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NCT Number: NCT05881057

Application of SERS Technology Based Intraoperative Navigation System in Lung Cancer

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. Overall Survival(OS)

    Time frame: 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)

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Yayi He, PHD,MD

CONTACT

[email protected]

+86 021-65115006

Sponsors and collaborators

Lead sponsor

Shanghai Pulmonary Hospital, Shanghai, China

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2027
Study completion
2028
First posted
May 30, 2023
Registry last updated
May 30, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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