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SERS-Based Diagnosis of Leptomeningeal Metastasis in EGFR-Mutant NSCLC
Sponsor: limeifang
Summary
This prospective, multicenter study aims to address the low sensitivity of cerebrospinal fluid (CSF) cytology (60-70%) in diagnosing leptomeningeal metastasis (LM) in patients with EGFR-mutant lung cancer. We will establish a diagnostic methodology and develop a predictive model using surface-enhanced Raman spectroscopy (SERS) technology to improve diagnostic accuracy and guide subsequent clinical management.
Official title: Development and Validation of a SERS-based Diagnostic Approach for Leptomeningeal Metastasis in EGFR-mutant Advanced NSCLC: a Prospective Multicenter Study
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
74
Start Date
2026-01-24
Completion Date
2027-06-30
Last Updated
2026-11-03
Healthy Volunteers
No
Interventions
Surface-Enhanced Raman Spectroscopy (SERS) Detection
In this study, cerebrospinal fluid (CSF) samples are analyzed using surface-enhanced Raman spectroscopy (SERS). SERS is a highly sensitive spectroscopic technique based on nanostructured metallic substrates, capable of capturing characteristic "molecular fingerprint" signals from trace amounts of metabolites, proteins, nucleic acids, and other biomolecules released by tumor cells into the CSF.Detection procedure: CSF specimens are collected from participants via lumbar puncture. After centrifugation, the supernatant is deposited onto a SERS-active substrate, and Raman scattering spectra are acquired under laser excitation. The acquired spectral data undergo preprocessing steps including baseline correction, smoothing, and noise reduction, followed by extraction of characteristic peak information.
Locations (1)
the 900th Hospital of the Joint Logistics Support Force; Fujian Cancer Hospital; Fujian Provincial People's Hospital
Fuzhou, Fujian, China