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

Primary Purpose

Glioma

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Paraffin pathological diagnosis
Sponsored by
Beijing Tiantan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Glioma focused on measuring glioma, Raman, intraoperative, surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    Perform two different tests on the same sample

    Arm Description

    The same sample is diagnosed using a Raman analyzer firstly and then diagnosed by paraffin pathology.

    Outcomes

    Primary Outcome Measures

    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.
    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.

    Secondary Outcome Measures

    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.
    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
    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
    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.
    The Raman analyzer usability evaluation
    Use Evaluation Form
    Time consumption for the Raman analyzer in detecting gliomar
    Time required from emitting laser to completing single point detection

    Full Information

    First Posted
    May 24, 2023
    Last Updated
    June 4, 2023
    Sponsor
    Beijing Tiantan Hospital
    Collaborators
    West China Hospital, The First Affiliated Hospital of Zhengzhou University, Capital Medical University, Jiangsu Raman Medical Equipment Co., Ltd.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05901844
    Brief Title
    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

    2. Study Status

    Record Verification Date
    June 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    June 2023 (Anticipated)
    Primary Completion Date
    June 2024 (Anticipated)
    Study Completion Date
    October 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Beijing Tiantan Hospital
    Collaborators
    West China Hospital, The First Affiliated Hospital of Zhengzhou University, Capital Medical University, Jiangsu Raman Medical Equipment Co., Ltd.

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. 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.
    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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Glioma
    Keywords
    glioma, Raman, intraoperative, surgery

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    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.
    Masking
    None (Open Label)
    Masking Description
    Blind assessment: Researchers using Raman analyzer during surgery are not aware of the subjects' preoperative diagnostic results, while researchers conducting paraffin pathology examinations after surgery are not aware of the subjects' preoperative diagnostic results and the diagnostic results of Raman analyzer.
    Allocation
    N/A
    Enrollment
    256 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Perform two different tests on the same sample
    Arm Type
    Other
    Arm Description
    The same sample is diagnosed using a Raman analyzer firstly and then diagnosed by paraffin pathology.
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    Paraffin pathological diagnosis
    Other Intervention Name(s)
    Raman analyzer diagnosis
    Intervention Description
    Perform two diagnostic methods on the same sample
    Primary Outcome Measure Information:
    Title
    Sensitivity of the Raman analyzer in detecting gliomar
    Description
    Among the samples determined by paraffin pathology as gliomas, the percentage of samples detected by Raman analyzer as gliomas.
    Time Frame
    Through study completion, an average of 1 year
    Title
    Specificity of the Raman analyzer in detecting gliomar
    Description
    Among the samples determined by paraffin pathology as non gliomas, the percentage of samples detected by the Raman analyzer as non gliomas.
    Time Frame
    Through study completion, an average of 1 year
    Secondary Outcome Measure Information:
    Title
    Using the paraffin test results as a reference, calculate the accuracy of the Raman analyzer in detecting gliomar
    Description
    The proportion of tissue samples with consistent results between Raman analyzer detection and paraffin pathological diagnosis.
    Time Frame
    Through study completion, an average of 1 year
    Title
    Positive predictive value of the Raman analyzer in detecting gliomar
    Description
    The percentage of samples diagnosed with glioma by paraffin pathology in the samples detected as glioma by Raman analyzer
    Time Frame
    Through study completion, an average of 1 year
    Title
    Negative predictive value of Raman analyzer in detecting gliomar
    Description
    The percentage of samples diagnosed with non glioma by paraffin pathology in the samples detected as non glioma by Raman analyzer
    Time Frame
    Through study completion, an average of 1 year
    Title
    Kappa coefficient
    Description
    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.
    Time Frame
    Through study completion, an average of 1 year
    Title
    The Raman analyzer usability evaluation
    Description
    Use Evaluation Form
    Time Frame
    Through study completion, an average of 1 year
    Title
    Time consumption for the Raman analyzer in detecting gliomar
    Description
    Time required from emitting laser to completing single point detection
    Time Frame
    Through study completion, an average of 1 year
    Other Pre-specified Outcome Measures:
    Title
    The defect occurrence rate of the Raman analyzer
    Description
    The proportion of subjects with defects in the Raman analyzer during normal use to the total number of subjects using the Raman analyzer
    Time Frame
    Through study completion, an average of 1 year
    Title
    Adverse Event Incidence Rate
    Description
    Number of subjects with AE/total number of subjects ×100%
    Time Frame
    During the surgery
    Title
    Serious Adverse Event Incidence Rate
    Description
    Number of subjects with SAE/total number of subjects ×100%
    Time Frame
    During the surgery
    Title
    Operator adverse events
    Description
    Possible damage to device operators during the use and maintenance of the Raman analyzers
    Time Frame
    Through study completion, an average of 1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Tao Jiang, MD and PhD
    Phone
    +86 10 67021832
    Email
    taojiang1964@163.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Yinyan Wang, MD and PhD
    Phone
    +86 13581698953
    Email
    tiantanyinyan@126.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Tao Jiang, MD and PhD
    Organizational Affiliation
    Beijing Tiantan Hospital
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Qing Mao
    Organizational Affiliation
    West China Hospital
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Dongming Yan
    Organizational Affiliation
    The First Affiliated Hospital of Zhengzhou University
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Shouwei Li
    Organizational Affiliation
    Capital Medical University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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

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