Personalized Prone Immobilization for Accelerated Partial Breast Radiotherapy

Conditions

• Ductal Carcinoma In Situ, DCIS
• Invasive Breast Cancer Early Stages

Eligibility Criteria

Sex

FEMALE

Age

40 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• VENUS SHELL™ immobilization device — DEVICE
  VENUS SHELL™ is used for Accelerated Partial Breast Irradiation

Study Details

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

Key Dates

First listed

Jul 17, 2026

Start date

Jul 31, 2026

Status verified

Jul 2026

Primary completion

Jul 31, 2027

Completion

Jul 31, 2027

Study Design

Enrollment

30 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: VENUS SHELL™ arm
  VENUS SHELL™ is used for radiotherapy planning and radiotherapy tratment (Accelerated Partial Breast Radiotherapy)

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) ]

Central Contacts

• Giovanna Dipasquale
  +41(0)783349987
  [email protected]
• Cristina Riccadonna
  +41(0)223794650
  [email protected]

Locations (1)

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