Application of SERS Technology Based Intraoperative Navigation System in Lung Cancer

Not yet recruiting

• Conditions: Lung Cancer

• Registration Number: NCT05881057
• Lead Sponsor: Shanghai Pulmonary Hospital, Shanghai, China

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Status Verified: 2023-05
• Study First Submitted: 2023-05-19
• Study First Submitted QC: 2023-05-27
• Last Update Submitted: 2023-05-27
• Study First Posted: 2023-05-30
• Last Update Posted: 2023-05-30
• Study Start: 2023-06
• Primary Completion: 2027-06
• Study Completion: 2028-06

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

1. 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.
2. Male or female aged 18-75 years or more when signing ICF.
3. Extended tumor resection was performed to remove the lung tumor tissue, and the resection margin was ≥2cm from the tumor margin.
4. The effective measured diameter of all the lung tissues to be measured was greater than 0.5cm.
5. The patient had not received previous systemic therapy for cancer.

Exclusion Criteria

1. Unresectable lung cancer patients.
2. Patients had received previous systemic therapy for lung cancer.
3. Patients with other active malignant tumors within the past year or at the same time.
4. The patient had a known history of psychotropic drug abuse or drug use; She had a history of alcohol abuse.
5. According to the investigator's judgment, the patient had other factors that may lead to the early termination of the study.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Recurrence free survival(RFS)	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)	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).