Magnetic Resonance (MR) Colonography With Fecal Tagging

• Sponsor: Herlev Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT00114842
• Collaborator: University Hospital, Gentofte, Copenhagen (Other)
• Enrollment: 60
• Location: 1
• Duration (Months): 12
• Patients Per Site Per Month: 5

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Colorectal Cancer; Polyps	Procedure: MR colonography	Phase 4

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single
• Primary Purpose: Diagnostic
• Official Title: MR Colonography With Fecal Tagging: A Prospective, Randomized Study
• Study Start Date: Mar 1, 2006
• Actual Study Completion Date: Mar 1, 2007

Outcome Measures

Primary Outcome Measures

1. Sensitivity/specificity for water versus air for distension of colon in MR colonography []

Secondary Outcome Measures

1. Feasibility of MR colonography with fecal tagging []

2. Sensitivity/specificity of MR colonography versus colonoscopy []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Suspicion of colorectal polyps or cancer

• Referred for colonoscopy

Exclusion Criteria:

• Suspicion of IBD

• Pacemaker

• Metal in the body

• Claustrophobia

• Pregnancy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Radiology Copenhagen University Hospital Herlev	Herlev		Denmark	DK-2730

Sponsors and Collaborators

• Herlev Hospital
• University Hospital, Gentofte, Copenhagen

Investigators

• Principal Investigator: Michael P Achiam, M.D., Department of Radiology Copenhagen University Hospital Herlev

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00114842
• Other Study ID Numbers: KA05029-MA; KA05029
• First Posted: Jun 20, 2005
• Last Update Posted: Sep 20, 2007
• Last Verified: Sep 1, 2007

• Keywords provided by , ,: colorectal polyps; colorectal cancer; Virtual colonoscopy; Fecal tagging; MR colonography
• Additional relevant MeSH terms: Colorectal Neoplasms

Study Results

No Results Posted as of Sep 20, 2007