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Sponsors and Collaborators: |
Mayo Clinic National Cancer Institute (NCI) |
Information provided by: | Mayo Clinic |
ClinicalTrials.gov Identifier: | NCT00587028 |
Asses the clinical performance of dual-energy CTC for the detection of larger polyps 1 cm or larger without cathartic preparation.
Condition |
Colonic Polyps |
MedlinePlus related topics: | Colonic Polyps |
Study Type: | Observational |
Study Design: | Cohort, Prospective |
Official Title: | Cathartic-Free Dual Energy Computerized Tomography (DECT) Colonography. |
Estimated Enrollment: | 30 |
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.
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2
Ten participant minimum: for intravenous iodine contrast dye. This cohort at Rochester Mayo Clinic only.
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3
Five participant minimum for no oral or IV contrast.
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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.
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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 and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Mayo Clinic, Rochester, Minnesota and Mayo Clinic, Scottsdale, Arizona Colonoscopy schedules.
Inclusion Criteria:
Exclusion Criteria:
United States, Arizona | |||||
Mayo Clinic | |||||
Scottsdale, Arizona, United States, 85259 | |||||
United States, Minnesota | |||||
Mayo Clinic | |||||
Rochester, Minnesota, United States, 55905 |
Mayo Clinic |
National Cancer Institute (NCI) |
Principal Investigator: | Jeff L. Fidler, M.D. | Mayo Clinic |
Mayo Clinic Clinical Trials 
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Responsible Party: | Mayo Clinic ( Jeff L. Fidler, M.D. ) |
Study ID Numbers: | 981-05 |
First Received: | December 21, 2007 |
Last Updated: | May 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00587028 |
Health Authority: | United States: Food and Drug Administration; United States: Institutional Review Board |
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