Recruiting

Observational Study

Sponsor:

Center for Diagnostic Imaging

Code:

NCT00124163

Conditions

Colon Cancer

Polyps

Eligibility Criteria

Sex: All

Age: 45 - 70+

Healthy Volunteers: Accepted

Interventions

Imaging procedure of CT colonography

Study Details

Brief summary:

Computed tomography (CT) colonography has gained widespread multi-disciplinary interest as an evolving noninvasive colorectal screening examination, with the potential of improved patient compliance. The investigator's prior work demonstrated that the bowel preparation was the least tolerable aspect of colorectal evaluation when compared to the CT colonography and optical colonoscopy procedures. Stool tagging could provide a more gentle and efficient bowel preparation, with fewer false positives due to retained stool-mimicking polyps.

The researchers hypothesize that image quality and patient preference will vary with stool tagging concentration and dosing schedule. The researchers propose to evaluate specific stool tagging protocols with the following aims:

AIM 1: Perform a randomized trial of three specific stool tagging protocols using barium and iodine at CT colonography in a well-characterized cohort of patients undergoing colorectal evaluation.

AIM 2: Analyze the CT colonography and optical colonoscopy data to assess differences across stool tagging protocols for the outcome measures of patient preference, image quality in the presence of tagging, and diagnostic reader performance.

The researchers will use specific variations in stool tagging techniques to determine the best image quality of CT data (e.g., homogenous tagging of fluid and stool), and highest patient acceptability, as well as evaluate the adequacy of preparation for same-day colonoscopy. Diagnostic reader performance will focus on the accuracy for detecting all neoplastic lesions including colon cancers, adenomatous polyps, sessile adenomas and flat adenomas. Most importantly, these results will help inform the design of a larger trial of an optimized CT colonography technique in a community setting.

Conditions

Colon Cancer

Polyps

Study ID

NCT00124163

Start date

Jul, 2005

Status verified date

Jan, 2006

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 45 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Patients who are 45 to 80 years old for routine screening colonoscopy

Exclusion Criteria:

  • Patients with inflammatory bowel disease
  • Patients with polyposis syndromes
  • Pregnant women
  • Patients over 350 pounds
  • Patients with bright red blood per rectum
  • Patients who have a contraindication to undergo outpatient colonoscopy, including patients on blood thinners, prior myocardial infarction (MI) in the last six months, history of congestive heart failure (CHF), history of arrhythmia, patients too weak to transfer themselves from a bed to a chair, or patients with severe constipation who would require a two day bowel preparation.

All subjects will undergo informed consent by the St. Luke's institutional review board (IRB). Referred subjects will be asked if they are interested in the study and those responding affirmatively will be transferred to a recruiter to learn about the study and begin the consent process if interested.

Study Design

Enrollment

60 participants

Interventions and Outcome Measures

Interventions

Imaging procedure of CT colonography

Central Contacts and Locations

Central contacts

Elizabeth G. McFarland, MD

636-733-8911McFarlandB@mir.wustl.edu

Elisabeth Quam-Berne

952-525-6308lquam@cdirad.com

Locations

Diagnostic Imaging Associates

Recruiting

Chesterfield, Missouri, United States, 63017

Contacts

Elizabeth G. McFarland, MD

636-733-8911McFarlandB@mir.wustl.edu

Elisabeth Quam-Berne

952-525-6308lquam@cdirad.com

More Information

Sponsor

Center for Diagnostic Imaging

Last update posted

Feb 2, 2006

Last verified

Jan, 2006

Keywords

  • CT Virtual Colonoscopy
  • Optical Colonoscopy
  • Stool Tagging
  • Patient Preparation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Center for Diagnostic Imaging on 2006-02-02.