Cathartic-Free DECT Colonography for Detection of Colonic Polyps

Mayo Clinic

Status: Terminated

Conditions: Colonic Polyps

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT00587028

R21CA110390 (U.S. NIH Grant/Contract)

981-05

Details and patient eligibility

About

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

Full 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.

Enrollment: 12 patients

Sex: All

Ages: 40 to 99 years old

Volunteers: No Healthy Volunteers

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.

Trial design

12 participants in 4 patient groups

Oral Omnipaque MCA

Description:

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

Description:

Ten participant minimum: for intravenous iodine contrast dye. This cohort at Rochester Mayo Clinic only.

NO oral and no IV MCR

Description:

Five participant minimum for no oral or IV contrast.

Replacement Group

Description:

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.