RecruitingNot Applicable

Personalized Prone Immobilization for Accelerated Partial Breast Radiotherapy

United States30 participantsStarted 2026-07

Plain-language 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). 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

Who can participate

Age range

40 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 pend…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Feasibility outcome: Time (days) between surface scan data received by HeroSupport and arrival of the VENUS SHELL™ at the clinical site

Timeframe: Treatment set-up (up to 21 days)

Performance outcomes: radiotherapy delivered within 15 minutes timeslot and patient positioning accuracy within 2 mm

Timeframe: Study treatment (10 days)

Safety outcome: number of medical device-related Adverse Events as assessed by CTCAE v5.0

Timeframe: Through study completion (an average of 3 months)

Trial details

NCT IDNCT07711847

SponsorHeroSupport SA

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-07

Contact for this trial

Giovanna Dipasquale

+41(0)783349987 giovanna@herosupport.ch

View on ClinicalTrials.gov More Invasive Breast Cancer Early Stages trials