Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

Computed Tomographic Colonography in Screening Healthy Participants for Colorectal Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
No phase specified	Screening	Closed	50 and over	NCI	ACRIN-6664 NCT00084929

Objectives

Primary

1. 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

1. 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.
2. Determine the effects of different colon preparations on the accuracy of CTC in these participants.
3. Compare participant acceptance and willingness to have a repeat examination by CTC vs colonoscopy.
4. Determine the accuracy of CTC in detecting flat lesions in the colon of these participants.

Entry Criteria

Disease Characteristics:

• Scheduled for screening colonoscopy
  • No colonoscopy within the past 5 years



• No familial polyposis syndrome

Prior/Concurrent Therapy:

Biologic therapy

• Not specified

Chemotherapy

• Not specified

Endocrine therapy

• Not specified

Radiotherapy

• Not specified

Surgery

• Not specified

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

Expected Enrollment

A total of 2,607 participants will be accrued for this study.

Outline

This is a multicenter study.

Participants receive an oral laxative, oral bisacodyl, and oral barium sulphate 24 hours before imaging. Participants then undergo computed tomographic colonography followed by colonoscopy.

Participants are followed at approximately 4 weeks.

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, et al.: Accuracy of CT colonography for detection of large adenomas and cancers. N Engl J Med 359 (12): 1207-17, 2008.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

American College of Radiology Imaging Network

C. Daniel Johnson, MD, Protocol chair		Ph: 507-284-8550

Registry Information
Official Title		National CT Colonography Trial
Trial Start Date		2005-02-21
Registered in ClinicalTrials.gov		NCT00084929
Date Submitted to PDQ		2004-04-14
Information Last Verified		2006-12-03
NCI Grant/Contract Number		CA080098

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