Evaluate the Accuracy of Raman IVD Analyzer in the Diagnosis of Gliomas During Surgery

Study Overview
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Brief Summary
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Compare the data obtained from the Raman analyzer and paraffin pathology examination on the same external brain tissue sample. Evaluate the effectiveness and safety of the Raman analyzer for intraoperative diagnosis gliomas of brain resection tissue samples, using paraffin pathological examination results as clinical reference standards.

Detailed Description
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Based on statistical calculations,108 positive samples and 148 negative samples will be included in the trial in all trial centers. Compare the results between the Raman analyzer and the paraffin pathological. And calculate the sensitivity, the specificity, and other indicators of Raman analyzer. During surgery, core or marginal tissue samples were taken from subjects. The test samples size:0.2cm<length diameter ≤ 2cm. The sample testing result is based on the Raman test points. Then take the same tissue sample for paraffin pathological diagnosis. Statistical description of all data, including baseline data, all efficacy indicators, and all safety data. The measurement data give the mean, standard deviation, minimum, maximum, median,25 quantile and 75 quantile; Provide frequency and composition ratio for counting data. The baseline data was analyzed using the Full Analysis Set (FAS); The effectiveness analysis adopts FAS and PPS; The security analysis uses the Security Dataset (SS).

Official Title
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Evaluate the Effectiveness and Safety of the Raman IVD Analyzer for Intraoperative Glioma Diagnosis, Using Samples From Brain Resection Tissue (Prospective, Multicenter, Blind Evaluation, Single Group Target Value Method)

Conditions
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Glioma

Intervention / Treatment
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* Diagnostic Test: Paraffin pathological diagnosis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years old, regardless of gender; Patients who plan to undergo brain lesion tissue resection surgery or have preoperative clinical diagnosis of gliomas and plan to undergo biopsy; Patients with clinical diagnosis of initial solitary gliomas, or initial solitary intracranial masses or initial non occupying lesions that do not exclude gliomas (such as intracranial metastatic lesions, intracranial infectious lesions, intracranial demyelinating lesions, central nervous system lymphoma, etc.), who have not received radiotherapy or chemotherapy in the past based on their medical history; The patient or their guardian can understand the research purpose, demonstrate sufficient compliance with the trial protocol, and sign an informed consent form; It is possible to obtain tissue samples with a length diameter greater than 0.2cm. Patients diagnosed with initial solitary glioma should take core or marginal tissue, while patients diagnosed with initial single intracranial mass or initial non mass lesions but maybe with gliomas should be taken core tissue. Exclusion Criteria: Investigator judge that it is not suitable for inclusion.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: The same sample was diagnosed using Raman spectroscopy and paraffin pathology, respectively. Calculate the sensitivity and specificity of a Raman analyzer using paraffin pathological results as the gold standard.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Perform two different tests on the same sample<br>The same sample is diagnosed using a Raman analyzer firstly and then diagnosed by paraffin pathology. | Diagnostic Test: Paraffin pathological diagnosis<br>* Perform two diagnostic methods on the same sample<br>* Other names: Raman analyzer diagnosis;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity of the Raman analyzer in detecting gliomar | Among the samples determined by paraffin pathology as gliomas, the percentage of samples detected by Raman analyzer as gliomas. | Through study completion, an average of 1 year | 
| Specificity of the Raman analyzer in detecting gliomar | Among the samples determined by paraffin pathology as non gliomas, the percentage of samples detected by the Raman analyzer as non gliomas. | Through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Using the paraffin test results as a reference, calculate the accuracy of the Raman analyzer in detecting gliomar | The proportion of tissue samples with consistent results between Raman analyzer detection and paraffin pathological diagnosis. | Through study completion, an average of 1 year | 
| Positive predictive value of the Raman analyzer in detecting gliomar | The percentage of samples diagnosed with glioma by paraffin pathology in the samples detected as glioma by Raman analyzer | Through study completion, an average of 1 year | 
| Negative predictive value of Raman analyzer in detecting gliomar | The percentage of samples diagnosed with non glioma by paraffin pathology in the samples detected as non glioma by Raman analyzer | Through study completion, an average of 1 year | 
| Kappa coefficient | Kappa coefficient≥0.75 indicates high consistency; 0.75>Kappa coefficient≥0.4, considered consistent; If the Kappa coefficient is less than 0.4, it is considered inconsistent. | Through study completion, an average of 1 year | 
| The Raman analyzer usability evaluation | Use Evaluation Form | Through study completion, an average of 1 year | 
| Time consumption for the Raman analyzer in detecting gliomar | Time required from emitting laser to completing single point detection | Through study completion, an average of 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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glioma, Raman, intraoperative, surgery