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Trial Title:
Application of SERS Technology Based Intraoperative Navigation System in Lung Cancer
NCT ID:
NCT05881057
Condition:
Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Conditions: Keywords:
surgical margin
PH
prognosis
mass-spectrometry
Surface-enhanced Raman Scatting (SERS)
Study type:
Observational
Overall status:
Not yet recruiting
Study design:
Time perspective:
Prospective
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.
Criteria for eligibility:
Study pop:
Non-small cell lung cancer surgery patients in Shanghai Pulmonary Hospital
Sampling method:
Non-Probability Sample
Criteria:
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.
Gender:
All
Minimum age:
19 Years
Maximum age:
75 Years
Healthy volunteers:
No
Start date:
June 2023
Completion date:
June 2028
Lead sponsor:
Agency:
Shanghai Pulmonary Hospital, Shanghai, China
Agency class:
Other
Source:
Shanghai Pulmonary Hospital, Shanghai, China
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05881057
