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Recruiting NCT07711847

Personalized Prone Immobilization for Accelerated Partial Breast Radiotherapy

No phase Interventional Invasive Breast Cancer Early Stages Ductal Carcinoma In Situ, DCIS

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: VENUS SHELL™ immobilization device.
Who it may be relevant to
Registry conditions: Invasive Breast Cancer Early Stages, Ductal Carcinoma In Situ, DCIS. Basic parameters: from 40 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Accelerated Partial Breast Radiotherapy Study of a Personalized Holder for Prone Breast Immobilization to Enhance Local Delivery

Overview

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

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)]
  • 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)]
Secondary outcome measures (3)
  • 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)]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • NYU Grossman School of Medicine — New York

Identifiers

NCT: NCT07711847 · SHIELD

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗