Neoplasms

All Conditions

Rare Diseases

Glioma

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Neuroepithelioma

The same sample is diagnosed using a Raman analyzer firstly and then diagnosed by paraffin pathology.

Perform two diagnostic methods on the same sample

Paraffin pathological diagnosis

Tao Jiang, MD and PhD

Yinyan Wang, MD and PhD

Qing Mao

Dongming Yan

Shouwei Li

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.

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).

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.

Blind assessment: Researchers using Raman analyzer during surgery are not aware of the subjects' preoperative diagnostic results, while researchers conducting paraffin pathology examinations after surgery are not aware of the subjects' preoperative diagnostic results and the diagnostic results of Raman analyzer.

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

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)

The proportion of subjects with defects in the Raman analyzer during normal use to the total number of subjects using the Raman analyzer

Number of subjects with AE/total number of subjects ×100%

Number of subjects with SAE/total number of subjects ×100%

Possible damage to device operators during the use and maintenance of the Raman analyzers

Among the samples determined by paraffin pathology as gliomas, the percentage of samples detected by Raman analyzer as gliomas.

Among the samples determined by paraffin pathology as non gliomas, the percentage of samples detected by the Raman analyzer as non gliomas.

The proportion of tissue samples with consistent results between Raman analyzer detection and paraffin pathological diagnosis.

The percentage of samples diagnosed with glioma by paraffin pathology in the samples detected as glioma by Raman analyzer

The percentage of samples diagnosed with non glioma by paraffin pathology in the samples detected as non glioma by Raman analyzer

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Evaluate the Accuracy of Raman IVD Analyzer in the Diagnosis of Gliomas During Surgery	NCT05901844	Glioma	Paraffin pathol...	18 Years -	Beijing Tiantan Hospital
Evaluate the Accuracy of Raman IVD Analyzer in the Diagnosis of Gliomas During Surgery	NCT05901844	Glioma	Paraffin pathol...	18 Years -	Beijing Tiantan Hospital

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