MR Colonography With Fecal Tagging. Barium vs. BariumFerumoxsil

Phase 4

Completed

• Conditions: Colorectal Cancer; Polyps

• Registration Number: NCT00332943
• Lead Sponsor: 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2005-12
• Study Completion: 2006-05
• Study First Submitted: 2006-06-01
• Study First Submitted QC: 2006-06-01
• Study First Posted: 2006-06-02
• Status Verified: 2007-09
• Last Update Submitted: 2007-09-19
• Last Update Posted: 2007-09-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Suspicion of colorectal polyps or cancer
• Referred for colonoscopy

Exclusion Criteria

• Suspicion of IBD
• Pacemaker
• Metal in the body
• Claustrophobia
• Pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Sensitivity of VAS score vs. ReCon score
Quality of fecal tagging agent

Trial Locations

Locations (1)

Department of Radiology Copenhagen University Hospital Herlev; 🇩🇰 Copenhagen, Denmark