Feasibility of Intra- and Post-operative Microdialysis During Neurosurgery for Central Nervous System Lesions
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMayo Clinic
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age >= 18 years
Any glioma
Metastatic brain tumor of any primary origin
Epileptic focus requiring surgical resection
Disqualifiers
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 design
Design model
Parallel
Treatments tested in this trial
Microdialysis
Procedure/SurgeryUndergo microdialysis
Magnetic Resonance Imaging
Procedure/SurgeryUndergo MRI
Computed Tomography
Procedure/SurgeryUndergo CT
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Cohort I (intra-operative microdialysis)Experimental treatment 2 interventions
Group B: Cohort II (post-operative microdialysis)Experimental treatment 3 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
Up to 42 days2
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.
Time frame
Up to 42 daysSecondary outcomes
1
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.
Time frame
Up to 42 days2
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.
Time frame
Up to 42 days3
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.
Time frame
Up to 42 daysSponsors and contacts
Click on the lead sponsor to view all of their trials.
Mayo Clinic
Lead sponsor
National Cancer Institute (NCI)
Collaborator
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborator
Source ClinicalTrials.gov