Preoperative Assessment for Synchronous Carcinoma or Polyps With Magnetic Resonance (MR) Colonography

Obstructing Colorectal Cancer Clinical Trial

Official title:

Preoperative Assessment for Synchronous Carcinoma or Polyps With MR Colonography in Patients With Obstructing Cancer. A Prospective Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00300547
• Other study ID #: KA05030-MA
• Secondary ID: KA05030
• Status: Completed
• Phase: Phase 4
• First received: March 8, 2006
• Last updated: August 17, 2010
• Start date: March 2007

Study information

• Verified date: March 2006
• Source: Herlev Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: National Board of Health
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to diagnose possible synchronous carcinomas and polyps with magnetic resonance (MR) colonography in patients booked for operation because of carcinoma in the descending or sigmoid colon, where a preoperative full colonoscopy is not possible. Two days before colonography, patients ingest a 200 ml Barium sulfate solution four times a day, which will render fecal masses "invisible" on the following MR colonography. The study is primarily a feasibility study with altered operative strategy as a secondary end-point. Gold standard is colonoscopy and operation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Obstructing colorectal cancer

Exclusion Criteria:

• Suspicion of IBD

• Pacemaker

• Metal in the body

• Claustrophobia

• Pregnancy

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Obstructing Colorectal Cancer

Intervention

Procedure:
• MR colonography
Altered planned surgical procedure if MR colonoscopy reveals synchronous cancer or larger polyps

Locations

Country	Name	City	State
Denmark	Department of Radiology Copenhagen University Hospital Herlev	Copenhagen

Sponsors (2)

Lead Sponsor	Collaborator
Herlev Hospital	University Hospital, Gentofte, Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of MR colonography to diagnose possible synchronous carcinomas and polyps		3	No
Secondary	Altered operative strategy due to findings on MR colonography		3	No