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Clinical Trials/NCT00114829
NCT00114829UnknownPhase 4

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

Herlev Hospital2 sites in 1 country60 target enrollmentStarted: July 2005Last updated:
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Conditions

Trial Snapshot

Phase
Phase 4
Enrollment
60
Locations
2
Primary Endpoint
Sensitivity in determining malignant or benign diagnose
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Single Group
Primary Purpose
Diagnostic
Masking
Double

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Colorectal cancer
  • •Colorectal tumor

Exclusion Criteria

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

Outcomes

Primary Outcomes

Sensitivity in determining malignant or benign diagnose

Secondary Outcomes

  • Sensitivity/specificity of MR colonography

Investigators

Sponsor Class
Other

Study Sites (2)

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