Preoperative Assessment of Colon Tumor

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2005 by Herlev Hospital.
Recruitment status was  Recruiting
University Hospital, Gentofte, Copenhagen
Information provided by:
Herlev Hospital Identifier:
First received: June 17, 2005
Last updated: March 8, 2006
Last verified: May 2005
The purpose of this study is to determine whether a colonic tumor can be classified as malignant or benign with magnetic resonance (MR) colonography. Patients with a verified colon carcinoma or benign tumor based on diverticulitis are offered a MR colonography with intravenous (I.V.) contrast. The tumor is classified as malignant or benign by assessing the dynamic contrast uptake and morphology. The Investigator is blinded from the verified diagnosis and the MR classification is compared to the histological diagnosis.

Condition Intervention Phase
Colorectal Cancer
Colorectal Tumor
Procedure: MR colonography with dynamic contrast uptake
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Diagnostic
Official Title: Preoperative Assessment of Colon Tumor: A Prospective, Blinded Study.

Resource links provided by NLM:

Further study details as provided by Herlev Hospital:

Primary Outcome Measures:
  • Sensitivity in determining malignant or benign diagnose

Secondary Outcome Measures:
  • Sensitivity/specificity of MR colonography

Estimated Enrollment: 60
Study Start Date: July 2005

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

Inclusion Criteria:

  • Colorectal cancer
  • Colorectal tumor

Exclusion Criteria:

  • Active diverticulitis
  • Pacemaker
  • Metal in the body
  • Claustrophobia
  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 identifier: NCT00114829

Contact: Michael P Achiam, M.D +45 44884391

Department of Radiology Copenhagen University Hospital Herlev Recruiting
Herlev, Denmark, Dk-.2730
Contact: Michael P Achiam, M.D    +45 44884391   
Principal Investigator: Michael P Achiam, M.D.         
Sponsors and Collaborators
Herlev Hospital
University Hospital, Gentofte, Copenhagen
Principal Investigator: Michael P Achiam, M.D. Department of Radiology Copenhagen University Hospital Herlev
  More Information

No publications provided by Herlev Hospital

Additional publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00114829     History of Changes
Other Study ID Numbers: KA05028-MA, KA05028
Study First Received: June 17, 2005
Last Updated: March 8, 2006
Health Authority: Denmark: National Board of Health

Keywords provided by Herlev Hospital:
Colorectal cancer
Colorectal tumor
Dynamic contrast uptake
MR colonography

Additional relevant MeSH terms:
Colorectal Neoplasms
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms by Site
Rectal Diseases processed this record on November 27, 2015