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Clinical Trials (PDQ®)

Computed Tomographic Colonography in Screening Healthy Participants for Colorectal Cancer

Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase III, Phase IIScreeningCompleted50 and overNCI, OtherCDR0000367101
ACRIN-6664, NCT00084929

Trial Description

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.

Further Study Information

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 Criteria

1. Inclusion Criteria

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

2. 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)

Trial Contact Information

Trial Lead Organizations/Sponsors

American College of Radiology Imaging Network

National Cancer Institute

C. Daniel JohnsonStudy Chair

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00084929
ClinicalTrials.gov processed this data on November 12, 2014

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.

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