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

Primary Purpose

Obstructing Colorectal Cancer

Status

Completed

Phase

Phase 4

Locations

Denmark

Study Type

Interventional

Intervention

MR colonography

About this trial

This is an interventional diagnostic trial for Obstructing Colorectal Cancer focused on measuring colorectal cancer, polyps, Virtual colonoscopy, synchronous carcinoma, MR colonography

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Obstructing colorectal cancer 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

Feasibility of MR colonography to diagnose possible synchronous carcinomas and polyps

Secondary Outcome Measures

Altered operative strategy due to findings on MR colonography

Full Information

NCT ID

NCT00300547

First Posted

March 8, 2006

Last Updated

August 17, 2010

Sponsor

Herlev Hospital

Collaborators

University Hospital, Gentofte, Copenhagen

1. Study Identification

Unique Protocol Identification Number

NCT00300547

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2006

Overall Recruitment Status

Completed

Study Start Date

March 2007 (undefined)

Primary Completion Date

April 2008 (Actual)

Study Completion Date

undefined (undefined)

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obstructing Colorectal Cancer

Keywords

colorectal cancer, polyps, Virtual colonoscopy, synchronous carcinoma, MR colonography

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

50 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Procedure

Intervention Name(s)

MR colonography

Intervention Description

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

Primary Outcome Measure Information:

Title

Feasibility of MR colonography to diagnose possible synchronous carcinomas and polyps

Time Frame

Secondary Outcome Measure Information:

Title

Altered operative strategy due to findings on MR colonography

Time Frame

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Obstructing colorectal cancer 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

ZIP/Postal Code

DK-2730

Country

Denmark

12. IPD Sharing Statement

Learn more about this trial

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

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