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Clinical Trials/NCT00232440
NCT00232440CompletedPhase 1

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

University Health Network, Toronto2 sites in 1 country20 target enrollmentStarted: January 2003Last updated:
Conditions

Trial Snapshot

Phase
Phase 1
Status
Completed
Enrollment
20
Locations
2
Primary Endpoint
The primary outcome for the study is the average deviation in set-up.

Study Overview

Brief Summary

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 Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Outcomes

Primary Outcomes

The primary outcome for the study is the average deviation in set-up.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other

Study Sites (2)

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