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

This study has been completed.
Princess Margaret Hospital, Canada
Information provided by:
University Health Network, Toronto Identifier:
First received: October 3, 2005
Last updated: August 10, 2010
Last verified: August 2010

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.

Condition Intervention Phase
Hodgkin's Disease
Lymphoma, Non-Hodgkin
Device: BodyFIX
Phase 1
Phase 2

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 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

Resource links provided by NLM:

Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • The primary outcome for the study is the average deviation in set-up.

Estimated Enrollment: 20
Study Start Date: January 2003
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00232440

Canada, Ontario
University Health Network
Toronto, Ontario, Canada, M5G 2M9
Sponsors and Collaborators
University Health Network, Toronto
Princess Margaret Hospital, Canada
Principal Investigator: Alex Sun, MD Princess Margaret Hospital, Canada
  More Information

No publications provided Identifier: NCT00232440     History of Changes
Other Study ID Numbers: UHN REB 02-0526-C
Study First Received: October 3, 2005
Last Updated: August 10, 2010
Health Authority: Canada: Ethics Review Committee

Additional relevant MeSH terms:
Hodgkin Disease
Lymphoma, Non-Hodgkin
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms by Histologic Type processed this record on November 25, 2015