Outcomes of Ablation of Unresectable Pancreatic Cancer Using the NanoKnife Irreversible Electroporation (IRE) System
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Safety and Pain
研究概览
简要总结
The purpose of this study is to evaluate the short and intermediate term safety of the NanoKnife Irreversible Electroporation System when used off-label to treat unresectable pancreatic cancer. In addition, the study will evaluate the efficacy of this device in treating pain associated with unresectable pancreatic cancer. Quality of life post-procedure will also be collected.
详细描述
The NanoKnife, System has been commercially available since 2009, and is FDA-approved to treat soft tissue tumors. The NanoKnife System has received FDA clearance for the surgical ablation of soft tissue. It has not received clearance for the therapy or treatment of any specific disease or condition.
The purpose of this study is to evaluate the short and intermediate term safety of the NanoKnife Irreversible Electroporation System when used off-label to treat unresectable pancreatic cancer. In addition, the study will evaluate the efficacy of this device in treating pain associated with unresectable pancreatic cancer. Quality of life post-procedure will also be collected.
Primary Objective:
• Safety and tolerability of the procedure by monitoring the number of participants with Adverse Events at the following time points: 1, 2, 4, 7, 14, 21 and 30 days and 3, 6, 9, 12, 15, 18, 21, and 24 months post-IRE procedure.
Secondary Objective:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •> = 18 years of age
- •Must be found to have locally advanced unresectable disease following standard chemotherapy ± radiotherapy as demonstrated with either CT/MRI imaging and surgical evaluation, and not have taken any chemotherapy/radiotherapy within 5 weeks of treatment with the NanoKnife IRE System
- •Must have an INR < 1.5
- •Are willing and able to comply with the protocol requirements
- •Are able to comprehend and willing to sign an informed consent form
排除标准
- •Creatinine > 2.0 mg/dL
- •Any lab value with a grade 3 or 4 toxicity as defined by the CTCAE Version 5.0
- •Inability to stop antiplatelet and coumadin therapy for 7 days prior to and 7 days post treatment with the NanoKnife System
- •Tumor size not measurable
- •Known history of contrast allergy that cannot be medically managed
- •Known hypersensitivity to the metal in the electrodes (stainless steel 304L) that cannot be medically managed
- •Unable to be treated with a muscle blockade agent (e.g. pancuronium bromide, atracurium, cisatracurium, etc.)
- •Women who are pregnant or currently breast feeding
- •Women of childbearing potential who are not utilizing an acceptable method of contraception
- •Have taken an investigational agent within 30 days of visit 1
- •Have implanted cardiac pacemakers or defibrillators
- •Have implanted electronic devices or implants with metal parts in the vicinity of a lesion
- •Have a history of epilepsy or cardiac arrhythmia (atrial or ventricular fibrillation)
- •Have a recent history of myocardial infarction (within the past 2 months)
- •Have Q-T intervals greater than 550 ms unless treated with an Accysync Model 72 synchronization system controlling the NanoKnife system's output pulses
- •Evidence of distant metastases of stage IV
- •Have taken any chemotherapeutic agent within 5 weeks of treatment with the NanoKnife Irreversible Electroporation (IRE) System
- •Received non-conventional fractionation schedules, such as stereotactic radiation (5 fractions or less) or received higher than 54 Gray (Gy) delivered conventionally
结局指标
主要结局
Safety and Pain
时间窗: 2 years
Safety and tolerability of the procedure by monitoring the number of participants with Adverse Events at the following time points: 1, 2, 4, 7, 14, 21 and 30 days and 3, 6, 9, 12, 15, 18, 21, and 24 months post-IRE procedure. The primary endpoint will be the number of Participants with an adverse event related to the IRE treatment and serious or non-serious, at least grade 3, at least possibly related to treatment This will be measured by a series of questionnaires on pain scores via Quality of Life scores via the EORTC QLQ-PAN26 and EORTC QLQ-C30. Pain will be measured on a scale from 0-10, with 0 being no pain and 10 being worst pain.
次要结局
未报告次要终点