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

Primary Purpose

Rectal Cancer, Liver Metastasis

Status
Terminated
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
MR colonography and MR of the liver
Standard diagnostic evaluation
Sponsored by
Herlev Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Rectal Cancer focused on measuring MR, CT, ultrasonography, MR colonography, MR rectum, MR liver

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients scheduled for operation for rectal cancer

Exclusion Criteria:

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

Sites / Locations

  • Department of surgical gastroenterology, Copenhagen University Hospital at Herlev

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Total preoperative MR evaluation

Standard diagnostic evaluation

Arm Description

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

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

Outcomes

Primary Outcome Measures

Synchronous colon cancers and liver metastasis

Secondary Outcome Measures

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

Full Information

First Posted
November 7, 2011
Last Updated
November 26, 2014
Sponsor
Herlev Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01544452
Brief Title
Total Preoperative MR Diagnostic Evaluation Versus Standard Diagnostic Evaluation in Patients With Rectal Cancer
Official Title
Prospective Randomized Study of Total Preoperative MR Diagnostic Evaluation Versus Standard Diagnostic Evaluation in Patients With Rectal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
November 2014
Overall Recruitment Status
Terminated
Why Stopped
Lack of MR scanning capacity
Study Start Date
August 2010 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
February 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Herlev Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Colorectal cancer (CRC) is among the most common cancer forms in Denmark with an approximate of 4300 new cases in Denmark annually, of which rectal cancer represents approximately 1400 new cases each year. It is also well known that synchronous cancer and polyps are present in up to 11% and 58% respectively in patients with CRC. It is assumed that adenomas constitute a precursor for cancer and it is thus speculated that the detection and removal of the adenoma could reduce the incidence and mortality of colorectal cancer. Danish Colorectal Cancer Group (DCCG) and the Danish Surgical Society (DKS) currently recommend full colonic investigation as part of the preoperative assessment, which also includes MRI of the rectum, ultrasound of the liver and chest X-ray (or abdominal /chest CT) to locate possible metastasis or synchronous tumors. However, it is often difficult to implement the preoperative colonic investigation due to lack of capacity or tumor stenosis. A recent Danish study showed that up to 78% of all patients with colorectal cancer had not received the full colonic investigation preoperatively. In this instance the recommendation from DCCG & DKS is that patients in the absence of complete colonic investigation preoperatively, should undergo colonoscopy within 3 months postoperatively. Within the last 15 years new non-invasive imaging techniques have been developed, this includes MR colonography (MRC). Like conventional colonoscopy, MRC requires bowel cleansing, since feces can create artifacts that can hide or mimic polyps and abnormalities. After cleansing the colon is distended by water using a rectal catheter. Since it is only water that needs to pass through a possibly stenotic colon segment, there is a better chance to successfully examine the entire colon compared to a colonoscopy. A recent study showed a 98% success rate using MRC to examine the entire colon in patients with CRC having colon stenosis. The MRC is preformed after the colon is fully distended with water and depending on the resolution needed the scan times are between 10 and 15 minutes. Data processing, reconstruction and analysis are made at an independent workstation. The advantages of MRC are its non-invasive nature, short examination time, and the fact that sedation is unnecessary. This makes it possible for patients to be discharged directly after the imaging procedure as opposed to the necessity for admission after a colonoscopy until the effects of the sedative drugs have worn off. Furthermore, it is assumed that patient compliance is much higher in MRC, since almost every patient finds it less unpleasant than colonoscopy. MRI of the liver is a well-known procedure that has shown good results in the diagnosis of hepatic metastases and primary cancers. Several studies have shown that it is equal or better than CT and ultrasound of the liver. Currently there are no studies, which make the overall preoperative assessment by means of one investigating technique, namely MRI. The investigators have previously studied the sensitivity/specificity and patient satisfaction by MRI colonography with fecal tagging. In this study the investigators want to investigate the quality of MR-colonography with bowel cleansing, also assessing the economical aspects of an overall examination of the rectum, colon and liver in patients with rectal cancer.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Cancer, Liver Metastasis
Keywords
MR, CT, ultrasonography, MR colonography, MR rectum, MR liver

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
75 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Total preoperative MR evaluation
Arm Type
Other
Arm Description
Total diagnostic evaluation with MRI of the liver, abdomen, colonography and rectum in one session combined with CT thorax
Arm Title
Standard diagnostic evaluation
Arm Type
Other
Arm Description
Standard preoperative diagnostic evaluation for patients with rectal cancer, incl. CT thorax, abdomen and MRI of the rectum and colonoscopy
Intervention Type
Procedure
Intervention Name(s)
MR colonography and MR of the liver
Other Intervention Name(s)
Total preoperative MR evaluation
Intervention Description
Altered planned surgical procedure if MR colonoscopy reveals synchronous cancer or larger polyps
Intervention Type
Procedure
Intervention Name(s)
Standard diagnostic evaluation
Intervention Description
Altered planned surgical procedure if MR colonoscopy reveals synchronous cancer or larger polyps
Primary Outcome Measure Information:
Title
Synchronous colon cancers and liver metastasis
Time Frame
2013 (up to 4 years)
Secondary Outcome Measure Information:
Title
sensitivity/specificity of CT versus MR versus Peroperative ultrasonography of the liver
Time Frame
2013 (up to 4 years)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients scheduled for operation for rectal cancer Exclusion Criteria: Inflammatory bowel disease (IBD) Pacemaker Metal in the investigated areas Claustrophobia Age < 18 years Pregnancy Kidney disease Arrhythmia
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael P Achiam, MD, Ph.D.
Organizational Affiliation
Herlev Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of surgical gastroenterology, Copenhagen University Hospital at Herlev
City
Copenhagen
ZIP/Postal Code
2730
Country
Denmark

12. IPD Sharing Statement

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

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