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Application of SERS Technology Based Intraoperative Navigation System in Lung Cancer

Application of Surface-enhanced Raman Scatting (SERS) Technology Based Intraoperative Navigation System in Lung Cancer

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05881057
Enrollment
200
Registered
2023-05-30
Start date
2023-06-30
Completion date
2028-06-30
Last updated
2023-05-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Cancer

Keywords

surgical margin, PH, prognosis, mass-spectrometry, Surface-enhanced Raman Scatting (SERS)

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.

Interventions

None listed

Sponsors

Shanghai Pulmonary Hospital, Shanghai, China
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
19 Years to 75 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Overall Survival(OS)From date of randomization until the date of death from any cause, whichever came first, assessed up to 60 monthsTime from randomization to death (from any cause).
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 monthsThe time from surgery to recurrence or the end of follow-up was defined.

Contacts

Primary ContactYayi He, PHD,MD
doctorjael@qq.com+86 021-65115006

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026