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New treatment option for Invasive Breast Cancer Early Stages
Official title Personalized Prone Immobilization for Accelerated Partial Breast Radiotherapy
ClinicalTrials.gov ID: NCT07711847
What this study is testing
- What it's testing
- 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
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 and older, women only
You may be able to join if
- 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:
You likely can't join if
- 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...
- Known germline BRCA1/2 mutation
- Unable to lay prone
- Unable to undergo imaging by CT scan
See the full eligibility 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)
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- New York, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 40 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New York, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.