Back to resultsMagnetic Resonance (MR) Colonography With Fecal Tagging
Primary Purpose
Colorectal Cancer, Polyps
Status
Completed
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
MR colonography
Sponsored by
About this trial
This is an interventional diagnostic trial for Colorectal Cancer focused on measuring colorectal polyps, colorectal cancer, Virtual colonoscopy, Fecal tagging, MR colonography
Eligibility Criteria
Inclusion Criteria: Suspicion of colorectal polyps or cancer Referred for colonoscopy Exclusion Criteria: Suspicion of IBD Pacemaker Metal in the body Claustrophobia Pregnancy
Sites / Locations
- Department of Radiology Copenhagen University Hospital Herlev
Outcomes
Primary Outcome Measures
Sensitivity/specificity for water versus air for distension of colon in MR colonography
Secondary Outcome Measures
Feasibility of MR colonography with fecal tagging
Sensitivity/specificity of MR colonography versus colonoscopy
Full Information
NCT ID
NCT00114842
First Posted
June 17, 2005
Last Updated
September 19, 2007
Sponsor
Herlev Hospital
Collaborators
University Hospital, Gentofte, Copenhagen
1. Study Identification
Unique Protocol Identification Number
NCT00114842
Brief Title
Magnetic Resonance (MR) Colonography With Fecal Tagging
Official Title
MR Colonography With Fecal Tagging: A Prospective, Randomized Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2007
Overall Recruitment Status
Completed
Study Start Date
March 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Herlev Hospital
Collaborators
University Hospital, Gentofte, Copenhagen
4. Oversight
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer, Polyps
Keywords
colorectal polyps, colorectal cancer, Virtual colonoscopy, Fecal tagging, MR colonography
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
MR colonography
Primary Outcome Measure Information:
Title
Sensitivity/specificity for water versus air for distension of colon in MR colonography
Secondary Outcome Measure Information:
Title
Feasibility of MR colonography with fecal tagging
Title
Sensitivity/specificity of MR colonography versus colonoscopy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Suspicion of colorectal polyps or cancer
Referred for colonoscopy
Exclusion Criteria:
Suspicion of IBD
Pacemaker
Metal in the body
Claustrophobia
Pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael P Achiam, M.D.
Organizational Affiliation
Department of Radiology Copenhagen University Hospital Herlev
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Radiology Copenhagen University Hospital Herlev
City
Herlev
ZIP/Postal Code
DK-2730
Country
Denmark
12. IPD Sharing Statement
Learn more about this trial
Magnetic Resonance (MR) Colonography With Fecal Tagging
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