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
Sponsor:
Collaborator:
University Hospital, Gentofte, Copenhagen
Information provided by:
Herlev Hospital
ClinicalTrials.gov Identifier:
NCT00114829
First received: June 17, 2005
Last updated: March 8, 2006
Last verified: May 2005
  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
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
  Eligibility

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

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 ClinicalTrials.gov identifier: 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

No publications provided by Herlev Hospital

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

ClinicalTrials.gov processed this record on August 26, 2014