Preoperative Assessment of Colon Tumor

Phase 4

• Conditions: Colorectal Cancer; Colorectal Tumor

• Registration Number: NCT00114829
• Lead Sponsor: Herlev Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2005-05
• Study First Submitted: 2005-06-17
• Study First Submitted QC: 2005-06-17
• Study First Posted: 2005-06-20
• Study Start: 2005-07
• Last Update Submitted: 2006-03-08
• Last Update Posted: 2006-03-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Colorectal cancer
• Colorectal tumor

Exclusion Criteria

• Active diverticulitis
• Pacemaker
• Metal in the body
• Claustrophobia

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Sensitivity in determining malignant or benign diagnose

Secondary Outcome Measures

Name	Time	Method
Sensitivity/specificity of MR colonography

Trial Locations

Locations (1)

Department of Radiology Copenhagen University Hospital Herlev; 🇩🇰 Herlev, Denmark