Cathartic-Free Dual Energy Computerized Tomography (DECT) Colonography.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Colonic Polyps
- Sponsor
- Mayo Clinic
- Enrollment
- 12
- Locations
- 1
- Primary Endpoint
- Clinical performance of dual-energy CT colonography (CTC).
- Status
- Terminated
- Last Updated
- 10 years ago
Overview
Brief Summary
Asses the clinical performance of dual-energy CTC for the detection of larger polyps 1 cm or larger without cathartic preparation.
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.
Investigators
Jeff Fidler
Principal Investigator
Mayo Clinic
Eligibility 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 chronic obstructive pulmonary disease (COPD) or chronic obstructive lung disease (COLD).
- •Iodine contrast allergy.
Outcomes
Primary Outcomes
Clinical performance of dual-energy CT colonography (CTC).
Time Frame: Three Months
Detection of polyps in cathartic-free CTC using optimized dual-energy techniques.