A Study for Cerebral Open Flow Microperfusion

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

• Cerebral open flow microperfusion · DEVICE

  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)

Published eligibility criteria

Verbatim from the registry. Only the site can decide how these apply to a specific patient.

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.

Sites (1)

• Mayo Clinic in Rochester, Rochester, Minnesota