Clinical trial NCT05901844: Evaluate the Accuracy of Raman IVD Analyzer in the Diagnosis of Gliomas During Surgery
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)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Glioma
Keywords: glioma
Raman
intraoperative
surgery
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
Collaborators: name: West China Hospital
name: The First Affiliated Hospital of Zhengzhou University
name: Capital Medical University
name: Jiangsu Raman Medical Equipment Co., Ltd.
First posted: 2023-06-13
Enrollment: 256
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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.
Primary purpose: DIAGNOSTIC

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.

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Sensitivity of the Raman analyzer in detecting gliomar
timeFrame: Through study completion, an average of 1 year
measure: Specificity of the Raman analyzer in detecting gliomar
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: Using the paraffin test results as a reference, calculate the accuracy of the Raman analyzer in detecting gliomar
timeFrame: Through study completion, an average of 1 year
measure: Positive predictive value of the Raman analyzer in detecting gliomar
timeFrame: Through study completion, an average of 1 year
measure: Negative predictive value of Raman analyzer in detecting gliomar
timeFrame: Through study completion, an average of 1 year
measure: Kappa coefficient
timeFrame: Through study completion, an average of 1 year
measure: The Raman analyzer usability evaluation
timeFrame: Through study completion, an average of 1 year
measure: Time consumption for the Raman analyzer in detecting gliomar
timeFrame: Through study completion, an average of 1 year
Other outcomes:
measure: The defect occurrence rate of the Raman analyzer
timeFrame: Through study completion, an average of 1 year
measure: Adverse Event Incidence Rate
timeFrame: During the surgery
measure: Serious Adverse Event Incidence Rate
timeFrame: During the surgery
measure: Operator adverse events
timeFrame: Through study completion, an average of 1 year
Locations:
Study officials:
affiliation: Beijing Tiantan Hospital
name: Tao Jiang, MD and PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: West China Hospital
name: Qing Mao
role: PRINCIPAL_INVESTIGATOR
affiliation: The First Affiliated Hospital of Zhengzhou University
name: Dongming Yan
role: PRINCIPAL_INVESTIGATOR
affiliation: Capital Medical University
name: Shouwei Li
role: PRINCIPAL_INVESTIGATOR
References: