Feasibility of Intra- and Post-operative Microdialysis During Neurosurgery for Central Nervous System Lesions
August 14, 2026 updated by: Mayo Clinic
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.
Study Overview
Status
Recruiting
Intervention / Treatment
Detailed Description
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.
Study Type
Interventional
Enrollment (Estimated)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Clinical Trials Referral Office
- Phone Number: 855-776-0015
- Email: mayocliniccancerstudies@mayo.edu
Study Locations
-
-
Minnesota
-
Rochester, Minnesota, United States, 55905
- Recruiting
- Mayo Clinic in Rochester
-
Contact:
- Clinical Trials Referral Office
- Phone Number: 855-776-0015
- Email: mayocliniccancerstudies@mayo.edu
-
Principal Investigator:
- Terence C. Burns, MD, PhD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Cohort I (intra-operative microdialysis)
Patients undergo microdialysis over 15 minutes during standard of care biopsy or resection.
Patients also undergo MRI during screening and may undergo MRI on study.
|
Undergo MRI
Other Names:
Undergo microdialysis
|
|
Experimental: Cohort II (post-operative microdialysis)
Patients undergo microdialysis over 15 minutes after standard of care biopsy or resection.
Patients also undergo MRI and CT on study.
|
Undergo MRI
Other Names:
Undergo CT
Other Names:
Undergo microdialysis
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Up to 42 days
|
|
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.
|
Up to 42 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Up to 42 days
|
|
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.
|
Up to 42 days
|
|
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.
|
Up to 42 days
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Microdialysate oncometabolites
Time Frame: Up to 42 days
|
Will be assessed by untargeted metabolomic analyses will be tabulated and evaluated for hypothesis generation.
|
Up to 42 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Terence C Burns, MD, PhD, Mayo Clinic in Rochester
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2020
Primary Completion (Estimated)
September 1, 2027
Study Completion (Estimated)
September 1, 2027
Study Registration Dates
First Submitted
July 29, 2019
First Submitted That Met QC Criteria
August 5, 2019
First Posted (Actual)
August 6, 2019
Study Record Updates
Last Update Posted (Actual)
August 18, 2026
Last Update Submitted That Met QC Criteria
August 14, 2026
Last Verified
August 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neoplasms by Site
- Neoplasms
- Neoplasms by Histologic Type
- Neoplasms, Glandular and Epithelial
- Astrocytoma
- Neoplasms, Neuroepithelial
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Nervous System Neoplasms
- Central Nervous System Neoplasms
- Glioblastoma
- Glioma
- Brain Neoplasms
- Investigative Techniques
- Chemistry Techniques, Analytical
- Spectrum Analysis
- Dialysis
- Magnetic Resonance Spectroscopy
- Microdialysis
Other Study ID Numbers
- 19-004694 (Other Identifier: Mayo Clinic Institutional Review Board)
- NCI-2021-02742 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
- R61NS122096 (U.S. NIH Grant/Contract)
- R37CA276851 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.