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Personalized Prone Immobilization for Accelerated Partial Breast Radiotherapy

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
40 Years and older
Sex
Female only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests a custom breast holder called VENUS SHELL™ during radiation treatment while lying on the stomach. It checks whether the holder is safe and helps make treatment more accurate, faster, and more comfortable. It is for women age 40 or older with certain small breast cancers who have had surgery that keeps most of the breast.

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

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Sign a consent form before joining or having any study procedures.
  • Have had surgery to remove the cancer while keeping most of the breast.
  • Plan to start radiation treatment within 12 weeks after surgery.
  • Be able to care for yourself and be out of bed or a chair for more than half of waking hours.
  • Be age 40 or older.
  • For invasive cancer, which has grown beyond the milk ducts: have a tumor no larger than 3 cm, with no spread to lymph nodes or distant body parts. If the first nearby lymph node was not tested, there must be no signs of cancer in the nodes on a medical exam.
  • For invasive cancer: have no cancer cells at the outer edge of the tissue removed during surgery.
  • For DCIS, cancer that stays inside the milk ducts: have a tumor no larger than 3 cm and at least 2 mm of cancer-free tissue around the removed tumor.

Who can't join

  • Be male, pregnant, or breastfeeding.
  • Be unable to give consent or follow study instructions, or have a serious health or life situation that could make participation unsafe or difficult.
  • Have breast skin damage, a wound that is not healing, or an infection that could prevent use of the holder.
  • Have a known inherited change in the BRCA1 or BRCA2 gene.
  • Be unable to lie on your stomach or have a CT scan, or have a fear of enclosed spaces.
  • Have a known allergy to medical adhesive patches or acrylonitrile butadiene styrene, a type of plastic.
  • Weigh more than 120 kg, or have breasts that hang down and touch the CT table, leaving too little room for the holder.
  • Have a pacemaker, an implanted heart shock device, or any other electronically active implant.

Simplified for readability. The official criteria below are what the study team uses.

Official 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.

Study sites (1)

NY