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Preoperative Assessment for Synchronous Carcinoma or Polyps With MR Colonography
This study is not yet open for participant recruitment.
Verified by Herlev Hospital, March 2006
Sponsors and Collaborators: Herlev Hospital
University Hospital, Gentofte, Copenhagen
Information provided by: Herlev Hospital
ClinicalTrials.gov Identifier: NCT00300547
  Purpose

The purpose of this study is to diagnose possible synchronous carcinomas and polyps with 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 IV

MedlinePlus related topics: Cancer Colorectal Cancer
U.S. FDA Resources
Study Type: Interventional
Study Design: Diagnostic, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title: Preoperative Assessment for Synchronous Carcinoma or Polyps With MR Colonography in Patients With Obstructing Cancer. A Prospective Study.

Further study details as provided by Herlev Hospital:

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

Estimated Enrollment: 50
Study Start Date: March 2007
  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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00300547

Contacts
Contact: Michael P Achiam, M.D. +45 44884391 achiam1@dadlnet.dk

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

Study ID Numbers: KA05030-MA, KA05030
Study First Received: March 8, 2006
Last Updated: March 8, 2006
ClinicalTrials.gov Identifier: NCT00300547  
Health Authority: Denmark: National Board of Health

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

Study placed in the following topic categories:
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Colonic Diseases
Gastrointestinal Neoplasms
Polyps
Intestinal Diseases
Rectal Diseases
Intestinal Neoplasms
Colorectal Neoplasms
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on January 15, 2009