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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accelerated Partial Breast Radiotherapy Study of a Personalized Holder for Prone Breast Immobilization to Enhance Local Delivery
- ClinicalTrials.gov ID
- NCT07711847
- Acronym / sponsor ID
- SHIELD / SHIELD
- Keywords
- APBI
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- HeroSupport SAIndustry (pharma, biotech, devices)
- Collaborators
- University Hospital, Geneva, MDSS
- Study start
- 2 Jul 2026 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 17 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VENUS SHELL™ arm | Experimental | Device: VENUS SHELL™ immobilization deviceVENUS SHELL™ is used for radiotherapy planning and radiotherapy tratment (Accelerated Partial Breast Radiotherapy) |
Who may qualify
- Ages
- 40 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VENUS SHELL™ immobilization deviceVENUS SHELL™ is used for Accelerated Partial Breast Irradiation | Device | VENUS SHELL™ arm |
Primary outcome
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)
3 secondary outcomes
Patients' comfort (questionnaires)
Time frame: 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)
Time frame: Study treatment (10 days)
In-vivo dosimetry measured with thermoluminescent dosimeters (TLDs)
Time frame: Radiotherapy treatment first session, up to last session (10 days)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Naamit Gerber, MD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Giovanna Dipasquale (+41(0)783349987, giovanna@herosupport.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2026.