Pilot Study Evaluating the Effects of Intrapleural Cryotherapy on Tumor Infiltrating Lymphocytes in Malignant Pleural Mesothelioma Using Cryospray Therapy
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Mayo Clinic
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Number of Participants with Adverse Events
研究概览
简要总结
Can neoadjuvant intrapleural cryotherapy be safely performed in patients with malignant pleural mesothelioma and will it trigger substantial systemic and local pro-inflammatory changes, resulting in the induction of anti-tumor immunity?
详细描述
Patients that have been diagnosed, or are suspected of having malignant pleural mesothelioma, a cancer of the pleura, surgery may be considered as an attempt to treat the cancer. As part of the testing needed before surgery, a pleuroscopy or video camera examination of the pleura is necessary to establish the diagnosis and/or to evaluate the extent of the cancer. This study evaluates the effects of cryotherapy (freezing spray) on the ability of a patient's immune system to attack the cancer, as has been reported in other types of cancers. The purpose of this research is to gather information on the safety and effectiveness of cryotherapy in patients with malignant pleural mesothelioma. If successful, this study could provide support for future studies evaluating this new treatment for mesothelioma.
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
- •Subject provides informed consent
- •Subject is >18 years of age
- •Subject is deemed competent for making medical decisions
- •Subject is scheduled to undergo pleuroscopy as part of their standard care for pre-operative clinical staging of malignant pleural mesothelioma
- •A negative pregnancy test is required in women of child-bearing potential, as standard of care.
- •Subject is mentally capable of understanding study procedures.
排除标准
- •Study subject has any disease or condition that interferes with safe completion of the study including:
- •Platelet count < 50K, coagulopathy defined as an International Normalized Ratio (INR) > 1.5
- •Anticoagulants such as clopidogrel, heparin, low-molecular weight heparin, warfarin or other novel anticoagulants have not been held for the standard time period published
- •Hemodynamic instability with systolic blood pressure <90 mmHg or heart rate > 120 beats/min, unless deemed to be stable with these values by the surgical or interventional pulmonary attending physicians.
- •Hypoxemia with pulse oximetry values <88% or partial pressure of oxygen in arterial blood (PaO2) < 60 on baseline oxygen requirements.
- •Concurrent participation in another study involving investigational drugs or investigational medical devices
- •Absence of or limited access to the pleural space during medical pleuroscopy.
- •Inability to read and understand the necessary study documents.
研究组 & 干预措施
Cryotherapy
Cryospray and biopsies
干预措施: Cryotherapy (Procedure)
Control
Biopsies
干预措施: Control (Other)
结局指标
主要结局
Number of Participants with Adverse Events
时间窗: 1 month
Participants will be monitored for any adverse events that may have resulted from the pleuroscopy procedure.
Mean Number of Tumor Infiltrating Immune Cells as Measured by Immunohistochemistry on Participant Tissue Samples
时间窗: 14 days
次要结局
未报告次要终点