Phase II Real-Time NIR-Guided Sentinel Lymph Node Mapping in Breast Cancer
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Sensitivity of Real-Time Intraoperative NIR Mapping
研究概览
简要总结
The objective of this Phase II study is to assess the diagnostic accuracy of sentinel lymph node (SLN) identification in patients with breast cancer using near-infrared (NIR) fluorescence optical imaging.
详细描述
Fifty participants consented from Brigham and Women's Hospital (currently enrolling) and Beth Israel Deaconess Medical Center (currently non-enrolling), who will be undergoing standard of care for breast cancer SLN mapping with Tc-99m will be enrolled in this study.
Prior to surgery, patients will undergo lymphoscintigraphy as is standard of care. At the time of SLN mapping, the patient will be injected with indocyanine green dye (ICG). Concurrently, a custom-designed imaging platform that utilizes NIR fluorescence optics will be employed to identify the dye and its path through the lymphatic track, and its eventual highlighting of the SLN. Both color images and NIR images will be merged to give the operating surgeon a clear picture of the ICG track superimposed over anatomical landmarks. This technique will identify the SLN and provide an accurate video image of its location. The surgeon will resect all SLNs identified by Tc-99m or NIR fluorescence, and then confirm the radioactivity and NIR fluorescence signal in each after resection.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Participant must have histologically confirmed breast cancer and be deemed an appropriate surgical candidate with consent for a sentinel lymph node mapping by their oncologic surgeon.
- •Age minimum: 18 years.
- •Participant must be receiving a planned lymphoscintigraphy procedure.
- •Participant must have the ability to understand and the willingness to sign a written informed consent document.
排除标准
- •Participants who choose not to proceed with sentinel lymph node biopsy.
- •History of allergic reactions attributed to compounds of similar chemical or biologic composition to indocyanine green, including those patients with a history of iodide or seafood allergy.
- •Women who are pregnant or may become pregnant, as well as those women who are breastfeeding, will be excluded from this study.
结局指标
主要结局
Sensitivity of Real-Time Intraoperative NIR Mapping
时间窗: One Day (day 1)
To determine the sensitivity of real-time intraoperative NIR lymphatic mapping in the identification of the sentinel lymph node in human breast cancer as compared to the standard of care, Technicium 99 (Tc-99).
次要结局
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability(One Day (day 1))
研究者
John V. Frangioni
Principal Investigator
Beth Israel Deaconess Medical Center