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MR Colonography With Fecal Tagging. Barium vs. BariumFerumoxsil

This study has been completed.
Sponsor:
Collaborator:
University Hospital, Gentofte, Copenhagen
Information provided by:
Herlev Hospital
ClinicalTrials.gov Identifier:
NCT00332943
First received: June 1, 2006
Last updated: September 19, 2007
Last verified: September 2007
History of Changes
  Purpose

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 Intervention Phase
Colorectal Cancer
Polyps
 Procedure: MR colonography with fecal tagging
 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. Barium vs. BariumFerumoxsil

Resource links provided by NLM:

Drug Information available for: Barium
U.S. FDA Resources

Further study details as provided by Herlev Hospital:

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

Estimated Enrollment: 20
Study Start Date: December 2005
Study Completion Date: May 2006
  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: NCT00332943

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

No publications provided

ClinicalTrials.gov Identifier: NCT00332943     History of Changes
Other Study ID Numbers: KA-20060039 MA, KA-20060039.
Study First Received: June 1, 2006
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 21, 2013