Evaluate the Effectiveness and Safety of Raman IVD Analyzer in the Molecular Diagnosis of Gliomas During Surgery

Evaluate the Effectiveness and Safety of the Raman IVD Analyzer in the Molecular Diagnosis of Gliomas During Surgery, Using Samples From Brain Resection Tissue (Ambispective, Multicenter, Blind Evaluation, Single Group Target Value Method)

To distinguish various molecular subtypes of gliomas by spectra data obtained from Raman analyzer, including IDH mutant, 1p/19q-codeleted, ATRX deletion, TERT promoter mutation, MGMT promoter methylation, EGFR amplification, H3 K27-altered, TP53 mutant, PTEN deficiency, ki 67, AQP4, VEGF, and so on, comparing with the results of Immunohistochemistry or genetic test on the same brain tissue samples.

Study Overview

• Status: Recruiting
• Conditions: Glioma
• Intervention / Treatment: Diagnostic test: Immunohistochemistry or genetic test

Detailed Description

1500 samples were included retrospectively with the spectra data obtained from Raman analyzer to establish clinical intelligence model, modifying the analyzer. Based on statistical calculations, 200 glioma samples will be included in the trial in all trial centers prospectively. Compare the results between the Raman analyzer and Immunohistochemistry or genetic test results. And calculate the AUC, the accuracy, sensitivity, the specificity, and other indicators of Raman analyzer.

During surgery, core 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 Immunohistochemistry or genetic test.

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).

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Wang Yinyan, MD and PhD; Phone Number: +86 13581698953; Email: tiantanyinyan@126.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100071
      • Recruiting
      • Beijing Tiantan Hospital
      • Contact: Yinyan Wang, MD and PhD; Phone Number: +86 13581698953; Email: tiantanyinyan@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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, consent for immunohistochemistry or genetic test, 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Perform two different tests on the same sample; Perform the diagnosis of Raman analyzer and immunohistochemistry or genetic test on the same sample.	Diagnostic test: Immunohistochemistry or genetic test; Perform two diagnostic methods on the same sample; Other Names: Raman analyzer diagnosis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area Under the Curve	The Area Under the Curve of the ROC curve illustrates the performance of Raman analyzer for the diagnosis of molecular subtype in glioma, confirmed by immunohistochemistry or genetic test.	Through study completion, an average of 1 year
Accuracy	The proportion of tissue samples with consistent results between Raman analyzer detection and immunohistochemistry or genetic test.	Through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Adverse Event Incidence Rate	Number of subjects with AE/total number of subjects ×100%	During the surgery
Serious Adverse Event Incidence Rate	Number of subjects with SAE/total number of subjects ×100%	During the surgery
Operator adverse events	Possible damage to device operators during the use and maintenance of the Raman analyzers	Through study completion, an average of 1 year
Sensitivity	Among one kind of molecular subtype samples determined by immunohistochemistry or genetic test, the percentage of samples detected by Raman analyzer as the same molecular subtype.	Through study completion, an average of 1 year
Specificity	Among one kind of molecular subtype samples determined by immunohistochemistry or genetic test, the percentage of samples detected by Raman analyzer as the different molecular subtype.	Through study completion, an average of 1 year
Time consumption for the Raman analyzer in detection	Time required from emitting laser to completing single point detection	Through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Beijing Tiantan Hospital
• Collaborators: West China Hospital; The First Affiliated Hospital of Zhengzhou University; Capital Medical University; Jiangsu Raman Medical Equipment Co., Ltd.
• Investigators: Principal Investigator: Qing Mao, West China hospital; Principal Investigator: Dongming Yan, The First Affiliated Hospital of Zhengzhou University; Principal Investigator: Shouwei Li, Capital Medical University

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2022
• Primary Completion (Estimated): June 30, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: April 9, 2024
• First Submitted That Met QC Criteria: April 9, 2024
• First Posted (Actual): April 12, 2024

Study Record Updates

• Last Update Posted (Actual): April 12, 2024
• Last Update Submitted That Met QC Criteria: April 9, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: surgery; intraoperative; Raman; Molecular subtype
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Glioma
• Other Study ID Numbers: LRR202404

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No