Total Preoperative MR Diagnostic Evaluation Versus Standard Diagnostic Evaluation in Patients With Rectal Cancer

NCT01544452 | Terminated

• 1 other identifier: H-1-2009-094
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

Patients with rectal cancer undergo MRI of the rectum, CT of the thorax and abdomen (or thorax x-ray and ultrasonic liver evaluation) and colonoscopy as a total diagnostic evaluation before surgery. MR colonography have been shown to have high sensitivity and specificity for larger polyps and cancer and MRI of the liver have been shown to have similar or higher sensitivity than CT of the liver for metastasis. Since patients already undergo MR of the rectum, the investigators have proposed a total diagnostic evaluation with MRI of the liver, abdomen, colonography and rectum in one session (minus thorax evaluation) instead of two or three different methods of evaluation. The investigators hypothesis is that the total MR evaluation is equal or superior to the existing preoperative evaluation regarding the diagnosis of synchronous cancers and liver metastasis and regarding cost-benefit for the total diagnostic evaluation.

Conditions

Rectal Cancer; Liver Metastasis

Keywords

MR; CT; ultrasonography; MR colonography; MR rectum; MR liver

Outcome Measures

Primary Outcomes (1)

• Synchronous colon cancers and liver metastasis

  2013 (up to 4 years)

Secondary Outcomes (1)

• sensitivity/specificity of CT versus MR versus Peroperative ultrasonography of the liver

  2013 (up to 4 years)

Study Arms (2)

Total preoperative MR evaluation

OTHER

Total diagnostic evaluation with MRI of the liver, abdomen, colonography and rectum in one session combined with CT thorax

Procedure: MR colonography and MR of the liver

Standard diagnostic evaluation

OTHER

Standard preoperative diagnostic evaluation for patients with rectal cancer, incl. CT thorax, abdomen and MRI of the rectum and colonoscopy

Procedure: Standard diagnostic evaluation

Interventions

MR colonography and MR of the liver PROCEDURE

Altered planned surgical procedure if MR colonoscopy reveals synchronous cancer or larger polyps

Also known as: Total preoperative MR evaluation

Total preoperative MR evaluation

Standard diagnostic evaluation PROCEDURE

Altered planned surgical procedure if MR colonoscopy reveals synchronous cancer or larger polyps

Standard diagnostic evaluation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients scheduled for operation for rectal cancer

You may not qualify if:

• Inflammatory bowel disease (IBD)
• Pacemaker
• Metal in the investigated areas
• Claustrophobia
• Age \< 18 years
• Pregnancy
• Kidney disease
• Arrhythmia

Sponsors & Collaborators

• Herlev Hospital: lead

Study Sites (1)

Department of surgical gastroenterology, Copenhagen University Hospital at Herlev

Copenhagen, 2730, Denmark

Location

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Michael P Achiam, MD, Ph.D.

  Herlev Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Resident, M.D., ph.d.

Study Record Dates

• First Submitted: November 7, 2011
• First Posted: March 6, 2012
• Study Start: August 1, 2010
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: December 2, 2014

Record last verified: 2014-11

Locations

DK (1)