Preoperative Assessment of Colon Tumor

• Sponsor: Herlev Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT00114829
• Collaborator: University Hospital, Gentofte, Copenhagen (Other)
• Enrollment: 60
• Location: 1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Colorectal Cancer; Colorectal Tumor	Procedure: MR colonography with dynamic contrast uptake	Phase 4

Study Design

• Study Type: Interventional
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: Double
• Primary Purpose: Diagnostic
• Official Title: Preoperative Assessment of Colon Tumor: A Prospective, Blinded Study.
• Study Start Date: Jul 1, 2005

Outcome Measures

Primary Outcome Measures

1. Sensitivity in determining malignant or benign diagnose []

Secondary Outcome Measures

1. Sensitivity/specificity of MR colonography []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Colorectal cancer

• Colorectal tumor

Exclusion Criteria:

• Active diverticulitis

• Pacemaker

• Metal in the body

• Claustrophobia

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Radiology Copenhagen University Hospital Herlev	Herlev		Denmark	Dk-.2730

Sponsors and Collaborators

• Herlev Hospital
• University Hospital, Gentofte, Copenhagen

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00114829
• Other Study ID Numbers: KA05028-MA; KA05028
• First Posted: Jun 20, 2005
• Last Update Posted: Mar 9, 2006
• Last Verified: May 1, 2005

• Keywords provided by , ,: Colorectal cancer; Colorectal tumor; Dynamic contrast uptake; MR colonography
• Additional relevant MeSH terms: Colorectal Neoplasms

Study Results

No Results Posted as of Mar 9, 2006