MR Colonography With Fecal Tagging. Barium vs. BariumFerumoxsil

• Sponsor: Herlev Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT00332943
• Collaborator: University Hospital, Gentofte, Copenhagen (Other)
• Enrollment: 20
• Location: 1
• Duration (Months): 5
• Patients Per Site Per Month: 4

Study Details

Study Description

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

Study Design

• Study Type: Interventional
• Anticipated 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: Dec 1, 2005
• Actual Study Completion Date: May 1, 2006

Outcome Measures

Primary Outcome Measures

1. Quality of fecal tagging agent []

2. Sensitivity of VAS score vs. ReCon score []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00332943
• Other Study ID Numbers: KA-20060039 MA; KA-20060039.
• First Posted: Jun 2, 2006
• Last Update Posted: Sep 20, 2007
• Last Verified: Sep 1, 2007

• Keywords provided by , ,: colorectal polyps; colorectal cancer; Virtual colonoscopy; Fecal tagging; MR colonography
• Additional relevant MeSH terms: Colorectal Neoplasms

Study Results

No Results Posted as of Sep 20, 2007