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Magnetic Resonance (MR) Colonography With Fecal Tagging

NCT ID: NCT00114842

Last Updated: 2007-09-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-03-31

Study Completion Date

2007-03-31

Brief Summary

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The purpose of this study is to determine if MR colonography with fecal tagging is better using air or water for distension of the colon. Patients referred to colonoscopy are offered MR colonography before colonoscopy. Two days before colonography, patients ingest a 200 ml Barium sulfate solution 2% four times a day, which will render fecal masses "invisible" on the following MR colonography. Air or water (randomised trial) is used for distension of the colon. The examinations are evaluated by two independent blinded readers.

Detailed Description

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Conditions

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Colorectal Cancer Polyps

Keywords

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colorectal polyps colorectal cancer Virtual colonoscopy Fecal tagging MR colonography

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Interventions

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MR colonography

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Suspicion of colorectal polyps or cancer
* Referred for colonoscopy

Exclusion Criteria

* Suspicion of IBD
* Pacemaker
* Metal in the body
* Claustrophobia
* Pregnancy
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Gentofte, Copenhagen

OTHER

Sponsor Role collaborator

Herlev Hospital

OTHER

Sponsor Role lead

Principal Investigators

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Michael P Achiam, M.D.

Role: PRINCIPAL_INVESTIGATOR

Department of Radiology Copenhagen University Hospital Herlev

Locations

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Department of Radiology Copenhagen University Hospital Herlev

Herlev, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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KA05029

Identifier Type: -

Identifier Source: secondary_id

KA05029-MA

Identifier Type: -

Identifier Source: org_study_id