A Safety and Effectiveness Study of Intratumoral Diffusing Alpha Radiation Emitters for the Treatment of Malignant Cutaneous Tumors
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 4
- 主要终点
- The objective response rate to DaRT treatment
研究概览
简要总结
A unique approach for cancer treatment employing intratumoral diffusing alpha radiation emitter device for Malignant Cutaneous Tumors
详细描述
This will be a prospective, open label, single arm, multi- center study, assessing the safety and effectiveness of diffusing alpha emitters radiation therapy (DaRT) delivered through radioactive seeds inserted into the tumor.
This approach combines the advantages of local intratumoral irradiation of the tumor, as used in conventional brachytherapy, with the power of the alpha radiation emitting atoms, that will be introduced in quantities considerably lower than radiation therapy already used in patients.
Cutaneous lesions with histopathological confirmation of malignancy will be treated using DaRT seeds.
Reduction in tumor size 9-11 weeks following DaRT insertion will be assessed. Safety will be assessed by the frequency, severity and causality of all Adverse Events (AE).
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with histopathological confirmation of newly diagnosed (Cohort A) or locally recurrent (Cohort B) malignant cutaneous lesions of the following histopathologies:
- •Lentigo maligna melanoma (Dubreuilh melanoma)
- •Carcinosarcoma
- •Acceptable tumor locations include the following:
- •Skin (facial, scalp, extremities, torso)
- •Subjects with a tumor size ≤ 7 centimeters in the longest diameter.
- •Target lesion technically amenable for full tumor coverage with the Alpha DaRT seeds.
- •Measurable disease according to RECIST v1.
- •Subjects over 18 years old.
- •Subjects' ECOG Performance Status Scale is <
- •Subjects' life expectancy is more than 6 months.
- •Platelet count ≥100,000/mm
- •International normalized ratio of prothrombin time ≤1.
- •Women of childbearing potential (WOCBP) will have evidence of negative pregnancy test.
- •Subjects are willing to sign an informed consent form
排除标准
- •Subject has a tumor with histology of one of the following:
- •Keratoacanthoma
- •Merkel cell carcinoma
- •Sarcoma other than carcinosarcoma
- •Metastatic disease (according to the TNM staging system - M1 patients are excluded)
- •Patients with significant comorbidities that the treating physician deems may conflict with the endpoints of the study (e.g., poorly controlled autoimmune diseases, vasculitis, etc.).
- •Patients undergoing systemic immunosuppressive therapy excepting intermittent, brief use of systemic corticosteroids.
- •Volunteers participating in another interventional study in the past 30 days which might conflict with the endpoints of this study or the evaluation of response or toxicity of DaRT.
- •High probability of protocol non-compliance (in opinion of investigator).
- •Subjects not willing to sign an informed consent.
- •Women who are pregnant or breastfeeding.
研究组 & 干预措施
DaRT Seeds Intratumoral Diffusing alpha-emitters
An intratumoral insertion of securely fixed seeds loaded with Radium-224. The seeds release by recoil short-lived alpha-emitting atoms into the tumor.
干预措施: DaRT- Diffusing Alpha-emitters Radiation Therapy (Device)
结局指标
主要结局
The objective response rate to DaRT treatment
时间窗: up to 9-11 weeks
Assessment of tumor response rate using the Response Evaluation Criteria in Solid Tumors (RECIST) (Version 1.1)
次要结局
- DaRT seeds placement(Day of DaRT insertion procedure)
- Change in quality of life as assessed by the Skin Cancer Index (SCI) questionnaire(up to 9-11 weeks)
- Tumor volume(up to 9-11 weeks)
- Disease-Free Survival (DFS) rate(up to 24 months)
- Change in quality of life as assessed by the Skindex-16 questionnaire(up to 9-11 weeks)