Magnetic Resonance (MR) Colonography With Fecal Tagging

Colorectal Cancer Clinical Trial

Official title:

MR Colonography With Fecal Tagging: A Prospective, Randomized Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00114842
• Other study ID #: KA05029-MA
• Secondary ID: KA05029
• Status: Completed
• Phase: Phase 4
• First received: June 17, 2005
• Last updated: September 19, 2007
• Start date: March 2006
• Est. completion date: March 2007

Study information

• Verified date: September 2007
• Source: Herlev Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: National Board of Health
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine if MR colonography with fecal tagging is better using air or water for distension of the colon. Patients referred to colonoscopy are offered MR colonography before colonoscopy. Two days before colonography, patients ingest a 200 ml Barium sulfate solution 2% four times a day, which will render fecal masses "invisible" on the following MR colonography. Air or water (randomised trial) is used for distension of the colon. The examinations are evaluated by two independent blinded readers.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Suspicion of colorectal polyps or cancer

• Referred for colonoscopy

Exclusion Criteria:

• Suspicion of IBD

• Pacemaker

• Metal in the body

• Claustrophobia

• Pregnancy

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms
• Polyps

Intervention

Procedure:
• MR colonography

Locations

Country	Name	City	State
Denmark	Department of Radiology Copenhagen University Hospital Herlev	Herlev

Sponsors (2)

Lead Sponsor	Collaborator
Herlev Hospital	University Hospital, Gentofte, Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity/specificity for water versus air for distension of colon in MR colonography
Secondary	Feasibility of MR colonography with fecal tagging
Secondary	Sensitivity/specificity of MR colonography versus colonoscopy