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Preoperative Assessment of Colon Tumor

NCT ID: NCT00114829

Last Updated: 2006-03-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-07-31

Brief Summary

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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

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Conditions

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Colorectal Cancer Colorectal Tumor

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Interventions

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MR colonography with dynamic contrast uptake

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Colorectal cancer
* Colorectal tumor

Exclusion Criteria

* Active diverticulitis
* Pacemaker
* Metal in the body
* Claustrophobia
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Gentofte, Copenhagen

OTHER

Sponsor Role collaborator

Herlev Hospital

OTHER

Sponsor Role lead

Principal Investigators

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Michael P Achiam, M.D.

Role: PRINCIPAL_INVESTIGATOR

Department of Radiology Copenhagen University Hospital Herlev

Locations

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Department of Radiology Copenhagen University Hospital Herlev

Herlev, , Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Michael P Achiam, M.D

Role: CONTACT

[email protected]
+45 44884391

Facility Contacts

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Michael P Achiam, M.D

Role: primary

[email protected]
+45 44884391

References

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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.

Reference Type DERIVED
PMID: 19419830 (View on PubMed)

Other Identifiers

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KA05028

Identifier Type: -

Identifier Source: secondary_id

KA05028-MA

Identifier Type: -

Identifier Source: org_study_id