, 2007
Actual Study Completion Date : May 13, 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Number of Participants With Advanced Adenomas (>=10mm) as Determined by Colonoscopy (Per Patient) [ Time Frame: within 30 days ]

    Pathology results from Colonoscopy performed up to 30 days after a CTC examination were used as the reference standard (RS) for determining the existence of advanced adenomas.

    RS+: Colonoscopy found at least 1 Advanced adenomas >=10mm (as measured at pathology) RS-: No Advanced adenomas >=10mm found by colonoscopy (as measured at pathology)


  2. Number of Participants With Advanced Adenomas (>=9mm) Detected by CT Colonoscopy (Per Patient) [ Time Frame: within 30 days ]

    Pathology results from Colonoscopy performed up to 30 days after a CTC examination were used as the reference standard (RS) for determining the existence of advanced adenomas.

    RS+: Colonoscopy found at least 1 Advanced adenomas >=9mm (as measured at pathology) RS-: No Advanced adenomas >=9mm found by colonoscopy (as measured at pathology)


  3. Number of Participants With Advanced Adenomas (>=8mm) Detected by CT Colonoscopy (Per Patient) [ Time Frame: within 30 days ]

    Pathology results from Colonoscopy performed up to 30 days after a CTC examination were used as the reference standard (RS) for determining the existence of advanced adenomas.

    RS+: Colonoscopy found at least 1 Advanced adenomas >=8mm (as measured at pathology) RS-: No Advanced adenomas >=8mm found by colonoscopy (as measured at pathology)


  4. Number of Participants With Advanced Adenomas (>=7mm) Detected by CT Colonoscopy (Per Patient) [ Time Frame: within 30 days ]

    Pathology results from Colonoscopy performed up to 30 days after a CTC examination were used as the reference standard (RS) for determining the existence of advanced adenomas.

    RS+: Colonoscopy found at least 1 Advanced adenomas >=7mm (as measured at pathology) RS-: No Advanced adenomas >=7mm found by colonoscopy (as measured at pathology)


  5. Number of Participants With Advanced Adenomas (>=6mm) Detected by CT Colonoscopy (Per Patient) [ Time Frame: within 30 days ]

    Pathology results from Colonoscopy performed up to 30 days after a CTC examination were used as the reference standard (RS) for determining the existence of advanced adenomas.

    RS+: Colonoscopy found at least 1 Advanced adenomas >=6mm (as measured at pathology) RS-: No Advanced adenomas >=16mm found by colonoscopy (as measured at pathology)


  6. Number of Participants With Advanced Adenomas (>=5mm) Detected by CT Colonoscopy (Per Patient) [ Time Frame: within 30 days ]

    Pathology results from Colonoscopy performed up to 30 days after a CTC examination were used as the reference standard (RS) for determining the existence of advanced adenomas.

    RS+: Colonoscopy found at least 1 Advanced adenomas >=5mm (as measured at pathology) RS-: No Advanced adenomas >=5mm found by colonoscopy (as measured at pathology)



Secondary Outcome Measures :
  1. Number of Advanced Adenoma or Cancer Lesions (>=10mm) Detected by CT Colonoscopy (Per Lesion) [ Time Frame: within 30 days ]
    Pathology results from Colonoscopy performed up to 30 days after a CTC examination were used as the reference standard for determining the existence of advanced adenomas. CTC lesions needed to be within 2 segments and 50% size of the lesions removed via colonoscopy to be considered "detected"

  2. Number of Advanced Adenoma or Cancer Lesions (>=9mm) Detected by CT Colonoscopy (Per Lesion) [ Time Frame: within 30 days ]
    Pathology results from Colonoscopy performed up to 30 days after a CTC examination were used as the reference standard for determining the existence of advanced adenomas. CTC lesions needed to be within 2 segments and 50% size of the lesions removed via colonoscopy to be considered "detected"

  3. Number of Advanced Adenoma or Cancer Lesions (>=8mm) Detected by CT Colonoscopy (Per Lesion) [ Time Frame: within 30 days ]
    Pathology results from Colonoscopy performed up to 30 days after a CTC examination were used as the reference standard for determining the existence of advanced adenomas. CTC lesions needed to be within 2 segments and 50% size of the lesions removed via colonoscopy to be considered "detected"

  4. Number of Advanced Adenoma or Cancer Lesions (>=7mm) Detected by CT Colonoscopy (Per Lesion) [ Time Frame: within 30 days ]
    Pathology results from Colonoscopy performed up to 30 days after a CTC examination were used as the reference standard for determining the existence of advanced adenomas. CTC lesions needed to be within 2 segments and 50% size of the lesions removed via colonoscopy to be considered "detected"

  5. Number of Advanced Adenoma or Cancer Lesions (>=6mm) Detected by CT Colonoscopy (Per Lesion) [ Time Frame: within 30 days ]
    Pathology results from Colonoscopy performed up to 30 days after a CTC examination were used as the reference standard for determining the existence of advanced adenomas. CTC lesions needed to be within 2 segments and 50% size of the lesions removed via colonoscopy to be considered "detected"

  6. Number of Advanced Adenoma or Cancer Lesions (>=5mm) Detected by CT Colonoscopy (Per Lesion) [ Time Frame: within 30 days ]
    Pathology results from Colonoscopy performed up to 30 days after a CTC examination were used as the reference standard for determining the existence of advanced adenomas. CTC lesions needed to be within 2 segments and 50% size of the lesions removed via colonoscopy to be considered "detected"

  7. Interobserver Sensitivity Variability [ Time Frame: at baseline ]
    Evaluate interobserver variability in Sensitivity (P(T+|D+)) and 95% CI) when interpreting CTC examinations Each study was randomly assigned to be read independently using either a primary 2D search method (conventional 2D image display with 3D endoluminal problem solving), or a primary 3D search method (including the capability of displaying multiplanar 2D) and without prior knowledge of the colonoscopy results. A second trained radiologist of similar skill was assigned to read the images using the other modality Readers were then classified as high performing or not high performing



Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00084929


Locations
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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
Saint 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
National Cancer Institute (NCI)
Investigators
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Study Chair: C. Daniel Johnson, MD Mayo Clinic
Additional Information:
Publications of Results:
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.

Other Publications:
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Responsible Party: American College of Radiology Imaging Network
ClinicalTrials.gov Identifier: NCT00084929    
Other Study ID Numbers: CDR0000367101
ACRIN-6664 ( Other Identifier: CIP )
U01CA079778 ( U.S. NIH Grant/Contract )
U01CA080098 ( U.S. NIH Grant/Contract )
First Posted: June 11, 2004    Key Record Dates
Results First Posted: November 16, 2020
Last Update Posted: December 22, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Researchers may request data from the ACRIN data access committee by reviewing the information at:

https://www.acrin.org/RESEARCHERS/POLICIES/DATAANDIMAGESHARINGPOLICY.aspx


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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by American College of Radiology Imaging Network:
colon cancer
rectal cancer
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases