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Application of SERS Technology Based Intraoperative Navigation System in Lung Cancer

Sponsor
Shanghai Pulmonary Hospital, Shanghai, China (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05881057
Collaborator
(none)
200
Enrollment
60
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    200 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Application of Surface-enhanced Raman Scatting (SERS) Technology Based Intraoperative Navigation System in Lung Cancer
    Anticipated Study Start Date :
    Jun 1, 2023
    Anticipated Primary Completion Date :
    Jun 1, 2027
    Anticipated Study Completion Date :
    Jun 1, 2028

    Outcome Measures

    Primary Outcome Measures

    1. 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).

    2. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts 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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Shanghai Pulmonary Hospital, Shanghai, China

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Yayi He, Principal Investigator, Shanghai Pulmonary Hospital, Shanghai, China
    ClinicalTrials.gov Identifier:
    NCT05881057
    Other Study ID Numbers:
    • 2022HY0519
    First Posted:
    May 30, 2023
    Last Update Posted:
    May 30, 2023
    Last Verified:
    May 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Yayi He, Principal Investigator, Shanghai Pulmonary Hospital, Shanghai, China
    surgical margin
    PH
    prognosis
    mass-spectrometry
    Surface-enhanced Raman Scatting (SERS)
    Additional relevant MeSH terms:
    Lung Neoplasms

    Study Results

    No Results Posted as of May 30, 2023