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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
VENUS SHELL™ immobilization device
DeviceVENUS SHELL™ is used for Accelerated Partial Breast Irradiation
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: VENUS SHELL™ armExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Feasibility 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)2
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)3
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)Secondary outcomes
1
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)2
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)3
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)Sponsors and contacts
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Source ClinicalTrials.gov