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MR Colonography With Fecal Tagging. Barium vs. BariumFerumoxsil

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00332943
Recruitment Status : Completed
First Posted : June 2, 2006
Last Update Posted : September 20, 2007
University Hospital, Gentofte, Copenhagen
Information provided by:
Herlev Hospital

Brief Summary:
The purpose of this study is to determine whether Barium or BariumFerumoxsil is better for fecal tagging in MR colonography. Patients referred to colonoscopy are offered MR colonography before colonoscopy. Two days before colonography, patients ingest either a contrast agent A (200 ml Barium sulphate solution 1g/ml)) four times a day or a 200 ml contrast agent B (Barium sulfate(25%) and Ferumoxil(75%)) four times a day, which will render fecal masses "invisible" on the following MR colonography. The patients are randomised to either contrast agent A or B. The examinations are evaluated by two independent blinded readers, who will rate the tagging quality of the contrast agents. The quality of tagging will be rated by a Visual Analog Scale (VAS) and Relative contrast (ReCon = Iwall - Ilumen/ Iwall + Ilumen).

Condition or disease Intervention/treatment Phase
Colorectal Cancer Polyps Procedure: MR colonography with fecal tagging Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Diagnostic
Official Title: MR Colonography With Fecal Tagging. Barium vs. BariumFerumoxsil
Study Start Date : December 2005
Actual Study Completion Date : May 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bowel Movement
Drug Information available for: Barium

Primary Outcome Measures :
  1. Quality of fecal tagging agent
  2. Sensitivity of VAS score vs. ReCon score

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00332943

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Department of Radiology Copenhagen University Hospital Herlev
Copenhagen, Denmark
Sponsors and Collaborators
Herlev Hospital
University Hospital, Gentofte, Copenhagen
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Principal Investigator: Michael P Achiam, MD Department of Radiology Copenhagen University Hospital Herlev

Layout table for additonal information Identifier: NCT00332943    
Other Study ID Numbers: KA-20060039 MA
First Posted: June 2, 2006    Key Record Dates
Last Update Posted: September 20, 2007
Last Verified: September 2007
Keywords provided by Herlev Hospital:
colorectal polyps
colorectal cancer
Virtual colonoscopy
Fecal tagging
MR colonography
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases