Cathartic-Free DECT Colonography for Detection of Colonic Polyps
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Cathartic-Free Dual Energy Computerized Tomography (DECT) Colonography.|
- 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.
|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.
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00587028
|United States, Arizona|
|Scottsdale, Arizona, United States, 85259|
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Jeff L. Fidler, M.D.||Mayo Clinic|