The goal of this clinical trial is to find out whether using a personalized breast holder (called VENUS SHELL™) can improve positioning and patient comfort during prone radiotherapy (radiotherapy given while the patient lies on her stomach). The main goals of the study are: * To confirm that using the VENUS SHELL™ is safe and effective * To assess whether the VENUS SHELL™ helps deliver accurate radiation treatment in a faster and more comfortable way Participants will: * Attend a study visit before radiotherapy to have a breast surface scan (no radiation) and enable the production of their personalized VENUS SHELL™ * Use their VENUS SHELL™ during radiotherapy planning and treatment * Be asked to complete questionnaires about their comfort
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
VENUS SHELL™ is used for Accelerated Partial Breast Irradiation
NYU Grossman School of Medicine
New York, New York, United States
RECRUITINGFeasibility outcome: Time (days) between surface scan data received by HeroSupport and arrival of the VENUS SHELL™ at the clinical site
Time frame: Treatment set-up (up to 21 days)
Performance outcomes: radiotherapy delivered within 15 minutes timeslot and patient positioning accuracy within 2 mm
Radiotherapy time includes patient positioning and treatment. Patient positioning accuracy is measured though displacement via Tattoos and Image-Guided Radiation Therapy imaging
Time frame: Study treatment (10 days)
Safety outcome: number of medical device-related Adverse Events as assessed by CTCAE v5.0
Time frame: Through study completion (an average of 3 months)
Patients' comfort (questionnaires)
A first set of questions is rated on a 5-point scale ranging from 1 (strongly disagree) to 5 (strongly agree). A second set of questions is rated on a 4-point scale ranging from 1 (not at all) to 4 (very).
Time frame: Treatment set-up (up to 21 days) and study treatment (10 days)
Evaluate ease of use and overall satisfaction of using the VENUS SHELL (questionnaires)
A set of questions rated on a 5-point scale ranging from 1 (strongly disagree) to 5 (strongly agree).
Time frame: Study treatment (10 days)
In-vivo dosimetry measured with thermoluminescent dosimeters (TLDs)
Comparison between expected and measured dose to the skin
Time frame: Radiotherapy treatment first session, up to last session (10 days)
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