A Study for Cerebral Open Flow Microperfusion

NCT07089758 | Not Yet Recruiting DMC FDA Device

• 2 other identifiers: 25-001538R37CA276851
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Glioma; Glioblastoma

Outcome Measures

Primary Outcomes (2)

• Adverse events

  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.

  1 year

• Sample collection

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

  1 year

Study Arms (1)

Study Group

EXPERIMENTAL

Patients undergoing a planned neurosurgical resection of diseased brain parenchyma.

Device: Cerebral open flow microperfusion

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)

Also known as: Joanneum Research cerebral open flow microperfusion

Study Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Glioma; Glioblastoma

Condition Hierarchy (Ancestors)

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

Study Officials

• Terence Burns, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Neurologic Surgery Research Team

CONTACT

507-538-6342

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 25, 2025
• First Posted: July 28, 2025
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): October 1, 2028
• Last Updated: March 23, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)