Resection of Pulmonary Lesions Aided by Robotic Bronchoscopy With Cone CT and INdocyanin Green (REPLACING) Study
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Number of successful procedures out of 50
研究概览
简要总结
This phase II trial studies the use of Ion robotic bronchoscope with a mobile computed tomography (CT) scanner to biopsy tumors and inject a fluorescent dye called indocyanine green to mark the tumor during surgery in patients with stage I non-small cell lung cancer or cancer that has spread to the lung (lung metastases). Sometimes small tumors or those that are not on the surface of the lung can be challenging to remove without making larger incisions. Injecting the dye, may help doctors see the tumor more easily, which may allow for smaller incisions and by being able to see the tumor, doctors may be better able to decide where to make the incisions in order to get all of the tumor out.
详细描述
PRIMARY OBJECTIVE:
I. To evaluate the feasibility of using the Ion Endoluminal Platform (IEP; Intuitive, Sunnyvale, California [CA]) with the Cios Spin - a mobile cone-beam C - (Siemens Medical Solutions, Malvern, Pennsylvania [PA], United States [US]) in the operating room setting.
OUTLINE:
During standard of care surgical resection, patients undergo robotic bronchoscopy and CT. Patients also receive indocyanine green via injection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-80 years
- •Medically operable
- •Undergoing pulmonary resection for either stage I non-small cell lung cancer (NSCLC) (undergoing segmentectomy) or metastatic disease to the lung
- •Lesions < 2cm in longest diameter
- •Lesions are located at least 1cm from the pleura
排除标准
- •Serum creatinine > 2.0
- •Central lesions
- •Iodide allergy
研究组 & 干预措施
Device feasibility (bronchoscopy, CT, indocyanine green)
During standard of care surgical resection, patients undergo robotic bronchoscopy and CT. Patients also receive indocyanine green via injection.
干预措施: Computed Tomography (Procedure)
Device feasibility (bronchoscopy, CT, indocyanine green)
During standard of care surgical resection, patients undergo robotic bronchoscopy and CT. Patients also receive indocyanine green via injection.
干预措施: Indocyanine Green Solution (Drug)
Device feasibility (bronchoscopy, CT, indocyanine green)
During standard of care surgical resection, patients undergo robotic bronchoscopy and CT. Patients also receive indocyanine green via injection.
干预措施: Therapeutic Bronchoscopy (Device)
结局指标
主要结局
Number of successful procedures out of 50
时间窗: through study completion, an average of 1 year
Success is defined as the ability of the provider to navigate to the lesion and deploy the needle into the lesion using the three allotted scans to aid in targeting to the lesion (As evaluated by surgeon using cone beam computed tomography \[CT\]).
次要结局
- Closest margin on resected nodule pathology(Up to 2 years)
- Indocyanine green visualized during robotic pulmonary resection(through study completion, an average of 1 year)
- Number of repositions required to deploy needle into lesion(through study completion, an average of 1 year)
- Presence or absence of diagnostic tissue in sample(Up to 2 years)
- Number of cases that were begun as robotic or video-assisted that were converted to open in order to palpate nodule(through study completion, an average of 1 year)
- Proximity of needle to the lesion on first deployment(through study completion, an average of 1 year)