Invasive Breast Cancer Early StagesSHIELDNCT07711847
Personalized Prone Immobilization for Accelerated Partial Breast Radiotherapy
A study testing VENUS SHELL™ immobilization device in people with Invasive Breast Cancer Early Stages and Ductal Carcinoma In Situ, DCIS, run by HeroSupport SA at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 40 years and older, women only
- Conditions the study is for
- Invasive Breast Cancer Early Stages, Ductal Carcinoma In Situ, DCIS
- What is being tested?
- VENUS SHELL™ immobilization device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jul 2026to Jul 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- 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)
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
NYU Grossman School of Medicine
New York, New York, 10016
Lucia Greco, 718-687-8702, lucia.greco@nyulangone.org
Nadia Chowdhury, 347-327-4988, nadia.chowdhury@nyulangone.org
About this study
Official title: Accelerated Partial Breast Radiotherapy Study of a Personalized Holder for Prone Breast Immobilization to Enhance Local Delivery
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:
Read more
- 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
- Being tested
- VENUS SHELL™ immobilization device
- Keywords
- APBI
- Medical subject headings
- Carcinoma, Intraductal, Noninfiltrating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VENUS SHELL™ immobilization deviceDevice
VENUS SHELL™ is used for Accelerated Partial Breast Irradiation
| Study group | Role | What they receive |
|---|---|---|
| VENUS SHELL™ arm | Experimental | VENUS SHELL™ is used for radiotherapy planning and radiotherapy tratment (Accelerated Partial Breast Radiotherapy) Receives: Device: VENUS SHELL™ immobilization device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility outcome: Time (days) between surface scan data received by HeroSupport and arrival of the VENUS SHELL™ at the clinical site
Measured: 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
Measured: Study treatment (10 days)
Safety outcome: number of medical device-related Adverse Events as assessed by CTCAE v5.0
Measured: Through study completion (an average of 3 months)
Secondary outcomes (3)
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).
Measured: 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).
Measured: Study treatment (10 days)
In-vivo dosimetry measured with thermoluminescent dosimeters (TLDs)
Comparison between expected and measured dose to the skin
Measured: Radiotherapy treatment first session, up to last session (10 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2026
- Study start2 Jul 2026
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Invasive Breast Cancer Early StagesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HeroSupport SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University Hospital, Geneva, MDSS
- Responsible party
- Sponsor
- Investigators
- Naamit Gerber, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07711847
- Sponsor's protocol ID
- SHIELD
- Acronym
- SHIELD
- Status last verified
- Jul 2026
- First submitted
- 7 Jul 2026
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes