Feasibility of Intraoperative Microdialysis During Neurosurgery for Central Nervous System Malignancies

Official title

Intraoperative Microdialysis During Neurosurgery for Central Nervous System Malignancies

Overview

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.

Interventions

• Procedure Microdialysis
  Undergo microdialysis
• Procedure Magnetic Resonance Imaging
  Undergo MRI

Primary outcome measures

• Incidence of adverse events [Time frame: Up to 42 days]
• Targeted metabolomics [Time frame: Up to 42 days]

Secondary outcome measures (3)

• 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

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Basic science

Study locations

United States · 1 center

• Mayo Clinic in Rochester — Rochester

Publications

• 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. PMID 38115038

Identifiers

NCT: NCT04047264 · 19-004694 · NCI-2021-02742 · 19-004694 · R37CA276851 · R61NS122096

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗