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

August 17, 2010 updated by: Herlev Hospital

Preoperative Assessment for Synchronous Carcinoma or Polyps With MR Colonography in Patients With Obstructing Cancer. A Prospective Study.

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.

Study Overview

Status

Completed

Conditions

Obstructing Colorectal Cancer

Intervention / Treatment

Procedure: MR colonography

Study Type

Interventional

Enrollment (Actual)

Phase

Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Denmark
- - Copenhagen, Denmark, DK-2730
    - Department of Radiology Copenhagen University Hospital Herlev

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

Inclusion Criteria:

Obstructing colorectal cancer

Exclusion Criteria:

Suspicion of IBD
Pacemaker
Metal in the body
Claustrophobia
Pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: DIAGNOSTIC
Allocation: NON_RANDOMIZED
Interventional Model: SINGLE_GROUP
Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Feasibility of MR colonography to diagnose possible synchronous carcinomas and polyps Time Frame: 3	3

Secondary Outcome Measures

Outcome Measure	Time Frame
Altered operative strategy due to findings on MR colonography Time Frame: 3	3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Herlev Hospital

Collaborators

University Hospital, Gentofte, Copenhagen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2007

Primary Completion (ACTUAL)

April 1, 2008

Study Registration Dates

First Submitted

March 8, 2006

First Submitted That Met QC Criteria