Using Raman Analyzer for Diagnosing Gliomas During Surgery
Evaluate the Effectiveness and Safety of the Raman IVD Analyzer in the Molecular Diagnosis of Gliomas During Surgery, Using Samples From Brain Resection Tissue (Ambispective, Multicenter, Blind Evaluation, Single Group Target Value Method)
This study is testing a new tool that uses light to help doctors tell different types of brain tumors apart during surgery to see if it works better than standard methods.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Sex | All |
| Sponsor | Beijing Tiantan Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Beijing, Beijing) |
| Trial ID | NCT06363162 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness and safety of a Raman IVD Analyzer in distinguishing various molecular subtypes of gliomas during surgical procedures. It involves the collection of core tissue samples from patients undergoing brain surgery, which are then analyzed using the Raman analyzer and compared to results from traditional immunohistochemistry and genetic tests. The study aims to establish a clinical intelligence model based on spectral data from 1500 samples, with a focus on accuracy, sensitivity, and specificity of the Raman analyzer in diagnosing gliomas. A total of 200 glioma samples will be prospectively included across multiple trial centers.
Who should consider this trial
Good fit: Ideal candidates are patients scheduled for brain lesion tissue resection surgery with a clinical diagnosis of gliomas who have not undergone prior radiotherapy or chemotherapy.
Not a fit: Patients with prior treatment for gliomas or those with lesions that are not solitary gliomas may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more accurate and timely molecular diagnosis of gliomas during surgery, improving patient outcomes.
How similar studies have performed: Other studies have shown promise in using advanced imaging techniques for intraoperative diagnosis, suggesting potential success for this novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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, consent for immunohistochemistry or genetic test, 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.
Where this trial is running
Beijing, Beijing
- Beijing Tiantan Hospital — Beijing, Beijing, China (Recruiting)
Study contacts
- Principal investigator: Qing Mao — West China Hospital
- Study coordinator: Wang Yinyan, MD and PhD
- Email: tiantanyinyan@126.com
- Phone: +86 13581698953
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.