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

Glioma Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05901844
• Other study ID #: LRR202301
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2023
• Est. completion date: October 2024

Study information

• Verified date: June 2023
• Source: Beijing Tiantan Hospital
• Contact: Tao Jiang, MD and PhD
• Phone: +86 10 67021832
• Email: taojiang1964[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 256
• Est. completion date: October 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Glioma

Intervention

Diagnostic Test:
• Paraffin pathological diagnosis
Perform two diagnostic methods on the same sample

Locations

Country	Name	City	State
n/a

Sponsors (5)

Lead Sponsor	Collaborator
Beijing Tiantan Hospital	Capital Medical University, Jiangsu Raman Medical Equipment Co., Ltd., The First Affiliated Hospital of Zhengzhou University, West China Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Adverse Event Incidence Rate	Number of subjects with AE/total number of subjects ×100%	During the surgery
Other	Serious Adverse Event Incidence Rate	Number of subjects with SAE/total number of subjects ×100%	During the surgery
Other	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	The Raman analyzer usability evaluation	Use Evaluation Form	Through study completion, an average of 1 year
Secondary	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