Evaluate the Accuracy of Raman IVD Analyzer in the Diagnosis of Gliomas During Surgery
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| 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:
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Outcome Measures
Primary Outcome Measures
- Sensitivity of the Raman analyzer in detecting gliomar [Through study completion, an average of 1 year]
Among the samples determined by paraffin pathology as gliomas, the percentage of samples detected by Raman analyzer as gliomas.
- Specificity of the Raman analyzer in detecting gliomar [Through study completion, an average of 1 year]
Among the samples determined by paraffin pathology as non gliomas, the percentage of samples detected by the Raman analyzer as non gliomas.
Secondary Outcome Measures
- Using the paraffin test results as a reference, calculate the accuracy of the Raman analyzer in detecting gliomar [Through study completion, an average of 1 year]
The proportion of tissue samples with consistent results between Raman analyzer detection and paraffin pathological diagnosis.
- Positive predictive value of the Raman analyzer in detecting gliomar [Through study completion, an average of 1 year]
The percentage of samples diagnosed with glioma by paraffin pathology in the samples detected as glioma by Raman analyzer
- Negative predictive value of Raman analyzer in detecting gliomar [Through study completion, an average of 1 year]
The percentage of samples diagnosed with non glioma by paraffin pathology in the samples detected as non glioma by Raman analyzer
- Kappa coefficient [Through study completion, an average of 1 year]
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.
- The Raman analyzer usability evaluation [Through study completion, an average of 1 year]
Use Evaluation Form
- Time consumption for the Raman analyzer in detecting gliomar [Through study completion, an average of 1 year]
Time required from emitting laser to completing single point detection
Other Outcome Measures
- The defect occurrence rate of the Raman analyzer [Through study completion, an average of 1 year]
The proportion of subjects with defects in the Raman analyzer during normal use to the total number of subjects using the Raman analyzer
- Adverse Event Incidence Rate [During the surgery]
Number of subjects with AE/total number of subjects ×100%
- Serious Adverse Event Incidence Rate [During the surgery]
Number of subjects with SAE/total number of subjects ×100%
- Operator adverse events [Through study completion, an average of 1 year]
Possible damage to device operators during the use and maintenance of the Raman analyzers
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age ≥ 18 years old, regardless of gender;
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Patients who plan to undergo brain lesion tissue resection surgery or have preoperative clinical diagnosis of gliomas and plan to undergo biopsy;
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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;
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The patient or their guardian can understand the research purpose, demonstrate sufficient compliance with the trial protocol, and sign an informed consent form;
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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.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Beijing Tiantan Hospital
- 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 Documents (Full-Text)
None provided.More Information
Publications
None provided.- LRR202301