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

This study has been completed.
Sponsor:
Collaborator:
University Hospital, Gentofte, Copenhagen
Information provided by:
Herlev Hospital
ClinicalTrials.gov Identifier:
NCT00300547
First received: March 8, 2006
Last updated: August 17, 2010
Last verified: March 2006

March 8, 2006
August 17, 2010
March 2007
April 2008   (final data collection date for primary outcome measure)
Feasibility of MR colonography to diagnose possible synchronous carcinomas and polyps [ Time Frame: 3 ] [ Designated as safety issue: No ]
Feasibility of MR colonography to diagnose possible synchronous carcinomas and polyps
Complete list of historical versions of study NCT00300547 on ClinicalTrials.gov Archive Site
Altered operative strategy due to findings on MR colonography [ Time Frame: 3 ] [ Designated as safety issue: No ]
Altered operative strategy due to findings on MR colonography
Not Provided
Not Provided
 
Preoperative Assessment for Synchronous Carcinoma or Polyps With Magnetic Resonance (MR) Colonography
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.

Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Obstructing Colorectal Cancer
Procedure: MR colonography
Altered planned surgical procedure if MR colonoscopy reveals synchronous cancer or larger polyps
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
Not Provided
April 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Obstructing colorectal cancer

Exclusion Criteria:

  • Suspicion of IBD
  • Pacemaker
  • Metal in the body
  • Claustrophobia
  • Pregnancy
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT00300547
KA05030-MA, KA05030
Not Provided
Michael Achiam, MD, Herlev Hospital
Herlev Hospital
University Hospital, Gentofte, Copenhagen
Principal Investigator: Michael P Achiam, MD Department of Radiology Copenhagen University Hospital Herlev
Herlev Hospital
March 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP