A Pilot Study of the Safety, Efficacy, and Side Effects of Interventional Cryotherapy for the Eradication of Disease in the Pleural Space ("ICE PLS")
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- To Reduce Tumor Burden in the Pleural Space, as Determined by Visual Inspection and Biopsy of the Treatment Sites 2-5 Days Post Treatment. Safety Endpoint Clinical and Radiographic Status at 30 Days Post CryoSpray Treatment and Adverse Events.
研究概览
简要总结
The purpose of this study is to evaluate the safety, efficacy, and side effects of the CryoSpray Ablation(TM) System (CSA(TM) System) to treat neoplastic lesions on the parietal pleural surface.
详细描述
The proposed study is a pilot study consisting of an estimated 10 subjects with biopsy-proven metastatic cancer in the parietal pleural surface treated with CryoSpray at dye marked metastatic foci.
Initial treatment dosimetry will be up to 3 cycles of 10-40 second sprays. If necessary, dosimetry changes may occur after 3 subjects are treated and observed. It is unknown if dosimetry will need to be increased to enhance effectiveness. The PI may increase dosimetry by 1 cycle after each subject is treated and observed as a conservative approach to efficacy determination. If disease exists bilaterally, only one side will be sprayed.
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
- •18 years of age
- •Deemed a candidate for cryotherapy based on physician physical or medical history review
- •Deemed operable based on institutional criteria
- •Able to sign informed consent
- •Documented lung or other visceral cancer with pleural involvement.
- •WBC > 4,000/mm3, platelets >100,000mm3
- •Physically well enough to undergo moderate sedation and pleuroscopy
- •Female patients must be HCG negative
- •There should be direct evidence of disease progression despite treatment in previously treated patients
排除标准
- •Pregnant or nursing
- •Planning to sire a child while enrolled in the study
- •Known history of unresolved drug or alcohol dependency that would limit ability to comprehend or follow instructions related to informed consent, post-treatment instructions, or follow-up guidelines.
- •Refusal or inability to give consent.
- •Concurrent chemotherapy.
- •Medical contraindication or potential problem that would preclude study participation
- •Concurrent participation in other experimental studies
- •Uncontrolled coagulopathy or bleeding diathesis
- •Serious medical illness, including:
- •Uncontrolled congestive heart failure
- •Uncontrolled angina
- •Myocardial infarction
- •Cerebrovascular accident within 6 months prior to study entry
研究组 & 干预措施
CryoSpray Ablation (TM) System
subjects will receive cryotherapy using the CryoSpray Ablation (TM) System DOSE: up to 3 cycles of 10-40 second sprays
干预措施: CryoSpray Ablation (TM) System (Device)
结局指标
主要结局
To Reduce Tumor Burden in the Pleural Space, as Determined by Visual Inspection and Biopsy of the Treatment Sites 2-5 Days Post Treatment. Safety Endpoint Clinical and Radiographic Status at 30 Days Post CryoSpray Treatment and Adverse Events.
时间窗: 1 year
次要结局
- To Determine if CryoSpray Causes a Pleurodesis Effect. To Determine if CryoSpray Affects Production of Malignant Effusion Within the Treated Pleural Cavity. To Determine if Pleural Cavity Treatment With CryoSpray is Dosimetry Dependent.(1 year)