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NCT Number: NCT07089758

A Study for Cerebral Open Flow Microperfusion

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.

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Key information

Conditions

Glioma Astrocytoma Glioblastoma Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neuroectodermal Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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)

Other names: Joanneum Research cerebral open flow microperfusion

Primary outcomes

  1. Adverse events

    Time frame: 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.

  2. Sample collection

    Time frame: 1 year

    Number of patients for whom at least 1 specimen containing > 10 μL microperfusate is successfully collected from 2 or more locations.

Study contacts

Contact information is provided by the study sponsor or research team.

Neurologic Surgery Research Team

CONTACT

507-538-6342

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

A Pilot Feasibility Study for Cerebral Open Flow Microperfusion in Patients Undergoing Planned Neurosurgical Resection of Diseased Parenchyma.

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jul 28, 2025
Registry last updated
Mar 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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