NCT00114829

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for phase_4 colorectal-cancer

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 17, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 20, 2005

Completed
11 days until next milestone

Study Start

First participant enrolled

July 1, 2005

Completed
Last Updated

March 9, 2006

Status Verified

May 1, 2005

First QC Date

June 17, 2005

Last Update Submit

March 8, 2006

Conditions

Colorectal CancerColorectal Tumor

Keywords

Colorectal cancerColorectal tumorDynamic contrast uptakeMR colonography

Outcome Measures

Primary Outcomes (1)

  • Sensitivity in determining malignant or benign diagnose

Secondary Outcomes (1)

  • Sensitivity/specificity of MR colonography

Interventions

MR colonography with dynamic contrast uptakePROCEDURE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Colorectal cancer
  • Colorectal tumor

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Radiology Copenhagen University Hospital Herlev

Herlev, Dk-.2730, Denmark

RECRUITING

Related Publications (1)

  • 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.

    PMID: 19419830DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Michael P Achiam, M.D.

    Department of Radiology Copenhagen University Hospital Herlev

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael P Achiam, M.D

CONTACT

+45 44884391achiam1@dadlnet.dk

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
DOUBLE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 17, 2005

First Posted

June 20, 2005

Study Start

July 1, 2005

Last Updated

March 9, 2006

Record last verified: 2005-05

Locations

DK(1)