Feasibility of Intra- and Post-operative Microdialysis During Neurosurgery for Central Nervous System Lesions

Intra- and Post-operative Microdialysis During Neurosurgery for Central Nervous System Lesions

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.

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)]

• For patients with gliomas recruited for post-operative microdialysis, willingness to stay in the hospital through post-operative day (POD) 3-5 (timing per physician and patient's shared decision making)

• Ability to understand and the willingness to sign a written informed consent document

• Enrollment into the Biobank study (IRB#12-003458)

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