A Pilot Feasibility and Safety Trial of Intratumoral Diffusing Alpha-emitter Radiation Therapy (DaRT) for the Treatment of Newly Diagnosed or Recurrent Breast Carcinoma in Frail or Elderly Patients.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Feasibility -DaRT seed placement
研究概览
简要总结
A unique approach for cancer treatment employing intratumoral diffusing alpha radiation emitter device for the treatment of newly diagnosed or Recurrent Breast Carcinoma in frail or elderly patients.
详细描述
This is a Prospective Open label Single arm multi-center interventional study. The study is designed to evaluate the Feasibility and Safety of DaRT seeds for the treatment of newly diagnosed or Recurrent Breast Carcinoma in frail or elderly patients.
The study will be comprised of a screening period, DaRT insertion visit, acute follow-up phase of 4- 8 weeks and a long-term follow up phase of 24 months. The total duration of the study will be 24 months from the DaRT insertion procedure.
A total of 10 subjects will be enrolled from all breast cancer subtypes (HR+/HER-2-, HR+/HER-2+, HR-/HER-2-, and HR-/HER-2-.). No formal interim analysis is planned for this study.
Eligible patients who meet inclusion/exclusion criteria (as assessed during the screening period) will be invited to the site for the procedure of DaRT seeds insertion. The patients will be monitored for a period of 24 months post insertion
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
- 65 Years 至 120 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed invasive breast tumor with no involvement of skin within 12 months.
- •Tumor size ≤ 4 centimeters in the longest diameter.
- •Tumor is not deemed as resectable with radical surgery or the patient does not wish to go through surgery
- •De-novo or recurrent lesions.
- •Single lesion per quadrant per subject.
- •Targeted lesion must be technically amenable for complete coverage (including margins) by the DaRT seeds.
- •Interstitial implant indication validated by multidisciplinary team.
- •ECOG Performance Status ≤
- •Life expectancy ≥12 months.
- •Women Age ≥65 or younger if unfit for standard of care.
- •Willing and have the ability to provide signed Informed Consent.
- •Blood tests values:
- •Leucocytes ≥3000mm3,
- •Absolute neutrophil count ≥1500mm3,
- •Platelets ≥100,000 mm3,
- •Total bilirubin ≤ 1.5xULN,
- •AST, SGOT, SGPT ≤2.5xULN, If Alkaline Phosphatase ≤ 4xULN, then transaminases are normal.
- •Creatinine ≤ 2.0xULN.
- •INR or Prothrombin time ≤1.5xULN
排除标准
- •T4 category with skin involvement.
- •Ductal carcinoma in situ.
- •Inflammatory breast carcinoma.
- •Longest tumor diameter >4 cm.
- •Patients with prior radiation to the same area within the past 6 months.
- •Has a known additional malignancy that is progressing or requires active treatment.
- •Patients undergoing immunosuppressive and/or systemic corticosteroid treatment except for steroid inhalations for treatment of asthma or lung disease
- •Subjects not willing to sign an informed consent.
结局指标
主要结局
Feasibility -DaRT seed placement
时间窗: immediately following the insertion procedure
Feasibility will be determined according to the Rate of successful placement of DaRT seeds via imaging
Safety- Adverse events
时间窗: From Day 0
Safety will be determined according to the overall incidence of device related SAE'sgraded according to CTCAE v5.0 criteria
次要结局
- Efficacy - Control evaluation(3,6,12 and 24 months)