Personalized Prone Immobilization for Accelerated Partial Breast Radiotherapy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age40+
SponsorHeroSupport SA
About this trial
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 criteria
Qualifiers
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
Disqualifiers
Patient of male sex
Inability to obtain informed consent or adhere to the CIP
Breast skin damage that could prevent VENUS SHELL™ usage according to protocol timeline (e.g. presence of any skin or soft tissue wound that failed to show evidence of progression towards healing, clinical signs of active infection at or immediately adjacent to the intended intervention site, etc.)
Known germline BRCA1/2 mutation
Trial design
Treatments tested in this trial
- VENUS SHELL™ immobilization device
Treatment groups
30 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov