Recruiting

Observational Study

Sponsor:

Mayo Clinic

Code:

NCT04047264

Conditions

Glioma

Glioblastoma

Metastatic Malignant Neoplasm in the Brain

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Microdialysis

Magnetic Resonance Imaging

Computed Tomography

Study Details

Brief 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. Information collected in this study may help doctors develop new strategies to better diagnose, monitor, and treat brain tumors.

Conditions

Glioma

Glioblastoma

Metastatic Malignant Neoplasm in the Brain

Study ID

NCT04047264

Start date

Jan 1, 2020

Status verified date

Aug, 2026

Completion date

Sep 1, 2027

Anticipated

Primary completion date

Sep 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

100 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

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.

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.

Interventions

Microdialysis

Undergo microdialysis

Magnetic Resonance Imaging

Undergo MRI

Computed Tomography

Undergo CT

Primary outcome measure

  • Incidence of adverse events [ Time Frame: Up to 42 days ]
  • Targeted metabolomics [ Time Frame: Up to 42 days ]

Central Contacts and Locations

Central contacts

Clinical Trials Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

Locations

Mayo Clinic in Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Clinical Trials Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

Principal Investigator:

Terence C. Burns, MD, PhD

More Information

Sponsor

Mayo Clinic

Last update posted

Aug 18, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-08-18.