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Completed

NCT Number: NCT01200303

Evaluation of Computer-assisted, Non-cathartic CT Colonography

The purpose of this study is to evaluate the performance of a non-cathartic, computer-assisted form of CT Colonography (Virtual Colonoscopy) for detection of pre-cancerous colon polyps in a group of asymptomatic screening patients.

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Key information

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

UCSF-VA Medical Center, San Francisco, California, United States

Loading trial locations.

About this study

Examinations to completely assess the colonic anatomy for the purposes of polyp detection and cancer prevention all require an unpleasant, pre-exam cathartic bowel preparation. The discomfort and embarrassment associated with this bowel prep has been identified as a barrier to adherence of at-risk subjects with recommended colon screening guidelines. CT Colonography (CTC) is an imaging based test that evaluates the entire colon anatomy and requires cathartic bowel prep; its performance is considered comparable to optical colonoscopy (OC) for adenomatous polyp detection. In addition, CTC generates a large amount of data to be read by a human, and this data interpretation task can be aided by computer-assisted-detection (CAD) software to identify potential polyp lesions for the human reviewer. This trial studies the performance of a form of CTC that uses fecal tagging and electronic image cleansing to obviate the need for cathartic prep. In addition, readings prospectively employ CAD to potentially buffer human interpretation performance. The investigators are prospectively testing this augmented (non-cathartic, CAD-assisted) form of CTC in asymptomatic (screening) cohort. The trial is a prospective test comparison, using segmentally unblinded optical colonoscopy in combination with pathology specimens as a reference standard for presence of target lesions, adenomatous polyps 6 mm or greater in size.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • age 50-80, eligible for colon screening

Exclusion criteria

  • prior anatomic colon screening exam (optical colonoscopy, sigmoidoscopy, barium enema, CT Colonography) within last 5 years
  • personal history of inflammatory bowel disease, polyposis syndrome, colo-rectal cancer, colon surgery
  • documented passage of blood per rectum within last 12 months

Treatment and study plan

non-cathartic CTC

Procedure

non-cathartic, CAD-assisted CT Colonography

Other names: tagging of non-cathartic CTC employs iohexol (Omnipaque 300)

Primary outcomes

  1. Performance for detection of adenomatous colonic polyps > 6mm

    Time frame: on per subject basis, metric will be assessed at unblinding OC (w/i 5 weeks enrollment); for cohort, summary statistics will be generated at study completion

    this is a prospective test comparison of non-cathartic, CAD-assisted CT Colonography to segmentally unblinded optical colonoscopy (OC), latter serving with pathology specimens as reference standard for presence of polyps.

Secondary outcomes

  1. Patient comfort associated with non-cathartic exam preparation

    Time frame: on per subject basis, outcome will be assessed at 5 weeks post enrollment (following OC); for cohort, summary statistics will be generated at study completion

    as part of the prospective test comparison, we are generating summary statistics of self-reported patient comfort assessments with the test (non-cathartic) exam preparation versus standard, cathartic preparation.

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • American Cancer Society, Inc.
  • GE Healthcare

Registry information

Official study title

Prospective Evaluation of Computer-Assisted, Non-Cathartic CT Colonography for Detection of Adenomatous Colonic Polyps in a Screening Cohort

Acronym: ncCTC

Important dates

Study start
2005
Primary completion
2010
Study completion
2011
First posted
Sep 13, 2010
Registry last updated
Aug 5, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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