Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107, United States
NCT Number: NCT00328510
Fractionated stereotactic radiotherapy (SRT) requires extremely precise and reproducible immobilization of the patient's head. This randomized study compares the efficacy of two commonly used forms of immobilization used for SRT.
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Notify Me18 year and older
All sexes
Interventional
Phase 3
Philadelphia, Pennsylvania, 19107, United States
PRIMARY OBJECTIVE:
OUTLINE:
Two routinely used methods of immobilization, which differ in their approach to reproduce head position from day-to-day are the Gill-Thomas-Cosman (GTC)frame and the BrainLab thermoplastic mask. The GTC frame fixates on the patient upper detention and thus us in direct mechanical contact with the cranium. The BrainLab mask is a two-part masking system custom-fitted to the front and back of the participant's head. After patients sign an IRB-approved informed consent form, eligible participants are either randomized to either the GTC frame or the mask for their course of SRT. Participants are treated as per standard procedure; however, prior to each treatment, a set of digital kV images (ExacTrac, BrainLabAB, Germany) is taken. These images are fused with reference digitally constructed radiographs obtained from treatment planning CT to yield lateral, longitudinal, and vertical deviations of isocenter and head rotations about respective axes. The primary endpoint of the study is to compare the two systems with respect to mean and standard deviations (SDs) using the distance to isocenter measure.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Other names: SRT
Time frame: Measurements taken during SRT
This study uses the ExacTRAC imaging system to assess positioning of frame or mask during SRT. Images yield lateral, longitudinal, and vertical deviations of the isocenter as well as head rotations about respective axes.
Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
Other
A Randomized Trial Comparing Two Forms of Immobilization of the Head for Fractioned Stereotactic Radiotherapy
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