Feasibility of Intraoperative Microdialysis During Neurosurgery for Central Nervous System Malignancies

Mayo Clinic

Status

Enrolling

Conditions

Glioblastoma

Glioma

Metastatic Malignant Neoplasm in the Brain

Treatments

Procedure: Microdialysis

Procedure: Magnetic Resonance Imaging

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT04047264

R61NS122096 (U.S. NIH Grant/Contract)

R37CA276851 (U.S. NIH Grant/Contract)

NCI-2021-02742 (Registry Identifier)

19-004694

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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