Reproducibility of an Immobilization Device (BodyFIX) - Hodgkins/Lymphoma

Lymphoma, Non-Hodgkin Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00232440
• Other study ID #: UHN REB 02-0526-C
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: October 3, 2005
• Last updated: August 10, 2010
• Start date: January 2003
• Est. completion date: June 2009

Study information

• Verified date: August 2010
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hodgkin Disease
• Hodgkin's Disease
• Lymphoma
• Lymphoma, Non-Hodgkin

Intervention

Device:
• BodyFIX

Locations

Country	Name	City	State
Canada	University Health Network	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
University Health Network, Toronto	Princess Margaret Hospital, Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome for the study is the average deviation in set-up.