Validation of Augmented-Reality/Virtual-Reality Goggle-Based Near-Infrared Fluorescence Imaging for Sentinel Lymph Node Detection in Patients With Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Node-level diagnostic accuracy of AR-ICG fluorescence imaging versus histopathology
研究概览
简要总结
This study evaluates how accurately augmented-reality goggles with indocyanine green (ICG) near-infrared fluorescence can identify sentinel (first-draining) lymph nodes during breast cancer surgery. The goggles and ICG signal are used to mark candidate sentinel nodes, and an additional observer may record near-infrared images during the operation for device-performance assessment. These imaging findings do not change the surgical procedure. The candidate nodes and all removed tissue are examined by histopathology, which serves as the reference standard. Two hundred patients undergoing breast cancer surgery will take part. The study measures how well the goggle-based imaging detects nodes that contain cancer, compared with final pathology.
详细描述
This is a prospective observational device-validation study in patients undergoing breast cancer surgery with axillary evaluation. Augmented-reality goggle-based near-infrared fluorescence imaging with ICG is used to visualize and mark candidate sentinel lymph nodes. Intraoperative near-infrared imaging may be performed by an observer who is not the operating surgeon, solely to assess device performance; observer findings are not communicated to the operating surgeon before wound closure and do not influence the operation. All marked nodes and removed tissue undergo histopathology, which serves as the blinded reference standard. Device performance is assessed on consecutive eligible patients within defined enrollment windows; for each near-infrared imaging device, sensitivity, specificity, positive and negative predictive value, and node-level ROC analysis are estimated against final histopathology, with confidence intervals accounting for clustering of nodes within patients. The study is non-interventional: the imaging does not alter surgical management.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Histologically proven breast cancer
- •Age 18 years or older
- •Undergoing breast cancer surgery with sentinel lymph node evaluation and/or axillary lymph node dissection
- •Provides written informed consent
排除标准
- •Pregnancy
- •Neoadjuvant chemotherapy
- •Prior breast surgery
- •Iodine or seafood allergy
- •Indocyanine green (ICG) allergy
- •Declines or is unable to provide informed consent
结局指标
主要结局
Node-level diagnostic accuracy of AR-ICG fluorescence imaging versus histopathology
时间窗: From surgery to final histopathology (up to ~2 weeks after surgery)
Sensitivity, specificity, positive and negative predictive value, and area under the ROC curve for goggle-based near-infrared fluorescence detection of tumor-positive lymph nodes, using final histopathology as the reference standard, with confidence intervals accounting for clustering of nodes within patients.
次要结局
- Patient-level sentinel-node detection rate(Final histopathology (up to approximately 2 weeks after surgery))
- Concordance of device-marked nodes with histopathology(Final histopathology (up to approximately 2 weeks after surgery))
- Per-device diagnostic performance across near-infrared imaging systems(Through study completion (up to approximately 24 months))
- False-negative rate of AR-ICG fluorescence node detection(Final histopathology (up to approximately 2 weeks after surgery))
- Number of candidate sentinel nodes identified per patient(Intraoperative (day of surgery))
研究者
Borislav Kondov
Professor / Principal Investigator
Ss. Cyril and Methodius University of Skopje