Back to resultsMR Colonography With Fecal Tagging. Barium vs. BariumFerumoxsil
Primary Purpose
Colorectal Cancer, Polyps
Status
Completed
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
MR colonography with fecal tagging
Sponsored by
About this trial
This is an interventional diagnostic trial for Colorectal Cancer focused on measuring colorectal polyps, colorectal cancer, Virtual colonoscopy, Fecal tagging, MR colonography
Eligibility Criteria
Inclusion Criteria: Suspicion of colorectal polyps or cancer Referred for colonoscopy Exclusion Criteria: Suspicion of IBD Pacemaker Metal in the body Claustrophobia Pregnancy
Sites / Locations
- Department of Radiology Copenhagen University Hospital Herlev
Outcomes
Primary Outcome Measures
Quality of fecal tagging agent
Sensitivity of VAS score vs. ReCon score
Secondary Outcome Measures
Full Information
NCT ID
NCT00332943
First Posted
June 1, 2006
Last Updated
September 19, 2007
Sponsor
Herlev Hospital
Collaborators
University Hospital, Gentofte, Copenhagen
1. Study Identification
Unique Protocol Identification Number
NCT00332943
Brief Title
MR Colonography With Fecal Tagging. Barium vs. BariumFerumoxsil
Official Title
MR Colonography With Fecal Tagging. Barium vs. BariumFerumoxsil
Study Type
Interventional
2. Study Status
Record Verification Date
September 2007
Overall Recruitment Status
Completed
Study Start Date
December 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Herlev Hospital
Collaborators
University Hospital, Gentofte, Copenhagen
4. Oversight
5. 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer, Polyps
Keywords
colorectal polyps, colorectal cancer, Virtual colonoscopy, Fecal tagging, MR colonography
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
MR colonography with fecal tagging
Primary Outcome Measure Information:
Title
Quality of fecal tagging agent
Title
Sensitivity of VAS score vs. ReCon score
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Suspicion of colorectal polyps or cancer
Referred for colonoscopy
Exclusion Criteria:
Suspicion of IBD
Pacemaker
Metal in the body
Claustrophobia
Pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael P Achiam, MD
Organizational Affiliation
Department of Radiology Copenhagen University Hospital Herlev
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Radiology Copenhagen University Hospital Herlev
City
Copenhagen
Country
Denmark
12. IPD Sharing Statement
Learn more about this trial
MR Colonography With Fecal Tagging. Barium vs. BariumFerumoxsil
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