Study Results
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View full resultsBasic Information
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COMPLETED
NA
2600 participants
INTERVENTIONAL
2005-02-28
2010-05-13
Brief Summary
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PURPOSE: This clinical trial is studying how well computed tomographic colonography works in screening healthy participants for colorectal cancer.
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
SCREENING
NONE
Study Groups
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CT Colonography
CT colonography conducted during the same assessment as colonoscopy.
CT Colonography
CT colonography performed for comparison with colonoscopy results performed during the same screening assessment.
Interventions
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CT Colonography
CT colonography performed for comparison with colonoscopy results performed during the same screening assessment.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Aged 50 years or older
* Scheduled for screening colonoscopy
* Participant's signed informed consent
Exclusion Criteria
* 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)
50 Years
ALL
Yes
Sponsors
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National Cancer Institute (NCI)
NIH
American College of Radiology Imaging Network
NETWORK
Responsible Party
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Principal Investigators
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C. Daniel Johnson, MD
Role: STUDY_CHAIR
Mayo Clinic
Locations
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Mayo Clinic Scottsdale
Scottsdale, Arizona, United States
Moores UCSD Cancer Center
La Jolla, California, United States
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, United States
Veterans Affairs Medical Center - San Francisco
San Francisco, California, United States
Invision/Radiology Imaging Associates - Englewood
Englewood, Colorado, United States
Yale Cancer Center
New Haven, Connecticut, United States
University of Chicago Cancer Research Center
Chicago, Illinois, United States
Clinical Radiologists, S.C. at Memorial Medical Center
Springfield, Illinois, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Mayo Clinic Cancer Center
Rochester, Minnesota, United States
Mallinckrodt Institute of Radiology at Washington University Medical Center
St Louis, Missouri, United States
M.D. Anderson Cancer Center at University of Texas
Houston, Texas, United States
Virginia Commonwealth University Massey Cancer Center
Richmond, Virginia, United States
Countries
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References
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Vanness DJ, Knudsen AB, Lansdorp-Vogelaar I, Rutter CM, Gareen IF, Herman BA, Kuntz KM, Zauber AG, van Ballegooijen M, Feuer EJ, Chen MH, Johnson CD. Comparative economic evaluation of data from the ACRIN National CT Colonography Trial with three cancer intervention and surveillance modeling network microsimulations. Radiology. 2011 Nov;261(2):487-98. doi: 10.1148/radiol.11102411. Epub 2011 Aug 3.
Johnson CD, Herman BA, Chen MH, Toledano AY, Heiken JP, Dachman AH, Kuo MD, Menias CO, Siewert B, Cheema JI, Obregon R, Fidler JL, Zimmerman P, Horton KM, Coakley KJ, Iyer RB, Hara AK, Halvorsen RA Jr, Casola G, Yee J, Blevins M, Burgart LJ, Limburg PJ, Gatsonis CA. The National CT Colonography Trial: assessment of accuracy in participants 65 years of age and older. Radiology. 2012 May;263(2):401-8. doi: 10.1148/radiol.12102177. Epub 2012 Feb 23.
Hara AK, Blevins M, Chen MH, Dachman AH, Kuo MD, Menias CO, Siewert B, Cheema JI, Obregon RG, Fidler JL, Zimmerman P, Horton KM, Coakley KJ, Iyer RB, Halvorsen RA Jr, Casola G, Yee J, Herman BA, Johnson CD. ACRIN CT colonography trial: does reader's preference for primary two-dimensional versus primary three-dimensional interpretation affect performance? Radiology. 2011 May;259(2):435-41. doi: 10.1148/radiol.11100250. Epub 2011 Mar 1.
Hara AK, Kuo MD, Blevins M, Chen MH, Yee J, Dachman A, Menias CO, Siewert B, Cheema JI, Obregon RG, Fidler JL, Zimmerman P, Horton KM, Coakley K, Iyer RB, Halvorsen RA Jr, Casola G, Johnson CD. National CT colonography trial (ACRIN 6664): comparison of three full-laxative bowel preparations in more than 2500 average-risk patients. AJR Am J Roentgenol. 2011 May;196(5):1076-82. doi: 10.2214/AJR.10.4334.
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.
Johnson CD, Chen MH, Toledano AY, Heiken JP, Dachman A, Kuo MD, Menias CO, Siewert B, Cheema JI, Obregon RG, Fidler JL, Zimmerman P, Horton KM, Coakley K, Iyer RB, Hara AK, Halvorsen RA Jr, Casola G, Yee J, Herman BA, Burgart LJ, Limburg PJ. Accuracy of CT colonography for detection of large adenomas and cancers. N Engl J Med. 2008 Sep 18;359(12):1207-17. doi: 10.1056/NEJMoa0800996.
Related Links
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Clinical trial summary from the National Cancer Institute's PDQ® database
Other Identifiers
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