A Multicenter Study in Bronchoscopy Combining Stimulated Raman Histology With Artificial Intelligence for Rapid Lung Cancer Detection
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 900
- 试验地点
- 7
- 主要终点
- Lymph Node Endobronchial Ultrasound Transbronchial Fine Needle Aspiration Endpoint
研究概览
简要总结
The ON-SITE study represents a prospective, observational study focused on the training/tuning and pivotal validation of deep learning algorithms that detect cell/tissue morphology suspicious for cancer in biopsies of peripheral lung nodules/masses and mediastinal/hilar lymph nodes imaged with the NIO Laser Imaging System in the procedure room without requiring traditional sample processing.
The study includes four arms based on biopsy location and biopsy modality/tool:
- Transbronchial forceps biopsy of peripheral lung nodules/masses (peripheral-TBBx)
- Transbronchial needle aspiration biopsy of peripheral lung nodules/masses (peripheral TBNA)
- Transbronchial needle aspiration biopsy of mediastinal/hilar lymph nodes (EBUS-TBNA)
- Transbronchial cryo biopsy of peripheral lung nodules/masses (peripheral-CBx)
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient or legal guardian is willing and able to understand, sign and date the Ethics committee approved study specific Informed Consent Form.
- •The patient is 22 years of age or older.
- •The patient is scheduled for routinely indicated staging of the mediastinum (EBUS-TBNA) and planned peripheral lung biopsy procedure (peripheral TBBx/TBNA) with an intermediate to high pretest probability of lung cancer based on clinician suspicion.
- •The patient can tolerate the clinical procedure as indicated.
排除标准
- •Patient is a prisoner.
- •The participant, in the judgment of the Investigator, may be inappropriate for the intended study procedures
结局指标
主要结局
Lymph Node Endobronchial Ultrasound Transbronchial Fine Needle Aspiration Endpoint
时间窗: From enrollment to the End of the Procedure.
Determine area-under-the-curve (AUC) of the receiver-operating-characteristic (ROC) of NIO image analysis module for detection of cancer at a lymph-node location.
Peripheral Lung Transbronchial Fine Needle Aspiration Endpoint
时间窗: From enrollment to the End of the Procedure.
Detection of lung cancer in peripheral lung transbronchial needle aspiration by NIO image analysis module with non-inferior performance compared to rapid on-site evaluation (ROSE).
Peripheral TBBx and CBx Co-primary Endpoints
时间窗: From enrollment to the End of the Procedure.
Detection of lung cancer in peripheral TBBx and CBx biopsies by NIO image analysis module with non-inferior performance compared to rapid on-site evaluation touch imprint cytology (ROSE-TIC)
次要结局
未报告次要终点