GliomaNCT04047264
Feasibility of Intra- and Post-operative Microdialysis During Neurosurgery for Central Nervous System Lesions
A study testing Microdialysis, Magnetic Resonance Imaging and Computed Tomography in people with Glioma and Glioblastoma, run by Mayo Clinic at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioma, Glioblastoma, Metastatic Malignant Neoplasm in the Brain
- What is being tested?
- Microdialysis, Magnetic Resonance Imaging and Computed Tomography
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2020to 1 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
Clinical Trials Referral Office, 855-776-0015, mayocliniccancerstudies@mayo.edu
Terence C. Burns, MD, PhD
About this study
Official title: 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.
Read the detailed description
PRIMARY OBJECTIVE:
- 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:
- 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:
- 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.
- Being tested
- Microdialysis, Magnetic Resonance Imaging, Computed Tomography
- Medical subject headings
- Glioma, Glioblastoma, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MicrodialysisProcedure or surgery
Undergo microdialysis
Magnetic Resonance ImagingProcedure or surgery
Also called Magnetic Resonance Imaging (MRI), Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR
Undergo MRI
Computed TomographyProcedure or surgery
Also called CAT, CAT Scan, Computed Axial Tomography, computerized axial tomography
Undergo CT
| Study group | Role | What they receive |
|---|---|---|
| Cohort I (intra-operative microdialysis) | Experimental | 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. Receives: Procedure: Microdialysis; Procedure: Magnetic Resonance Imaging |
| Cohort II (post-operative microdialysis) | Experimental | Patients undergo microdialysis over 15 minutes after standard of care biopsy or resection. Patients also undergo MRI and CT on study. Receives: Procedure: Microdialysis; Procedure: Magnetic Resonance Imaging; Procedure: Computed Tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events
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.
Measured: Up to 42 days
Targeted metabolomics
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.
Measured: Up to 42 days
Secondary outcomes (3)
Microdialysate D-2HG
Concentrations of D-2HG in microdialysate will be descriptively compared between patients with IDH mutated gliomas and those with IDH wildtype gliomas.
Measured: Up to 42 days
Non-enhancing (FLAIR)- region metabolites
Metabolites of non-glioma, edema-associated FLAIR region of metastatic tumors descriptively compared to those within non-enhancing FLAIR gliomas.
Measured: Up to 42 days
Necrotic core metabolites
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.
Measured: Up to 42 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2019
- Study start1 Jan 2020
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GliomaStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), National Institute of Neurological Disorders and Stroke (NINDS)
- Responsible party
- Sponsor
- Investigators
- Terence C Burns, MD, PhD, Principal investigator, Mayo Clinic in Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04047264
- Sponsor's protocol ID
- 19-004694
- Other IDs
- R37CA276851, R61NS122096, NCI-2021-02742, 19-004694
- Status last verified
- Aug 2026
- First submitted
- 29 Jul 2019
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
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.
PubMed 38115038
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intra- and Post-operative Microdialysis During Neurosurgery for Central Nervous System Lesions
- ClinicalTrials.gov ID
- NCT04047264
- Acronym / sponsor ID
- 19-004694
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 6 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVE:
- 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:
- 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:
- 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 design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort I (intra-operative microdialysis) | Experimental | Procedure: Microdialysis, Procedure: Magnetic Resonance ImagingPatients undergo microdialysis over 15 minutes during standard of care biopsy or resection. Patients also undergo MRI during screening and may undergo MRI on study. |
| Cohort II (post-operative microdialysis) | Experimental | Procedure: Microdialysis, Procedure: Magnetic Resonance Imaging, Procedure: Computed TomographyPatients undergo microdialysis over 15 minutes after standard of care biopsy or resection. Patients also undergo MRI and CT on study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age >= 18 years
- Diagnosis of the following, based on clinical and radiographic evidence:
- 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)
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MicrodialysisUndergo microdialysis | Procedure or surgery | Cohort I (intra-operative microdialysis), Cohort II (post-operative microdialysis) |
| Magnetic Resonance ImagingAlso: Magnetic Resonance Imaging (MRI), Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MRUndergo MRI | Procedure or surgery | Cohort I (intra-operative microdialysis), Cohort II (post-operative microdialysis) |
| Computed TomographyAlso: CAT, CAT Scan, Computed Axial Tomography, computerized axial tomographyUndergo CT | Procedure or surgery | Cohort II (post-operative microdialysis) |
Primary outcome
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.
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.
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2026.
- Derived from this study: PubMed 38115038Riviere-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.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Terence C Burns, MD, PhD principal investigator
Mayo Clinic in Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Microdialysis, Magnetic Resonance Imaging and Computed Tomography in people with Glioma and Glioblastoma, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trials Referral Office (855-776-0015, mayocliniccancerstudies@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events (time frame: Up to 42 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04047264, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2026.