MR Colonography With Fecal Tagging. Barium vs. BariumFerumoxsil

Colorectal Cancer Clinical Trial

Official title:

MR Colonography With Fecal Tagging. Barium vs. BariumFerumoxsil

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00332943
• Other study ID #: KA-20060039 MA
• Secondary ID: KA-20060039.
• Status: Completed
• Phase: Phase 4
• First received: June 1, 2006
• Last updated: September 19, 2007
• Start date: December 2005
• Est. completion date: May 2006

Study information

• Verified date: September 2007
• Source: Herlev Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: National Board of Health
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: May 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms
• Polyps

Intervention

Procedure:
• MR colonography with fecal tagging

Locations

Country	Name	City	State
Denmark	Department of Radiology Copenhagen University Hospital Herlev	Copenhagen

Sponsors (2)

Lead Sponsor	Collaborator
Herlev Hospital	University Hospital, Gentofte, Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of fecal tagging agent
Primary	Sensitivity of VAS score vs. ReCon score