Mayo Clinic in Rochester
Rochester, Minnesota, 55905, United States
Location status: Recruiting
Location contact
Clinical Trials Referral Office
CONTACT
Terence C. Burns, MD, PhD
PRINCIPAL_INVESTIGATOR
NCT Number: NCT04047264
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Rochester, Minnesota, 55905, United States
Location status: Recruiting
Clinical Trials Referral Office
CONTACT
Terence C. Burns, MD, PhD
PRINCIPAL_INVESTIGATOR
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Undergo microdialysis
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
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.
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.
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.
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.
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.
Time frame: Up to 42 days
Will be assessed by untargeted metabolomic analyses will be tabulated and evaluated for hypothesis generation.
Contact information is provided by the study sponsor or research team.
Mayo Clinic
Other
Intraoperative Microdialysis During Neurosurgery for Central Nervous System Malignancies
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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