Accelerated Partial Breast Radiotherapy Study of a Personalized Holder for Prone Breast Immobilization to Enhance Local Delivery
HeroSupport SA
Summary
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
Eligibility
- Age range
- 40+ years
- Sex
- Female
- Healthy volunteers
- No
INCLUSION Criteria: * Written informed consent according to ICH/GCP regulations before registration and prior to any study-specific procedures * Upfront breast conservative surgery * Radiotherapy planned within 12 weeks after surgery * ECOG/WHO performance status ≤2 * Age ≥40 year For invasive breast cancer only: * Staging pT1-T2, N0M0 (Tumor size ≤3 cm) * If no sentinel lymph node biopsy performed, patient must be clinically N0 * Negative margins (no tumor on ink) For ductal carcinoma in situ only: * Staging pTis (tumor size ≤3 cm) * Negative margins (≥2 mm) EXCLUSION Criteria: * Patie…
Interventions
- DeviceVENUS SHELL™ immobilization device
VENUS SHELL™ is used for Accelerated Partial Breast Irradiation
Location
- NYU Grossman School of MedicineNew York, New York