Application of SERS Technology Based Intraoperative Navigation System in Lung Cancer

N/ANot Yet RecruitingNCT05881057

Shanghai Pulmonary Hospital, Shanghai, China200 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

200

Conditions

Lung Cancer

Eligibility

Sex: ALLMin age: 19 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Overall Survival(OS)

Time from randomization to death (from any cause).

Time frame: From date of randomization until the date of death from any cause, whichever came first, assessed up to 60 months

Recurrence free survival(RFS)

The time from surgery to recurrence or the end of follow-up was defined.

Time frame: From date of randomization until the date of first documented progression from any cause, whichever came first, assessed up to 60 months

Central Contacts

Yayi He, PHD,MD

CONTACT

+86 021-65115006 doctorjael@qq.com

Data from ClinicalTrials.gov

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