Cathartic-Free DECT Colonography

This study has been terminated.
(Administrative closed due to funding)
Sponsor:
Collaborator:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00587028
First received: December 21, 2007
Last updated: January 20, 2010
Last verified: January 2010
  Purpose

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


Condition
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:

Enrollment: 12
Study Start Date: July 2005
Estimated Study Completion Date: December 2008
Estimated Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Ten participant minimum: for stool tagging two days preceding the CT colonography, if applicable, with oral Omnipaque. This cohort at Scottsdale Mayo Clinic only.
2
Ten participant minimum: for intravenous iodine contrast dye. This cohort at Rochester Mayo Clinic only.
3
Five participant minimum for no oral or IV contrast.
4
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.

  Eligibility

Ages Eligible for Study:   40 Years and older
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.

Criteria

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 COPD or COLD.
  • Iodine contrast allergy.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00587028

Locations
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
Investigators
Principal Investigator: Jeff L. Fidler, M.D. Mayo Clinic
  More Information

Additional Information:
No publications provided

Responsible Party: Jeff L. Fidler, M.D., Mayo Clinic
ClinicalTrials.gov Identifier: NCT00587028     History of Changes
Other Study ID Numbers: 981-05
Study First Received: December 21, 2007
Last Updated: January 20, 2010
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Mayo Clinic:
Colonography
Colonoscopy
Virtual
Computed Tomographic Colonography
Large intestine
colon

Additional relevant MeSH terms:
Colonic Polyps
Intestinal Polyps
Polyps
Pathological Conditions, Anatomical
Cathartics
Laxatives
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 26, 2014