Pilot Study of Microdevice for Evaluating Drug Response in Site in Lung Lesions
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 5
- 试验地点
- 4
- 主要终点
- Number of histopathology analyses and interpretations for drugs eluted from microdevice reservoirs into resected lung lesion tissue.
研究概览
简要总结
This is a pilot study for placement of a tiny microdevice into lung tumors to more precisely predict tumor-specific drug sensitivity, and to help inform systemic therapeutic decisions. The microdevice will provide a novel technique for interrogating human lung tumor tissue in situ, and will uniquely facilitate assessment of response to multiple drugs simultaneously. This will not only increase the specificity of a particular participant's chosen systemic therapy, it will also augment the speed and efficiency with which investigators are able to make clinical decisions regarding choice of therapy.
详细描述
The initial aims in this pilot study will focus on the safety and feasibility of microdevice placement and retrieval in participants with suspicious lung lesions. The microdevice, which is 5.5 mm in length and approximately 750 µm in diameter (i.e., comparable in size and shape to commonly used fiducial markers), will be placed in the suspected tumor tissue at the time of surgical resection. Multiple agents will passively diffuse into local, confined regions (several microns) of the surrounding microenvironment. The agents are released at approximately one millionth of a systemic dose. The device(s) will be removed for analysis at the time of resection, which will be performed for clinical indications independent of enrollment in this study. The investigators will collect data regarding the safety and feasibility of the placement and retrieval of the microdevices, and perform detailed tissue analysis of drug response. Investigators hope to compile preliminary data regarding correlations between in situ drug response and the genetic and histopathologic features of tumors, systemic treatment response, and ultimately, clinical outcomes.
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
- •Patients with a suspicious lung lesion for which surgery is indicated for either diagnostic or therapeutic purposes, as determined by the treating thoracic surgeon
- •Masses with a minimum longest dimension of 1 cm
- •18 years of age or older
- •Documented, signed, dated informed consent for both the surgical resection as well as the proposed research study obtained prior to any procedures
排除标准
- •Subjects who do not wish to undergo surgical resection, or those who are high-risk or not candidates for surgical resection in the opinion of the treating surgeon
- •Women of childbearing potential without a negative pregnancy test; or women who are lactating
结局指标
主要结局
Number of histopathology analyses and interpretations for drugs eluted from microdevice reservoirs into resected lung lesion tissue.
时间窗: 5 years
Feasibility will be based on the ability to retrieve the device with sufficient tissue, of sufficient quality, for downstream histopathology analysis and interpretation of the device reservoirs.
Incidence of treatment-emergent adverse events (safety and feasibility) related to the placement and removal of the microdevice.
时间窗: 5 years
Safety will be measured quantitatively by the number of participants with treatment-related adverse events.
次要结局
- Stratification of local tumoral cellular responses to various agents and combinations of agents released from the microdevice reservoirs.(5 years)
研究者
Oliver Jonas
Co-Investigator, Division of Radiology
Brigham and Women's Hospital