Computed Tomographic Colonography in Screening Healthy Participants for Colorectal Cancer - Full Text View

Sponsor:	American College of Radiology Imaging Network
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00084929

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
Colorectal Cancer	Procedure: comparison of screening methods Procedure: computed tomography colonography Procedure: screening colonoscopy

Study Type:	Interventional
Study Design:	Masking: Open Label Primary Purpose: Screening
Official Title:	National CT Colonography Trial

Resource links provided by NLM:

MedlinePlus related topics: Cancer Colonoscopy Colorectal Cancer

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment:	2607
Study Start Date:	February 2005
Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

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

DISEASE CHARACTERISTICS:

Scheduled for screening colonoscopy
- No colonoscopy within the past 5 years
No familial polyposis syndrome

PATIENT CHARACTERISTICS:

Age

50 and over

Performance status

Not specified

Life expectancy

Not specified

Hematopoietic

Hemoglobin ≥ 10 g/dL

Hepatic

Not specified

Renal

Not specified

Gastrointestinal

No symptoms of disease of the lower gastrointestinal tract, including any of the following:
- Melanotic stools and/or hematochezia more than once in the past 6 months
- Lower abdominal pain requiring medical evaluation
No inflammatory bowel disease
Negative fecal occult blood test

Other

Not pregnant
Negative pregnancy test
No serious medical condition that would increase the risk associated with colonoscopy
No serious medical condition that is so severe that screening would have no benefit

PRIOR CONCURRENT THERAPY:

Biologic therapy

Not specified

Chemotherapy

Not specified

Endocrine therapy

Not specified

Radiotherapy

Not specified

Surgery

Not specified

Contacts and Locations

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

National Cancer Institute (NCI)

Investigators

Study Chair:

C. Daniel Johnson, MD

Mayo Clinic

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications:

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. 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.

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.

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 Aug 3; [Epub ahead of print]

ClinicalTrials.gov Identifier:	NCT00084929 History of Changes
Other Study ID Numbers:	CDR0000367101, ACRIN-6664
Study First Received:	June 10, 2004
Last Updated:	August 27, 2011
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

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 May 21, 2012