Intraoperative Microdialysis During Neurosurgery for Central Nervous System Malignancies

  • STATUS
    Recruiting
  • End date
    Sep 1, 2022
  • participants needed
    16
  • sponsor
    Mayo Clinic
Updated on 2 August 2021

Summary

Microdialysis permits sampling of molecules from the extracellular fluid, and has been utilized for studies of pharmacokinetics, and recovery of biomarkers. Gliomas remain incurable--in part due to limited access to human tumor biology in available preclinical models. This study utilizes a variable rate pump (M dialysis 107) and a high molecular weight cut-off catheter (71 high cut-off brain microdialysis catheter) to recover an expanded range of potential biomarkers from the diseased human central nervous system in the context of surgery for brain tumors. This study is performed under an investigational device exemption for use of these clinical grade devices that are not otherwise FDA approved for general use. The study will evaluate the safety of these devices and the feasibility of their use to collect analytes with sizes up to 100kDA. Analysis will be performed to evaluate the yield of oncometabolites and other potential biomarkers in appropriate regions of tumor and brain adjacent to tumor. Data obtained from analysis of samples collected will facilitate the design of future observational and interventional studies for central nervous system malignancies.

Details
Condition Microdialysis
Treatment Intraoperative cerebral microdialysis using M dialysis 107 pump and 71 High cut-off brain microdialysis catheter
Clinical Study IdentifierNCT04047264
SponsorMayo Clinic
Last Modified on2 August 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Age > 18 years
ECOG performance status (PS) 0, 1 or 2
Clinical and radiographic evidence suggesting a diagnosis of a diffuse glioma, or a prior diagnosis of a diffuse glioma
Suspected primary brain neoplasm include astrocytoma, anaplastic astrocytoma, glioblastoma, oligodendroglioma and anaplastic oligodendroglioma
Planned neurosurgical procedure for purposes of biopsy or resection of suspected or previously diagnosed brain tumor as part of routine clinical care
Willing to undergo neurosurgical resection or biopsy at Mayo Clinic (Rochester, MN)
Ability to understand and the willingness to sign a written informed consent document

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
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