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Magnetic Resonance (MR) Colonography With Fecal Tagging

This study has been completed.
Sponsor:
Collaborator:
University Hospital, Gentofte, Copenhagen
Information provided by:
Herlev Hospital
ClinicalTrials.gov Identifier:
NCT00114842
First received: June 17, 2005
Last updated: September 19, 2007
Last verified: September 2007
History of Changes
  Purpose

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 Intervention Phase
Colorectal Cancer
Polyps
 Procedure: MR colonography
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Diagnostic
Official Title: MR Colonography With Fecal Tagging: A Prospective, Randomized Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Herlev Hospital:

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

Estimated Enrollment: 60
Study Start Date: March 2006
Study Completion Date: March 2007
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00114842

Locations
Denmark
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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00114842     History of Changes
Other Study ID Numbers: KA05029-MA, KA05029
Study First Received: June 17, 2005
Last Updated: September 19, 2007
Health Authority: Denmark: National Board of Health

Keywords provided by Herlev Hospital:
colorectal polyps
colorectal cancer
Virtual colonoscopy
Fecal tagging
MR colonography

Additional relevant MeSH terms:
Colorectal Neoplasms
Polyps
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
 Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on May 23, 2013