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

NCT ID: NCT00232440

Last Updated: 2010-08-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-01-31

Study Completion Date

2009-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Hodgkin's Disease Lymphoma, Non-Hodgkin

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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BodyFIX

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Princess Margaret Hospital, Canada

OTHER

Sponsor Role collaborator

University Health Network, Toronto

OTHER

Sponsor Role lead

Principal Investigators

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Alex Sun, MD

Role: PRINCIPAL_INVESTIGATOR

Princess Margaret Hospital, Canada

Locations

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University Health Network

Toronto, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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UHN REB 02-0526-C

Identifier Type: -

Identifier Source: org_study_id

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