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Trial Title:
Evaluate the Accuracy of Raman IVD Analyzer in the Diagnosis of Gliomas During Surgery
NCT ID:
NCT05901844
Condition:
Glioma
Conditions: Official terms:
Glioma
Conditions: Keywords:
glioma
Raman
intraoperative
surgery
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
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
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.
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
Paraffin pathological diagnosis
Description:
Perform two diagnostic methods on the same sample
Arm group label:
Perform two different tests on the same sample
Other name:
Raman analyzer diagnosis
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
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
June 2023
Completion date:
October 2024
Lead sponsor:
Agency:
Beijing Tiantan Hospital
Agency class:
Other
Collaborator:
Agency:
West China Hospital
Agency class:
Other
Collaborator:
Agency:
The First Affiliated Hospital of Zhengzhou University
Agency class:
Other
Collaborator:
Agency:
Capital Medical University
Agency class:
Other
Collaborator:
Agency:
Jiangsu Raman Medical Equipment Co., Ltd.
Agency class:
Industry
Source:
Beijing Tiantan Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05901844
