Preoperative Assessment of Colon Tumor

March 8, 2006 updated by: Herlev Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Herlev, Denmark, Dk-.2730
        • Recruiting
        • Department of Radiology Copenhagen University Hospital Herlev
        • Contact:
        • Principal Investigator:
          • Michael P Achiam, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Colorectal cancer
  • Colorectal tumor

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Sensitivity in determining malignant or benign diagnose

Secondary Outcome Measures

Outcome Measure
Sensitivity/specificity of MR colonography

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Herlev Hospital

Collaborators

University Hospital, Gentofte, Copenhagen

Investigators

  • Principal Investigator: Michael P Achiam, M.D., Department of Radiology Copenhagen University Hospital Herlev

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2005

Study Registration Dates

First Submitted

June 17, 2005

First Submitted That Met QC Criteria

June 17, 2005

First Posted (Estimate)

June 20, 2005

Study Record Updates

Last Update Posted (Estimate)

March 9, 2006

Last Update Submitted That Met QC Criteria

March 8, 2006

Last Verified

May 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KA05028-MA
  • KA05028

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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