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Clinical Trial Summary

This clinical trial evaluates the use of microdialysis catheters during surgery to collect biomarkers, and studies the feasibility of intraoperative microdialysis during neurosurgery for central nervous system malignancies. A biomarker is a measurable indicator of the severity or presence of disease state. Information collected in this study may help doctors to develop new strategies to better diagnose, monitor, and treat brain tumors.


Clinical Trial Description

PRIMARY OBJECTIVE: I. Determine biomarkers of in situ gliomas across a diverse patient cohort using intra-operative microdialysis to sample extracellular metabolites. SECONDARY OBJECTIVE: I. Evaluate the yield and specificity of microdialysate D-2HG as a candidate tumor biomarker to differentiate between IDH-mutated and IDH-wildtype gliomas. II. Identify biomarkers of tumor-associated processes including brain edema, brain infiltration with non-enhancing tumor, and tumor-associated hypoxia or necrosis. III. Determine the contribution of blood-brain barrier disruption to metabolite abundance within enhancing gliomas. IV. Determine the feasibility of detecting stable-isotope labeled metabolites in human microdialysate. EXPLORATORY/CORRELATIVE OBJECTIVES: I. Perform untargeted metabolomics of tumor microdialysate to elucidate extracellular biomarkers reflective of human central nervous system malignancy subtype, grade, and tumor region. II. Banking of microdialysate specimens for future analyses. OUTLINE: Patients undergo microdialysis over 30 minutes during standard of care biopsy or resection. After completion of study, patients are followed up for 42 days. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04047264
Study type Interventional
Source Mayo Clinic
Contact
Status Recruiting
Phase N/A
Start date January 1, 2020
Completion date September 1, 2027

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