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

NCT05901844 | Unknown

• 1 other identifier: LRR202301
• Study Type: interventional
• Target: 256
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Glioma

Keywords

glioma; Raman; intraoperative; surgery

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• 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

• Positive predictive value of the Raman analyzer in detecting gliomar

  Through study completion, an average of 1 year

• Negative predictive value of Raman analyzer in detecting gliomar

  Through study completion, an average of 1 year

• Kappa coefficient

  Through study completion, an average of 1 year

• The Raman analyzer usability evaluation

  Through study completion, an average of 1 year

Other Outcomes (4)

• The defect occurrence rate of the Raman analyzer

  Through study completion, an average of 1 year

• Adverse Event Incidence Rate

  During the surgery

• Serious Adverse Event Incidence Rate

  During the surgery

Study Arms (1)

Perform two different tests on the same sample

OTHER

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

Diagnostic Test: Paraffin pathological diagnosis

Interventions

Paraffin pathological diagnosis DIAGNOSTIC_TEST

Perform two diagnostic methods on the same sample

Also known as: Raman analyzer diagnosis

Perform two different tests on the same sample

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead
• West China Hospital: collaborator
• The First Affiliated Hospital of Zhengzhou University: collaborator
• Capital Medical University: collaborator
• Jiangsu Raman Medical Equipment Co., Ltd.: collaborator

MeSH Terms

Conditions

Glioma

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tao Jiang, MD and PhD

CONTACT

+86 10 67021832; taojiang1964@163.com

Yinyan Wang, MD and PhD

CONTACT

+86 13581698953; tiantanyinyan@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: 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.
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 24, 2023
• First Posted: June 13, 2023
• Study Start: June 1, 2023
• Primary Completion: June 1, 2024
• Study Completion: October 1, 2024
• Last Updated: June 13, 2023

Record last verified: 2023-06