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Cathartic-Free DECT Colonography for Detection of Colonic Polyps

This study has been terminated.
(Administrative closed due to funding)
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Jeff Fidler, Mayo Clinic Identifier:
First received: December 21, 2007
Last updated: January 20, 2016
Last verified: January 2016
Asses the clinical performance of dual-energy CTC for the detection of larger polyps 1 cm or larger without cathartic preparation.

Colonic Polyps

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cathartic-Free Dual Energy Computerized Tomography (DECT) Colonography.

Resource links provided by NLM:

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Clinical performance of dual-energy CT colonography (CTC). [ Time Frame: Three Months ] [ Designated as safety issue: Yes ]
    Detection of polyps in cathartic-free CTC using optimized dual-energy techniques.

Enrollment: 12
Study Start Date: February 2007
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Oral Omnipaque MCA
Ten participant minimum: for stool tagging two days preceding the CT colonography, if applicable, with oral Omnipaque. This cohort at Scottsdale Mayo Clinic only.
IV Iodine MCR
Ten participant minimum: for intravenous iodine contrast dye. This cohort at Rochester Mayo Clinic only.
NO oral and no IV MCR
Five participant minimum for no oral or IV contrast.
Replacement Group
Five participant minimum for either cohorts 1, 2, or 3 as above should there be poor imaging results. A like prepped participant will replace that who had poor quality imaging to meet 25 imaging data sets.

Detailed Description:

Determine the feasibility to differentiate polyps from stool with or without the use of contrast agents and to assess the feasibility and accuracy of dual energy techniques in a pilot patient study.

1.1 Formulate algorithms that use dual-energy information to quantitatively measure specific material density of colon polyps in physics based simulation.

1.2 Determine optimal scanning parameters on prototype CT equipment.

2.1 Measure the material composition density and Hounsfield number of polyps with and without simulated contrast enhancement.

2.2 Measure the accuracy of dual-energy techniques to differentiate between polyps and stool and if needed using a combination of simulated intravenous enhanced polyps and contrast material tagged stool.

3.0 Asses the clinical performance of dual-energy CTC for the detection of larger polyps 1 cm or larger without cathartic preparation.


Ages Eligible for Study:   40 Years to 99 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Mayo Clinic, Rochester, Minnesota and Mayo Clinic, Scottsdale, Arizona Colonoscopy schedules.

Inclusion Criteria:

  • Participants with a known colorectal polyp or colon carcinoma with pathology, at or greater than 1 cm in size on a colonoscopy that is completed either eight weeks before or after CT Colonography study visit.
  • If receiving iodine oral or IV contrast, must have a creatinine less than 1.4 on record within last 30 days of study visit date. If no creatinine is available, one will be drawn for enrollment criteria purposes.

Exclusion Criteria:

  • Pregnant females.
  • Presence of colostomy or right hemicolectomy.
  • Inflammatory bowel disease (Crohn's, chronic ulcerative colitis).
  • Familial polyposis syndrome.
  • Pregnant female.
  • Creatinine at or greater than 1.4
  • Severe or uncontrolled chronic obstructive pulmonary disease (COPD) or chronic obstructive lung disease (COLD).
  • Iodine contrast allergy.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00587028

United States, Arizona
Mayo Clinic
Scottsdale, Arizona, United States, 85259
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
National Cancer Institute (NCI)
Principal Investigator: Jeff L. Fidler, M.D. Mayo Clinic
  More Information

Additional Information:
Responsible Party: Jeff Fidler, Principal Investigator, Mayo Clinic Identifier: NCT00587028     History of Changes
Other Study ID Numbers: 981-05  R21CA110390 
Study First Received: December 21, 2007
Last Updated: January 20, 2016
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Mayo Clinic:
Computed Tomographic Colonography
Large intestine

Additional relevant MeSH terms:
Colonic Polyps
Pathological Conditions, Anatomical
Intestinal Polyps
Gastrointestinal Agents processed this record on October 26, 2016