Feasibility of Intra- and Post-operative Microdialysis During Neurosurgery for Central Nervous System Lesions

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
Mayo Clinic
Study ID
NCT04047264
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Microdialysis — PROCEDURE
    Undergo microdialysis
  • Magnetic Resonance Imaging — PROCEDURE
    Undergo MRI
  • Computed Tomography — PROCEDURE
    Undergo CT

Study Details

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.

Key Dates

First listed
Aug 6, 2019
Start date
Jan 1, 2020
Status verified
Aug 2026
Primary completion
Sep 1, 2027
Completion
Sep 1, 2027

Study Design

Enrollment
100 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

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.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo Clinic in RochesterRochesterMinnesota55905
Clinical Trials Referral Office
[email protected]
855-776-0015
Terence C. Burns, MD, PhD (PRINCIPAL_INVESTIGATOR)

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