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Preoperative Assessment of Colon Tumor

Primary Purpose

Colorectal Cancer, Colorectal Tumor

Status

Unknown status

Phase

Phase 4

Locations

Denmark

Study Type

Interventional

Intervention

MR colonography with dynamic contrast uptake

About this trial

This is an interventional diagnostic trial for Colorectal Cancer focused on measuring Colorectal cancer, Colorectal tumor, Dynamic contrast uptake, MR colonography

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Colorectal cancer Colorectal tumor Exclusion Criteria: Active diverticulitis Pacemaker Metal in the body Claustrophobia

Sites / Locations

Department of Radiology Copenhagen University Hospital HerlevRecruiting

Outcomes

Primary Outcome Measures

Sensitivity in determining malignant or benign diagnose

Secondary Outcome Measures

Sensitivity/specificity of MR colonography

Full Information

NCT ID

NCT00114829

First Posted

June 17, 2005

Last Updated

March 8, 2006

Sponsor

Herlev Hospital

Collaborators

University Hospital, Gentofte, Copenhagen

1. Study Identification

Unique Protocol Identification Number

NCT00114829

Brief Title

Preoperative Assessment of Colon Tumor

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2005

Overall Recruitment Status

Unknown status

Study Start Date

July 2005 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Herlev Hospital

Collaborators

University Hospital, Gentofte, Copenhagen

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Colorectal Cancer, Colorectal Tumor

Keywords

Colorectal cancer, Colorectal tumor, Dynamic contrast uptake, MR colonography

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

Double

Allocation

Non-Randomized

Enrollment

60 (false)

8. Arms, Groups, and Interventions

Intervention Type

Procedure

Intervention Name(s)

MR colonography with dynamic contrast uptake

Primary Outcome Measure Information:

Title

Sensitivity in determining malignant or benign diagnose

Secondary Outcome Measure Information:

Title

Sensitivity/specificity of MR colonography

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Colorectal cancer Colorectal tumor Exclusion Criteria: Active diverticulitis Pacemaker Metal in the body Claustrophobia

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Michael P Achiam, M.D

Phone

+45 44884391

achiam1@dadlnet.dk

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Michael P Achiam, M.D.

Organizational Affiliation

Department of Radiology Copenhagen University Hospital Herlev

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of Radiology Copenhagen University Hospital Herlev

City

Herlev

ZIP/Postal Code

Dk-.2730

Country

Denmark

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Michael P Achiam, M.D

Phone

+45 44884391

achiam1@dadlnet.dk

First Name & Middle Initial & Last Name & Degree

Michael P Achiam, M.D.

12. IPD Sharing Statement

Citations:

PubMed Identifier

19419830

Citation

Achiam MP, Andersen LP, Klein M, Logager V, Chabanova E, Thomsen HS, Rosenberg J. Differentiation between benign and malignant colon tumors using fast dynamic gadolinium-enhanced MR colonography; a feasibility study. Eur J Radiol. 2010 Jun;74(3):e45-50. doi: 10.1016/j.ejrad.2009.03.033. Epub 2009 May 5.

Results Reference

derived

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Preoperative Assessment of Colon Tumor

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