NCT04047264

Feasibility of Intraoperative Microdialysis During Neurosurgery for Central Nervous System Malignancies

Intraoperative Microdialysis During Neurosurgery for Central Nervous System Malignancies

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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. 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.

Conditions

• Glioma
• Glioblastoma
• Metastatic Malignant Neoplasm in the Brain

Interventions

Type	Name	Description
PROCEDURE	Microdialysis	Undergo microdialysis
PROCEDURE	Magnetic Resonance Imaging	Undergo MRI

Timeline

• Start date: 2020-01-01
• Primary completion: 2027-09-01
• Completion: 2027-09-01
• First posted: 2019-08-06
• Last updated: 2026-02-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study