NCT07711847 · HeroSupport SA
Personalized Prone Immobilization for Accelerated Partial Breast Radiotherapy
(SHIELD)
What this study is about
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).
View original scientific description
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).
Interventions
DEVICE
VENUS SHELL™ immobilization device
VENUS SHELL™ is used for Accelerated Partial Breast Irradiation
Primary outcome measures
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)
Performance outcomes: radiotherapy delivered within 15 minutes timeslot and patient positioning accuracy within 2 mm
Time frame: Study treatment (10 days)
Radiotherapy time includes patient positioning and treatment. Patient positioning accuracy is measured though displacement via Tattoos and Image-Guided Radiation Therapy imaging
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)
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- 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
- Unable to lay prone
- Unable to undergo imaging by CT scan
- Documented hypersensitivity or allergy to medical plasters, acrylonitrile butadiene styrene
- Any serious underlying medical, psychiatric, psychological, familial or geographical condition, which in the judgment of the investigator may affect patient compliance or place the patient at high risk within the study.
- Pregnancy or breast feeding
- Claustrophobia
- Patient with a body weight exceeding 120 kg
- Patient with pendulous breasts that come into contact with the CT table, preventing adequate space for shell usage
- Presence of any cardiac implantable electronic device (CIED), including but not limited to a pacemaker, implantable cardioverter-defibrillator (ICD), cardiac resynchronization therapy (CRT) device, or other electronically active implant.
Where
- New York, New York
Collaborators
University Hospital, Geneva, MDSS
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 17, 2026 · Source of record for eligibility and locations