Glioblastoma, Glioma
Conditions
Brief summary
The purpose of this study is to evaluate the safety and feasibility of intra-operative microperfusion during a planned neurosurgical resection of diseased brain parenchyma, including either an epileptic focus requiring temporal lobectomy or a glioma. Devices used for microperfusion are Joanneum Research cerebral open flow microperfusion (OFM) catheters, push and pull tubing, and MPP102-II pump.
Interventions
DEVICECerebral open flow microperfusion
Patients will undergo intra-operative microperfusion using Joanneum Research's cerebral open flow microperfusion (OFM) catheters, push and pull tubing, and MPP102-II pump. This process utilizes a probe (catheter) inserted into the parenchyma to collect analytes of any size and polarity from the microenvironment. The microperfusion pump peristaltically pushes and pulls perfusate with no net fluid-exchange when the pump heads are set at equal flow rates. As perfusate enters the tip of the microperfusion catheter, analytes are exchanged based on a gradient between the interstitial fluid and the perfusate. The sample is then recovered via the "pull" portion of the peristaltatic microperfusion pump, enabling constant sampling volumes and preventing loss of the perfusate into the tissue. The duration is 60-80 minutes (dependent on the speed of progress resecting portions of the tumor without catheters)
Sponsors
Mayo Clinic
National Cancer Institute (NCI)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* ECOG performance status (PS) 0, 1 or 2. * Clinical and radiographic evidence diagnosis of glioma, or a prior diagnosis of glioma (suspected WHO grade II-IV), OR clinical evidence of epileptic foci requiring a temporal lobectomy. * Clinical indication for resection as part of routine clinical care, with plan for this to be performed at Mayo Clinic (Rochester, MN). * Able and willing to provide informed consent either signed by themselves or a legally authorized representative.
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. * Patients whom the surgeon deems to be at increased risk of adverse effects from the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events | 1 year | Number of patients who develop persistent adverse events deemed related (possibly, probably, definitely) to the insertion or use of microperfusate catheters. Adverse events will be measured by CTCAE 5.0. |
| Sample collection | 1 year | Number of patients for whom at least 1 specimen containing \> 10 μL microperfusate is successfully collected from 2 or more locations. |
Countries
United States
Contacts
CONTACTNeurologic Surgery Research Team
PRINCIPAL_INVESTIGATORTerence Burns, MD
Mayo Clinic
Outcome results
None listed