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
  Purpose

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.


Condition Intervention Phase
Obstructing Colorectal Cancer
Procedure: MR colonography
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Preoperative Assessment for Synchronous Carcinoma or Polyps With MR Colonography in Patients With Obstructing Cancer. A Prospective Study.

Resource links provided by NLM:


Further study details as provided by Herlev Hospital:

Primary Outcome Measures:
  • Feasibility of MR colonography to diagnose possible synchronous carcinomas and polyps [ Time Frame: 3 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Altered operative strategy due to findings on MR colonography [ Time Frame: 3 ] [ Designated as safety issue: No ]

Enrollment: 50
Study Start Date: March 2007
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: MR colonography
    Altered planned surgical procedure if MR colonoscopy reveals synchronous cancer or larger polyps
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Obstructing colorectal cancer

Exclusion Criteria:

  • Suspicion of IBD
  • Pacemaker
  • Metal in the body
  • Claustrophobia
  • Pregnancy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00300547

Locations
Denmark
Department of Radiology Copenhagen University Hospital Herlev
Copenhagen, Denmark, DK-2730
Sponsors and Collaborators
Herlev Hospital
University Hospital, Gentofte, Copenhagen
Investigators
Principal Investigator: Michael P Achiam, MD Department of Radiology Copenhagen University Hospital Herlev
  More Information

No publications provided

Responsible Party: Michael Achiam, MD, Herlev Hospital
ClinicalTrials.gov Identifier: NCT00300547     History of Changes
Other Study ID Numbers: KA05030-MA, KA05030
Study First Received: March 8, 2006
Last Updated: August 17, 2010
Health Authority: Denmark: National Board of Health

Keywords provided by Herlev Hospital:
colorectal cancer
polyps
Virtual colonoscopy
synchronous carcinoma
MR colonography

Additional relevant MeSH terms:
Carcinoma
Colorectal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on August 28, 2014