Cathartic-Free DECT Colonography for Detection of Colonic Polyps

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00587028
Recruitment Status : Terminated (Administrative closed due to funding)
First Posted : January 7, 2008
Last Update Posted : January 22, 2016
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Jeff Fidler, Mayo Clinic

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

Condition or disease
Colonic Polyps

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.

Study Type : Observational
Actual Enrollment : 12 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cathartic-Free Dual Energy Computerized Tomography (DECT) Colonography.
Study Start Date : February 2007
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonic Polyps
U.S. FDA Resources

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.

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   40 Years to 99 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

Additional Information:
Responsible Party: Jeff Fidler, Principal Investigator, Mayo Clinic Identifier: NCT00587028     History of Changes
Other Study ID Numbers: 981-05
R21CA110390 ( U.S. NIH Grant/Contract )
First Posted: January 7, 2008    Key Record Dates
Last Update Posted: January 22, 2016
Last Verified: January 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Jeff Fidler, Mayo Clinic:
Computed Tomographic Colonography
Large intestine

Additional relevant MeSH terms:
Colonic Polyps
Pathological Conditions, Anatomical
Intestinal Polyps
Gastrointestinal Agents