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A Feasibility Study to Compare the Benefits of Endoscopic Tumor Clip Placement and 3T-MRI Simulation for Accurate Target Volume Definition for Rectal Cancer Patients Undergoing Pre-operative Chemoradiation

This study is currently recruiting participants.
Verified December 2012 by Alberta Health Services
Sponsor:
Collaborator:
IGAR Image guided adaptive radiotherapy
Information provided by (Responsible Party):
Alberta Health Services
ClinicalTrials.gov Identifier:
NCT01133340
First received: May 27, 2010
Last updated: December 10, 2012
Last verified: December 2012
History of Changes
  Purpose

This study is looking for a better way to define rectal tumors undergoing pre-operative radiation. MRI scanning generally results in more clear definition of the tumor that CT scanning. Insertion of radio opaque clips in the tumor site could also help to visualize the tumor better for radiotherapy treatment planning. The investigators believe both techniques would help the physician to define to cancer better than using CT scan alone. The investigators also will compare both techniques to define the better way to define the tumor.


Condition Intervention
Rectal Cancer
 Radiation: Radiation

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Feasibility Study to Compare the Benefits of Endoscopic Tumor Clip Placement and 3T-MRI Simulation for Accurate Target Volume Definition for Rectal Cancer Patients Undergoing Pre-operative Chemoradiation

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Alberta Health Services:

Primary Outcome Measures:
  • To define the usefulness of Endoscopic clip placement and 3T-MRI imaging for accurate target volume definition in rectal cancer patients undergoing pre-operative chemoradiation. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To assess the differences in pelvic lymph node (CTV) volume definition between Ct and MRI images. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 10
Study Start Date: June 2010
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Radiation: Radiation
    No treatment intervention is planned. Patients will be scanned and treated as per department standards. The patient will have MRI at the time of their standard plan. They will then have clips inserted to mark the tumor after the standard scan is performed. The MRI and additional imaging with clips in place will be processed by 3 investigators who will contour based on the experimental image and compare this with the standard treated plan. Comparison of volumes in a blinded manner between investigators will also occur. The patients treatment will not be affected by the MRI or clip placement.
Detailed Description:
  1. The use of endoscopically placed mucosal metal clips to define the superior and inferior extent of the rectal tumor will improve the accuracy of tumor localization in patients undergoing non-contrast CT simulation.
  2. A 3T-MRI will provide a better localization of the rectal tumor and pelvic nodes compared to non-contrast CT simulation for radiotherapy treatment planning.
  3. By comparing these two novel methods to the standard procedure, we would be able to define any difference between the three methods and obtain an estimate of the accuracy and reliability of each method for the localization of the rectal tumor.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with adenocarcinoma of the rectum stage as T3/4 N0/1/2 M0 undergoing pre-operative chemoradiation
  • Patients must be 18 years of age or greater
  • Signed study-specific informed consent
  • Not pregnant or lactating

Exclusion Criteria:

  • Contraindication for radiotherapy or chemoradiation
  • Contraindication for MRI scanning
  • Prior chemotherapy or radiation therapy to the pelvis
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01133340

Contacts
Contact: Diane Severin, MD 780-432-8786 Diane.Severin@albertahealthservices.ca
Contact: Clinical Research Unit clinical_trials_cci@albertahealthservices.ca

Locations
Canada, Alberta
Cross Cancer Institute Recruiting
Edmonton, Alberta, Canada, T6G 1Z2
Contact: Diane Severin, MD     0780-432-8786     Diane.Severin@albertahealthservices.ca    
Contact: Clinical Research Unit         clinical_trials_cci@albertahealthservices.ca    
Principal Investigator: Diane Severin, MD            
Sponsors and Collaborators
Alberta Health Services
IGAR Image guided adaptive radiotherapy
  More Information

No publications provided

Responsible Party: Alberta Health Services
ClinicalTrials.gov Identifier: NCT01133340     History of Changes
Other Study ID Numbers: RECTAL MRI SIM 25409
Study First Received: May 27, 2010
Last Updated: December 10, 2012
Health Authority: Canada: Health Canada

Keywords provided by Alberta Health Services:
RADIOTHERAPY
CT simulation
MRI simulation
 Endoscopic clip placement
Rectal cancer
Accuracy of MRI Simulation for target delineation and planning

Additional relevant MeSH terms:
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
 Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on May 23, 2013