Cathartic-Free DECT Colonography for Detection of Colonic Polyps

Colonic Polyps Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00587028
• Other study ID #: 981-05
• Secondary ID: R21CA110390
• Status: Terminated
• Phase: N/A
• First received: December 21, 2007
• Last updated: January 20, 2016
• Start date: February 2007
• Est. completion date: December 2008

Study information

• Verified date: January 2016
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 99 Years

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Colonic Polyps

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota
United States	Mayo Clinic	Scottsdale	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

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

External Links

•   Mayo Clinic Clinical Trials