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NCT Number: NCT04047264

Feasibility of Intraoperative Microdialysis During Neurosurgery for Central Nervous System Malignancies

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location status: Recruiting

Location contact

Clinical Trials Referral Office

CONTACT

[email protected]

855-776-0015

Terence C. Burns, MD, PhD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Microdialysis

Procedure

Undergo microdialysis

Magnetic Resonance Imaging

Procedure

Undergo MRI

Other names: Magnetic Resonance Imaging (MRI), Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR, MR Imaging, NMR Imaging, Nuclear Magnetic Resonance Imaging (NMRI), nuclear magnetic resonance imaging, sMRI, Structural MRI

Primary outcomes

  1. Incidence of adverse events

    Time frame: Up to 42 days

    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.

  2. Targeted metabolomics

    Time frame: Up to 42 days

    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.

Secondary outcomes

  1. Microdialysate D-2HG

    Time frame: Up to 42 days

    Concentrations of D-2HG in microdialysate will be descriptively compared between patients with IDH mutated gliomas and those with IDH wildtype gliomas.

  2. Non-enhancing (FLAIR)- region metabolites

    Time frame: Up to 42 days

    Metabolites of non-glioma, edema-associated FLAIR region of metastatic tumors descriptively compared to those within non-enhancing FLAIR gliomas.

  3. Necrotic core metabolites

    Time frame: Up to 42 days

    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.

Other outcomes

  1. Microdialysate oncometabolites

    Time frame: Up to 42 days

    Will be assessed by untargeted metabolomic analyses will be tabulated and evaluated for hypothesis generation.

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical Trials Referral Office

CONTACT

[email protected]

855-776-0015

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • National Cancer Institute (NCI)
  • National Institute of Neurological Disorders and Stroke (NINDS)

Registry information

Official study title

Intraoperative Microdialysis During Neurosurgery for Central Nervous System Malignancies

Important dates

Study start
2020
Primary completion
2027
Study completion
2027
First posted
Aug 6, 2019
Registry last updated
Feb 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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