Feasibility of Intraoperative Microdialysis During Neurosurgery for Central Nervous System Malignancies

NCT04047264 | Recruiting DMC FDA Device

• 4 other identifiers: 19-004694NCI-2021-02742R37CA276851R61NS122096
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Glioma; Glioblastoma; Metastatic Malignant Neoplasm in the Brain

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Up to 42 days

Secondary Outcomes (3)

• Microdialysate D-2HG

  Up to 42 days

• Non-enhancing (FLAIR)- region metabolites

  Up to 42 days

• Necrotic core metabolites

  Up to 42 days

Other Outcomes (1)

• Microdialysate oncometabolites

  Up to 42 days

Study Arms (1)

Basic Science (microdialysis)

EXPERIMENTAL

Patients undergo microdialysis over 30 minutes during standard of care biopsy or resection.

Procedure: Microdialysis; Procedure: Magnetic Resonance Imaging

Interventions

Microdialysis PROCEDURE

Undergo microdialysis

Basic Science (microdialysis)

Magnetic Resonance Imaging PROCEDURE

Undergo MRI

Also known as: 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

Basic Science (microdialysis)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 \[MN\])
• Ability to understand and the willingness to sign a written informed consent document

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead
• National Cancer Institute (NCI): collaborator
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

Related Publications (1)

• 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.

  PMID: 38115038 DERIVED

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Glioma; Glioblastoma; Brain Neoplasms

Interventions

Microdialysis; Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Astrocytoma; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Dialysis; Chemistry Techniques, Analytical; Investigative Techniques; Spectrum Analysis

Study Officials

• Terence C Burns, MD, PhD

  Mayo Clinic in Rochester

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Trials Referral Office

CONTACT

855-776-0015; mayocliniccancerstudies@mayo.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2019
• First Posted: August 6, 2019
• Study Start: January 1, 2020
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: February 12, 2026

Record last verified: 2026-02

Locations

US (1)