NCT01369420已完成2 期
A Safety Evaluation of the NanoKnife Low Energy Direct Current (LEDC) System in Subjects With Locally Advanced Unresectable Pancreatic Cancer - A Pilot Study
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Safety
研究概览
简要总结
The purpose of this study is to evaluate the safety and feasibility of the NanoKnife Low Energy Direct Current (LEDC) System when used to treat unresectable pancreatic adenocarcinoma. Safety will be reviewed by means of analysis of adverse events, including serious adverse events, laboratory data, physician exam findings, and vital signs.
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
- •male or female
- •>/= 18 years of age
- •meets criteria for locally advanced unresectable pancreatic adenocarcinoma, as radiographically proven pancreatic cancer as determined by a surgical oncologist via pancreatic CT or who were initially thought to be resectable; however at the time of surgery were upstaged to unresectability, via direct visualization
- •tumor size must be < 4 cm and must be measurable
- •must have an INR <1.5
- •must be unresponsive to chemotherapy as demonstrated with either CT or MR imaging and not have taken any chemotherapy agents within 14 days of treatment with the NanoKnife LEDC System
- •are willing and able to comply with the protocol requirements
- •are able to comprehend and willing to sign an Informed Consent Form (ICF)
排除标准
- •a baseline creatinine reported as > 2.0 mg/dL
- •have any reported baseline lab values with a grade 3 or 4 toxicity as defined by the CTCAE Version 3.0
- •inability to stop antiplatelet and Coumadin therapy for 7 days prior to and 7 days post treatment with the NanoKnife System
- •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 immediate 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.
结局指标
主要结局
Safety
时间窗: 90 days
* reported adverse events and adverse effects/events (serious and non serious), * unanticipated adverse events and device complaints, * safety laboratory tests (hematology, chemistry, amylase, lipase), * vital signs, * physical findings (including symptoms, vital signs and weight changes)
次要结局
- Efficacy(90 days)
研究者
研究点 (2)
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