Application of Surface-enhanced Raman Scatting (SERS) Technology Based Intraoperative Navigation System in Lung Cancer
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 主要终点
- Recurrence free survival(RFS)
研究概览
简要总结
This study aims to explore the application of Surface-enhanced Raman Scatting (SERS) technology in lung cancer surgery and clarify its mechanism through multi-omics mass spectrometry platform, and then further prove the clinical transformation value of this technology.
详细描述
This study intends to apply the intraoperative navigation system based on Surface-enhanced Raman Scatting (SERS) technology to detect the PH of lung tissue, and to evaluate the benign and malignant resection margins of lung tissue based on this. In order to clarify the discrimination mechanism, a multi-omics mass spectrometry platform is planned to study the internal small molecules and pathway changes. In addition, the patients were followed up for five years to explore the correlation between the prognosis of patients and the PH of lung tissues and lymph nodes, which could prove the clinical transformation value of this technology.
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
- 19 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Voluntary participation in clinical research; Fully understand and informed the study and sign the informed consent form (ICF); Be willing to follow and be able to complete all trial procedures.
- •Male or female aged 18-75 years or more when signing ICF.
- •Extended tumor resection was performed to remove the lung tumor tissue, and the resection margin was ≥2cm from the tumor margin.
- •The effective measured diameter of all the lung tissues to be measured was greater than 0.5cm.
- •The patient had not received previous systemic therapy for cancer.
排除标准
- •Unresectable lung cancer patients.
- •Patients had received previous systemic therapy for lung cancer.
- •Patients with other active malignant tumors within the past year or at the same time.
- •The patient had a known history of psychotropic drug abuse or drug use; She had a history of alcohol abuse.
- •According to the investigator's judgment, the patient had other factors that may lead to the early termination of the study.
结局指标
主要结局
Recurrence free survival(RFS)
时间窗: From date of randomization until the date of first documented progression from any cause, whichever came first, assessed up to 60 months
The time from surgery to recurrence or the end of follow-up was defined.
Overall Survival(OS)
时间窗: From date of randomization until the date of death from any cause, whichever came first, assessed up to 60 months
Time from randomization to death (from any cause).
次要结局
未报告次要终点
研究者
Yayi He
Principal Investigator
Shanghai Pulmonary Hospital, Shanghai, China