A Feasibility and Safety Study of Intratumoral Diffusing Alpha Radiation Emitters for the Treatment of Recurrent Lung Cancer
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
- Safety- Adverse events
研究概览
简要总结
A unique approach for cancer treatment employing intratumoral diffusing alpha radiation emitter device for treatment of recurrent Lung Cancer .
详细描述
This is a prospective , interventional, open label, single arm, single center study.
The study is designed to evaluate the Feasibility and Safety of DaRT seeds for the treatment of Recurrent Lung Cancer. 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 3 months. The total duration of the study will be 3 months from the DaRT insertion procedure.
A total of 10 subjects will be enrolled to the 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 3 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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically and/or cytologically proven recurrent mediastinal tumors
- •Target lesion is technically amenable for at least 50% coverage by the Alpha DaRT seeds as determined by the treating physician
- •Up to two treatable lesions
- •Interstitial radiation indication validated by a multidisciplinary team.
- •Measurable lesion per RECIST (version 1.1) criteria
- •Lesion size ≤ 3 cm in the longest diameter
- •Age ≥18 years old
- •ECOG Performance Status Scale ≤ 3
- •Life expectancy is more than 6 months
- •WBC ≥ 3500/µl, granulocyte ≥ 1500/µl
- •Platelet count ≥60,000/µl
- •Calculated or measured creatinine clearance ≥ 60cc/min. Calculated, or measured creatinine clearance can be≥ 40cc/min given stability of creatinine levels over the past three weeks (at least 1 test per week).
- •AST and ALT ≤ 2.5 X ULN
- •INR < 1.4 for patients not on Warfarin
- •Subjects are willing and able to sign an informed consent form
- •Women of childbearing potential (WOCBP) will have evidence of negative pregnancy test before the Ra-224 implantation and are required to use an acceptable contraceptive method to prevent pregnancy for 3 months after brachytherapy.
排除标准
- •Concomitant chemotherapy or immunotherapy
- •Brain metastases Connective tissue disease (scleroderma, lupus)
- •Known hypersensitivity to any of the components of the treatment.
- •Patients undergoing systemic immunosuppressive therapy excepting intermittent, brief use of systemic corticosteroids.
- •Clinically significant cardiovascular disease, e.g. cardiac failure of New York Heart Association classes III-IV, uncontrolled coronary artery disease, cardiomyopathy, uncontrolled arrhythmia, uncontrolled hypertension, or history of myocardial infarction in the last 12 months.
- •Patients with uncontrolled intercurrent illnesses including, but not limited to an active infection requiring systemic therapy or a known psychiatric or substance abuse disorder(s) that would interfere with cooperation with the requirements of the trial or interfere with the study endpoints.
- •Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.
- •Patient requires treatment not specified in this protocol which may conflict with the endpoints of this study including evaluation of response or toxicity of DaRT.
- •Patients must agree to use adequate contraception (vasectomy or barrier method of birth control) prior to study entry, for the duration of study participation and for 3 months after discontinuing therapy.
- •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).
- •Breastfeeding women or women of childbearing potential unwilling or unable to use an acceptable contraceptive method to prevent pregnancy for 3 months after RT.
研究组 & 干预措施
DaRT Seeds
Intratumoral Diffusing alpha-emitters Radiation Therapy (DaRT) Seed
干预措施: Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT) (Device)
结局指标
主要结局
Safety- Adverse events
时间窗: From Day 0-Day 90
Safety will be determined according to the overall incidence of device related SAE's graded according to CTCAE v5.0 criteria
Feasibility - DaRT seed placement
时间窗: From Day 0-Day 90
Feasibility will be determined according to the rate of successful placement of DaRT seeds via imaging
次要结局
- Efficacy - Alpha DaRT seeds(Day 0-Day 90)