RecruitingInterventional

Intraoperative Microdialysis During Neurosurgery for Central Nervous System Malignancies

NCT ID: NCT04047264Sponsor: Mayo ClinicLast updated: 2026-02-12

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.

Arms & interventions

ProcedureMicrodialysis
Undergo microdialysis
ProcedureMagnetic Resonance Imaging
Undergo MRI

Outcome measures

Primary

Incidence 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

Secondary

Microdialysate D-2HG
Time frame: Up to 42 days
Non-enhancing (FLAIR)- region metabolites
Time frame: Up to 42 days
Necrotic core metabolites
Time frame: Up to 42 days

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No

Inclusion Criteria: * Age \>= 18 years * Diagnosis of the following, based on clinical and radiographic evidence: * Any glioma * Metastatic brain tumor of any primary origin * Epileptic focus requiring surgical resection * Planned neurosurgical procedure for purposes of biopsy or resection of suspected or previously diagnosed brain tumor (primary or metastatic) or epileptic focus as part of routine clinical care * Willing to undergo neurosurgical resection or biopsy at Mayo Clinic (Rochester, Minnesota \[MN\]) * Ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: * Vulnerable populations: pregnant women, prisoners or the mentally handicapped * Patients who are not appropriate candidates for surgery due to current or past medical history or uncontrolled concurrent illness

Study locations (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905

Recruiting

Clinical Trials Referral Office · Contact

855-776-0015 mayocliniccancerstudies@mayo.edu

Terence C. Burns, MD, PhD · Principal Investigator

References

Riviere-Cazaux C, Rajani K, Rahman M, Oh J, Brown DA, White JF, Himes BT, Jusue-Torres I, Rodriguez M, Warrington AE, Kizilbash SH, Elmquist WF, Burns TC. Methodological and analytical considerations for intra-operative microdialysis. Fluids Barriers CNS. 2023 Dec 19;20(1):94. doi: 10.1186/s12987-023-00497-2.(PubMed)