Preoperative Assessment for Synchronous Carcinoma or Polyps With Magnetic Resonance (MR) Colonography

NCT ID: NCT00300547

Last Updated: 2010-08-18

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

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Brief Summary

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The purpose of this study is to diagnose possible synchronous carcinomas and polyps with magnetic resonance (MR) colonography in patients booked for operation because of carcinoma in the descending or sigmoid colon, where a preoperative full colonoscopy is not possible. Two days before colonography, patients ingest a 200 ml Barium sulfate solution four times a day, which will render fecal masses "invisible" on the following MR colonography. The study is primarily a feasibility study with altered operative strategy as a secondary end-point. Gold standard is colonoscopy and operation.

Detailed Description

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Conditions

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Obstructing Colorectal Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Interventions

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MR colonography

Altered planned surgical procedure if MR colonoscopy reveals synchronous cancer or larger polyps

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Obstructing colorectal cancer

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

Responsible Party

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Herlev Hospital

Principal Investigators

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Michael P Achiam, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Radiology Copenhagen University Hospital Herlev

Locations

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Department of Radiology Copenhagen University Hospital Herlev

Copenhagen, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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KA05030

Identifier Type: -

Identifier Source: secondary_id

KA05030-MA

Identifier Type: -

Identifier Source: org_study_id

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