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Preoperative Assessment of Colon Tumor

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2005 by Herlev Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00114829
First Posted: June 20, 2005
Last Update Posted: March 9, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
University Hospital, Gentofte, Copenhagen
Information provided by:
Herlev Hospital
  Purpose
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
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Diagnostic
Official Title: Preoperative Assessment of Colon Tumor: A Prospective, Blinded Study.

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
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Colorectal cancer
  • Colorectal tumor

Exclusion Criteria:

  • Active diverticulitis
  • Pacemaker
  • Metal in the body
  • Claustrophobia
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00114829


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

Locations
Denmark
Department of Radiology Copenhagen University Hospital Herlev Recruiting
Herlev, Denmark, Dk-.2730
Contact: Michael P Achiam, M.D    +45 44884391    achiam1@dadlnet.dk   
Principal Investigator: Michael P Achiam, M.D.         
Sponsors and Collaborators
Herlev Hospital
University Hospital, Gentofte, Copenhagen
Investigators
Principal Investigator: Michael P Achiam, M.D. Department of Radiology Copenhagen University Hospital Herlev
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00114829     History of Changes
Other Study ID Numbers: KA05028-MA
KA05028
First Submitted: June 17, 2005
First Posted: June 20, 2005
Last Update Posted: March 9, 2006
Last Verified: May 2005

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

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases