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

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ClinicalTrials.gov Identifier: NCT00084929

Recruitment Status : Completed

First Posted : June 11, 2004

Last Update Posted : October 8, 2013

Sponsor:

Collaborator:

National Cancer Institute (NCI)

Information provided by (Responsible Party):

American College of Radiology Imaging Network

Study Description

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	Phase 2 Phase 3

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	2607 participants
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Screening
Official Title:	National CT Colonography Trial
Study Start Date :	February 2005
Actual Primary Completion Date :	September 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy Colorectal Cancer

U.S. FDA Resources

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

Sensitivity [ Time Frame: 1 Day ]
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 ]
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 ]
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 ]
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.

Eligibility Criteria

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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

Inclusion Criteria
- Male or female outpatients
- Aged 50 years or older
- Scheduled for screening colonoscopy
- Participant's signed informed consent
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

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
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

National Cancer Institute (NCI)

Investigators

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Study Chair:	C. Daniel Johnson, MD	Mayo Clinic

More Information

Publications of Results:

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. Erratum in: N Engl J Med. 2008 Dec 25;359(26):2853.

Other Publications:

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.

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Responsible Party:	American College of Radiology Imaging Network
ClinicalTrials.gov Identifier:	NCT00084929 History of Changes
Other Study ID Numbers:	CDR0000367101 ACRIN-6664
First Posted:	June 11, 2004 Key Record Dates
Last Update Posted:	October 8, 2013
Last Verified:	October 2013

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

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