- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01133340
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
October 1, 2014 updated by: AHS Cancer Control Alberta
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.
Study Overview
Detailed Description
- 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.
- 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.
- 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.
Study Type
Interventional
Enrollment (Actual)
10
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Alberta
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Edmonton, Alberta, Canada, T6G 1Z2
- Cross Cancer Institute
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To assess the differences in pelvic lymph node (CTV) volume definition between Ct and MRI images.
Time Frame: 1 year
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Kurian Joseph, MD, Cross Cancer Institute, Alberta Health Services
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2010
Primary Completion (Actual)
November 1, 2013
Study Completion (Actual)
November 1, 2013
Study Registration Dates
First Submitted
May 27, 2010
First Submitted That Met QC Criteria
May 27, 2010
First Posted (Estimate)
May 28, 2010
Study Record Updates
Last Update Posted (Estimate)
October 2, 2014
Last Update Submitted That Met QC Criteria
October 1, 2014
Last Verified
October 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- RECTAL MRI SIM 25409
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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