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)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Glioma
• Intervention / Treatment: Diagnostic test: Paraffin pathological diagnosis

Detailed Description

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).

• Study Type: Interventional
• Enrollment (Estimated): 256
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tao Jiang, MD and PhD; Phone Number: +86 10 67021832; Email: taojiang1964@163.com
• Study Contact Backup: Name: Yinyan Wang, MD and PhD; Phone Number: +86 13581698953; Email: tiantanyinyan@126.com

Participation Criteria

Eligibility Criteria

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

Description

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.

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
Other: Perform two different tests on the same sample; The same sample is diagnosed using a Raman analyzer firstly and then diagnosed by paraffin pathology.	Diagnostic test: Paraffin pathological diagnosis; 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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
The defect occurrence rate of the Raman analyzer	The proportion of subjects with defects in the Raman analyzer during normal use to the total number of subjects using the Raman analyzer	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

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: Tao Jiang, MD and PhD, Beijing Tiantan Hospital; 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 (Estimated): June 1, 2023
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): October 1, 2024

Study Registration Dates

• First Submitted: May 24, 2023
• First Submitted That Met QC Criteria: June 4, 2023
• First Posted (Actual): June 13, 2023

Study Record Updates

• Last Update Posted (Actual): June 13, 2023
• Last Update Submitted That Met QC Criteria: June 4, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: surgery; glioma; intraoperative; Raman
• 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: LRR202301

Drug and device information, study documents

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