The National CT Colonography Trial (ACRIN6664)
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ClinicalTrials.gov Identifier: NCT00084929 |
Recruitment Status :
Completed
First Posted : June 11, 2004
Results First Posted : November 16, 2020
Last Update Posted : December 22, 2020
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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 |
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Colorectal Cancer | Procedure: CT Colonography | Not Applicable |
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.
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 |
Arm | Intervention/treatment |
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Experimental: CT Colonography
CT colonography conducted during the same assessment as colonoscopy.
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Procedure: CT Colonography
CT colonography performed for comparison with colonoscopy results performed during the same screening assessment.
Other Names:
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- 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)
- 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)
- 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)
- 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)
- 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)
- 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)
- 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"
- 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"
- 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"
- 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"
- 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"
- 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"
- 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

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.
Ages Eligible for Study: | 50 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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Inclusion Criteria
- Male or female outpatients
- Aged 50 years or older
- Scheduled for screening colonoscopy
- Participant's signed informed consent
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Exclusion Criteria
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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)
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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
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 |
Study Chair: | C. Daniel Johnson, MD | Mayo Clinic |
Publications of Results:
Other Publications:
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
colon cancer rectal cancer |
Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms |
Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases |