A Pilot Trial of Near Infrared Fluorescence Imaging With Indocyanine Green in the Detection and Diagnosis of Neoplastic Pulmonary Nodules
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Visibility in situ, fluorescence
研究概览
简要总结
This research study will evaluate how Near Infrared Fluorescence imaging (NIFI) with indocyanine green (ICG) contrast dye can assist in the identification and diagnosis of lung nodules during surgery. NIFI is an intraoperative imaging technology that utilizes a coupled camera/fluorophore (ICG) system to fluoresce tissues of interest. Intravenous ICG is a fluorophore with a long-standing high safety profile.
详细描述
This research study is a pilot test of the effectiveness of a near infrared fluorescence imaging (NIFI) system in the detection and diagnosis of pulmonary nodules. Patients selected for enrollment in this study will be adults (≥18 years) that have been scheduled for surgical biopsy and/or resection of a primary lung nodule identified by prior imaging. Patients will receive an injection of indocyanine green (ICG) contrast dye one day prior to their surgery. Intraoperatively, the NIFI system will be used to visualize and characterize the fluorescence patterns given off by these lung nodules, as well as look for additional undiagnosed nodules. These nodules will then be resected and receive histological characterization, as per standard of care. The NIFI system will be evaluated for its ability to 1) visualize nodules and their margins 2) differentiate between benign and malignant nodules and 3) identify additional undiagnosed nodules.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- •Subjects must be willing to undergo surgical biopsy and/or resection of pulmonary nodule(s).
- •Women and men at least 18 years of age
- •Subjects must have a CT scan of the chest within 8 weeks of surgery
排除标准
- •Previous thoracic surgery
- •Inoperable tumor/nodule
- •Unable to tolerate surgery
- •History of allergies to iodides
- •Breast feeding
研究组 & 干预措施
Near Infrared Fluorescence Imaging with Indocyanine Green
Patients will receive an injection of indocyanine green (ICG) 1 day prior to surgery. Near infrared fluorescence imaging (NIFI) will be used to identify pulmonary nodules during the surgical biopsy and/or resection procedure.
干预措施: near infrared fluorescence imaging (NIFI) (Device)
Near Infrared Fluorescence Imaging with Indocyanine Green
Patients will receive an injection of indocyanine green (ICG) 1 day prior to surgery. Near infrared fluorescence imaging (NIFI) will be used to identify pulmonary nodules during the surgical biopsy and/or resection procedure.
干预措施: Indocyanine Green (Drug)
结局指标
主要结局
Visibility in situ, fluorescence
时间窗: Through study completion, an average of one year
Nodule malignancy
时间窗: Through study completion, an average of one year
Visibility in situ, white light
时间窗: Through study completion, an average of one year
次要结局
- Visibility ex vivo, white light(Through study completion, an average of one year)
- Visibility ex vivo, fluorescence(Through study completion, an average of one year)
研究者
Inderpal Sarkaria, MD
MD
University of Pittsburgh