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NCT00114829 Clinical Trial

Preoperative Assessment of Colon Tumor

Colorectal Cancer Clinical Trial

Official title:
Preoperative Assessment of Colon Tumor: A Prospective, Blinded Study.

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00114829
Other study ID # KA05028-MA
Secondary ID KA05028
Status Recruiting
Phase Phase 4
First received June 17, 2005
Last updated March 8, 2006
Start date July 2005

Study information
Verified date May 2005
Source Herlev Hospital
Contact Michael P Achiam, M.D
Phone +45 44884391
Email achiam1@dadlnet.dk
Is FDA regulated No
Health authority Denmark: National Board of Health
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 60
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Colorectal cancer

- Colorectal tumor

Exclusion Criteria:

- Active diverticulitis

- Pacemaker

- Metal in the body

- Claustrophobia

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

Intervention

Procedure:
• MR colonography with dynamic contrast uptake

Locations
Country Name City State
Denmark Department of Radiology Copenhagen University Hospital Herlev Herlev

Sponsors (2)
Lead Sponsor Collaborator
Herlev Hospital University Hospital, Gentofte, Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary Sensitivity in determining malignant or benign diagnose
Secondary Sensitivity/specificity of MR colonography
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