NCT07711847招募中不适用
Accelerated Partial Breast Radiotherapy Study of a Personalized Holder for Prone Breast Immobilization to Enhance Local Delivery
HeroSupport SA1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2026年7月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Feasibility outcome: Time (days) between surface scan data received by HeroSupport and arrival of the VENUS SHELL™ at the clinical site
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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.
结局指标
主要结局
Feasibility outcome: Time (days) between surface scan data received by HeroSupport and arrival of the VENUS SHELL™ at the clinical site
时间窗: Treatment set-up (up to 21 days)
Performance outcomes: radiotherapy delivered within 15 minutes timeslot and patient positioning accuracy within 2 mm
时间窗: Study treatment (10 days)
Radiotherapy time includes patient positioning and treatment. Patient positioning accuracy is measured though displacement via Tattoos and Image-Guided Radiation Therapy imaging
Safety outcome: number of medical device-related Adverse Events as assessed by CTCAE v5.0
时间窗: Through study completion (an average of 3 months)
次要结局
- Patients' comfort (questionnaires)(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)(Study treatment (10 days))
- In-vivo dosimetry measured with thermoluminescent dosimeters (TLDs)(Radiotherapy treatment first session, up to last session (10 days))
研究者
研究点 (1)
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