Feasibility of Intraoperative Microdialysis During Neurosurgery for Central Nervous System Malignancies
NCT ID: NCT04047264
Last Updated: 2025-09-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
100 participants
INTERVENTIONAL
2020-01-01
2027-09-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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Basic Science (microdialysis)
Patients undergo microdialysis over 30 minutes during standard of care biopsy or resection.
Microdialysis
Undergo microdialysis
Magnetic Resonance Imaging
Undergo MRI
Interventions
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Microdialysis
Undergo microdialysis
Magnetic Resonance Imaging
Undergo MRI
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Patients who are not appropriate candidates for surgery due to current or past medical history or uncontrolled concurrent illness
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
National Institute of Neurological Disorders and Stroke (NINDS)
NIH
Mayo Clinic
OTHER
Responsible Party
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Principal Investigators
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Terence C Burns, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic in Rochester
Locations
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Mayo Clinic in Rochester
Rochester, Minnesota, United States
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Related Links
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Mayo Clinic Clinical Trials
Other Identifiers
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NCI-2021-02742
Identifier Type: REGISTRY
Identifier Source: secondary_id
19-004694
Identifier Type: OTHER
Identifier Source: secondary_id
19-004694
Identifier Type: -
Identifier Source: org_study_id
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