The Galvanize Therapeutics Early Stage, Non-Small Cell Lung Cancer, Treat and Resect Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 47
- 试验地点
- 4
- 主要终点
- Device and Procedure related serious adverse event rate
研究概览
简要总结
A prospective, two-arm, non-randomized, concurrently controlled, multi-center, open-label, treat and resect study following patients to 1 year. The study is designed to evaluate the safety and feasibility of the Aliya System for the ablation of solid tumors using pulsed electric field (PEF) energy delivery. The study is intended for adult patients with suspected or confirmed NSCLC 8th ed. Stage IA2, IA3 or IB (>1 to ≤4 cm solitary lesion) who are surgical candidates and have not received treatment for the index tumor in the last two years.
详细描述
This study is to evaluate the safety and initial feasibility of Pulsed Electric Field (PEF) treatment of NSCLC tumors prior to surgical resection.
Treatment may be delivered via either an endoluminal (bronchoscopic) or percutaneous approach at the discretion of the clinical investigator utilizing two available device configurations:
- Endoluminal: Galvanize Aliya System with commercially available TBNA Needle (e.g., PeriView FLEX) and RF probe electrode
- Percutaneous: Galvanize Aliya System with compatible commercially available RF needle and RF probe electrode
The study will enroll and treat up to 30 adult patients with early stage NSCLC at up to 5 clinical sites. Patients meeting all eligibility criteria who elect not to undergo the PEF treatment will be offered the opportunity to participate in a concurrent control arm. Up to 10 patients will be included in the control group. A total of up to 40 patients will be included in the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Presence of solitary NSCLC nodule 8th ed. stage IA2, IA3 or IB
- •Nodule measuring > 1 cm and ≤4 cm diameter by CT size estimate (e.g. T1b, T1c, T2a), with a minimum 1 cm solid component
- •High pre-procedure probability of malignancy as determined by the investigator
- •Patient has been evaluated by a thoracic surgeon and deemed a candidate for definitive lung tissue resection
- •Patient is, in the opinion of the principal investigator, able to adhere to and undergo bronchoscopy, surgical procedure and post-treatment care
排除标准
- •Additional pulmonary nodules requiring intervention
- •Patient is receiving concurrent cancer treatment (e.g. external beam radiation therapy, brachytherapy, chemotherapy, targeted therapy, immunotherapy, other focal therapy) or has received treatment for the index tumor in the last two years
- •Patient has implanted lung devices or electronic devices
- •Patient has N1 disease
- •Patient is immune compromised or receiving immune modulating medication
- •Recurrent NSCLC within 2 years of initial definitive treatment
- •Previous checkpoint inhibitor treatment for another cancer
研究组 & 干预措施
Treatment
Patients participating in the treatment group will undergo pulsed electric field (PEF) treatment of a single NSCLC nodule measuring 1 to 4 cm by CT, using the Aliya System. The treatment may be performed endoluminally in conjunction with a diagnostic bronchoscopy, or percutaneously.
干预措施: Pulsed electric field treatment using the Aliya System (Device)
Control
Patients declining to participate in the treatment arm may self-select to participate in an observational control arm.
结局指标
主要结局
Device and Procedure related serious adverse event rate
时间窗: 30 days
The rate of system-related and procedure-related serous adverse events (SAEs)
次要结局
- Technical Success rate(Acute procedure)