To Investigate the Safety of the CAROL Device for Lung Tumour Treatment in Patients With Non-small Cell Lung Cancer Tumours(s) ≤ 2 cm (cT1b)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Common Terminology Criteria for Adverse Events(CTCAE)
研究概览
简要总结
This study aims to evaluate the safety of the CAROL device for treating lung tumors in patients diagnosed with non-small cell lung cancer (NSCLC) with tumor size ≤ 2 cm (cT1b). The primary objective is to assess safety by monitoring and grading adverse events using the CTCAE v5.0 criteria at one month following the procedure.
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
- •Those who meet all the following criteria are eligible to participate in the clinical trial.
- •Adults 18 years of age or older at the time of screening
- •NSCLC tumour(s)≤ 2 cm (cT1b) suitable for resection
- •Suitable candidate for resection per standard of practice (Lobectomy)
- •NSCLC is confirmed pathologically for the tissue that will be ablated
- •Location of tumour:
- •① in outer one thirds of lung (between outermost 1/3 measured by tumour centre),
- •② if the centre of the tumour is located within the outermost 1/3, inclusion will proceed,
- •③ anticipation that resection (lobectomy) would remove all gross tumour and ablation with grossly negative margins,
- •④ one or more radiofrequency ablation (RFA) applications would target entire margin according to the RFA plan
- •Signed free and informed consent as prescribed by hospital policies.
排除标准
- •Those who meet any of the following criteria are excluded from this clinical trial.
- •Centralised tumour (inner most one third) not amenable to resection (abutting main stem bronchus, main pulmonary artery branches, oesophagus or trachea)
- •Other primary lung tumours
- •Tumour is associated with vulnerable zone of pleural effusion
- •If the centre of the tumour is not located within the outermost 1/3, exclusion will proceed
- •PFT: post-bronchodilator forced expired volume in on second (FEV1) or forced vital capacity (FVC) ≤60% predicted, diffusing capacity of the lung for carbon monoxide (DLCO) ≤ 50% predicted
- •Patients with evidence of severe chronic pulmonary disease including asthma, Chronic Obstructive Pulmonary Disease (COPD), or Interstitial Lung Disease (ILD).
- •Requirement of supplemental oxygen at rest or exercise
- •Hospitalization for cardiac disease within the preceding 3 months
- •Liver enzymes (Alanine Aminotransferase [ALT], Alkaline Phosphatase [ALP], Aspartate Aminotransferase [AST]) or total bilirubin >1.5 upper limit of normal (ULN)
- •Serum creatinine > 2 mg/dl
- •Recent infection (within 30 days)
- •Receiving immunosuppressive medication or prednisone > 20 mg/day (or equivalent)
- •Pre-existing implants - either within the airways or any other location - that impede navigation to or visualisation of the target lesion, in the opinion of the investigator
- •Pregnant or breastfeeding women and those of childbearing potential who are not practicing a reliable form of contraception.
- •Disorder of coagulation, history of severe haemoptysis, or receiving anticoagulant medication. Antiplatelet medication is permitted provided that the medication can be held a minimum of 7 days prior to the procedures and 10 days post-procedures, where this refers to both the ablation and surgical procedures
- •Any condition or anatomical factor that, in the opinion of the investigator or reviewer, may interfere with the safety of the patient, the conduct of the procedure, or evaluation of the study objectives (e.g. severe bronchial narrowing, wall compromise)
- •Any tumour characteristic that in the opinion of the investigator or reviewers may interfere with the safety of the patient or evaluation of the study objectives
- •Contraindication to complete neuromuscular blockade during the ablation procedure
- •Implantable cardiac devices such as pacemakers or defibrillators, especially with unipolar electrode configurations
- •Known hypersensitivity or allergy to gallium, indium, or other components of the conformable electrode
- •Medically inoperable conditions
- •Participant who is currently participating in, or planning to participate in (during the course of the trial), another non-observational clinical research study
- •Participants who have participated in a non-observational clinical research study within either the past 30 days or who are still within the intervention's wash-out period (whichever is longer)
- •Participant who, in the opinion of the investigator, is not suitable for participation in the study
研究组 & 干预措施
CAROL Device Treatment for Early-Stage NSCLC
Participants in this single-arm study will undergo treatment with the CAROL device for localized lung tumors (NSCLC ≤ 2 cm, cT1b). All participants will receive a single CAROL procedure using a conformable electrode, followed by surgical resection of the tumor.
The first 3 sentinel participants will receive a maximum dose of 0.3 mL of the conformable electrode. The next 4 participants will receive up to 2.0 mL. Safety and preliminary efficacy will be assessed through scheduled follow-up visits, including imaging, pulmonary function testing, laboratory assessments and pain monitoring.
Adverse events will be monitored throughout the study, with grading based on CTCAE v5.0, specifically focusing on "Respiratory, thoracic, and mediastinal disorders." The study includes visits at screening, pre-procedure, post-procedure (24-36 hours), pre- and post-resection, and follow-up at approximately one and three months.
干预措施: CAROL NSCLC treatment Device (Device)
结局指标
主要结局
Common Terminology Criteria for Adverse Events(CTCAE)
时间窗: 1 month post-procedure
Graded using CTCAE grade (v5.0) criteria(CTCAE) The CTCAE utilizes a scale ranging from Grade 1 (mild) to Grade 5 (death-related) to classify the severity of adverse events. A higher CTCAE grade indicates increased severity of the adverse event, signifying a worse outcome.
次要结局
- Device success(Immediately after application (measured by imaging during the procedure))
- Procedural success(2~9 days after the CAROL procedure)
- Procedural success(Immediately after procedure (intraoperative and early postoperative period))
- Procedural success(5 ~ 10 days after lung resection)