This clinical trial evaluates the use of microdialysis catheters during surgery to collect biomarkers, and studies the feasibility of intra- and post-operative 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 develop new strategies to better diagnose, monitor, and treat brain tumors.
PRIMARY OBJECTIVE: I. Determine biomarkers of in situ gliomas across a diverse patient cohort using intra- or post-operative microdialysis to sample extracellular metabolites and other analytes. 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 are assigned to 1 of 2 cohorts. COHORT I: Patients undergo microdialysis over 15 minutes during standard of care biopsy or resection. Patients also undergo magnetic resonance imaging (MRI) during screening and may undergo MRI on study. COHORT II: Patients undergo microdialysis over 15 minutes after standard of care biopsy or resection. Patients also undergo MRI and computed tomography (CT) on study. After completion of study, patients are followed up for 42 days.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
100
Undergo microdialysis
Undergo MRI
Undergo CT
Mayo Clinic in Rochester
Rochester, Minnesota, United States
RECRUITINGIncidence of adverse events
Will be assessed by evaluating the proportion of patients who: (2) develop persistent adverse events deemed related (possibly, probably, definitely) to the insertion or use of microdialysate catheters. Attribution of neurologic deficit will typically be considered unlikely unless there is evidence of intra-operative intracranial hemorrhage that the surgeon deems to be attributable to use of the microdialysis catheter. Adverse events will be measured by Common Terminology Criteria for Adverse Events 5.0.
Time frame: Up to 42 days
Targeted metabolomics
Metabolites within each region of tumor to brain-adjacent-to tumor within a patient compared. Metabolites from patients without central nervous system malignancies averaged across the epileptic foci group and descriptively compared to the areas from patients with gliomas.
Time frame: Up to 42 days
Microdialysate D-2HG
Concentrations of D-2HG in microdialysate will be descriptively compared between patients with IDH mutated gliomas and those with IDH wildtype gliomas.
Time frame: Up to 42 days
Non-enhancing (FLAIR)- region metabolites
Metabolites of non-glioma, edema-associated FLAIR region of metastatic tumors descriptively compared to those within non-enhancing FLAIR gliomas.
Time frame: Up to 42 days
Necrotic core metabolites
The relative contribution of tumor cellularity versus blood-brain barrier disruption to metabolite production and loss determined by comparing metabolites within the necrotic tumor to those found within the enhancing tumor and brain -adjacent-to-tumor.
Time frame: Up to 42 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.