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

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators:	University Health Network, Toronto Princess Margaret Hospital, Canada
Information provided by:	University Health Network, Toronto
ClinicalTrials.gov Identifier:	NCT00232440

Purpose

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 I Phase II

MedlinePlus related topics: Hodgkin's Disease Lymphoma

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
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

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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00232440

Locations

Canada, Ontario
University Health Network
Toronto, Ontario, Canada, M5G 2M9

Sponsors and Collaborators

University Health Network, Toronto

Princess Margaret Hospital, Canada

Investigators

Principal Investigator:	Alex Sun, MD	Princess Margaret Hospital, Canada
Principal Investigator:	Alex Sun, MD	Princess Margaret Hospital, Canada

More Information

Study ID Numbers:	UHN REB 02-0526-C
Study First Received:	October 3, 2005
Last Updated:	December 28, 2005
ClinicalTrials.gov Identifier:	NCT00232440
Health Authority:	Canada: Ethics Review Committee

Study placed in the following topic categories:

Lymphatic Diseases
Hodgkin's disease
Immunoproliferative Disorders
Hodgkin lymphoma, adult
Lymphoma, small cleaved-cell, diffuse

Lymphoproliferative Disorders
Lymphoma, Non-Hodgkin
Hodgkin Disease
Lymphoma

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type
Immune System Diseases

ClinicalTrials.gov processed this record on January 16, 2009