Cathartic-Free DECT Colonography for Detection of Colonic Polyps

Cathartic-Free Dual Energy Computerized Tomography (DECT) Colonography.

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00587028

Enrollment

Registered

2008-01-07

Start date

2007-02-28

Completion date

2008-12-31

Last updated

2016-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colonic Polyps

Keywords

Colonography, Colonoscopy, Virtual, Computed Tomographic Colonography, Large intestine, colon

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

40 Years to 99 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
Clinical performance of dual-energy CT colonography (CTC).	Three Months	Detection of polyps in cathartic-free CTC using optimized dual-energy techniques.

Countries

United States

Outcome results