- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00232440
Reproducibility of an Immobilization Device (BodyFIX) - Hodgkins/Lymphoma
A Study to Examine the Reproducibility of an Immobilization Device (BodyFIX ) to Deliver High Precision Radiation Therapy for Patients With Hodgkin's Disease or Non-Hodgkin's Lymphoma
Radiation therapy has a well-established role in the treatment of Hodgkin's Disease and non-Hodgkin's Lymphoma. With technological developments, 3-D Dimensional (3D) planning has evolved as a highly precise treatment planning option. High-precision radiation therapy has the potential for more accurate dose delivery to the tumour volume and can result in a greater sparing of normal tissue. An important component of safe radiotherapy delivery is the feasibility and reproducibility of current and new immobilization devices for highly conformal treatment.
The purpose of this study is to determine the reproducibility of an immobilization device known as BodyFIX(TM) using conventional treatment techniques.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
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Ontario
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Toronto, Ontario, Canada, M5G 2M9
- University Health Network
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- All patients undergoing curative or palliative treatment in whom it is considered that immobilization of part or all of an anatomical region would be of benefit to their care.
Exclusion Criteria:
- Any case where ideal treatment may be compromised with use of immobilization method.
- If the patient has any social issues, language barriers resulting in difficulties comprehending the nature of the study, or poor performance status, that could compromise compliance with the study guidelines.
Study Plan
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 |
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The primary outcome for the study is the average deviation in set-up.
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Alex Sun, MD, Princess Margaret Hospital, Canada
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UHN REB 02-0526-C
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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Clinical Trials on BodyFIX
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