Clinical trial · Interventional
A Study for Cerebral Open Flow Microperfusion
A Pilot Feasibility Study for Cerebral Open Flow Microperfusion in Patients Undergoing Planned Neurosurgical Resection of Diseased Parenchyma.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Glioblastoma | Glioblastoma | CURATED_BROADER | 0.80 |
| Glioma | Glioma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cerebral open flow microperfusion | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Study Group
- description
- Patients undergoing a planned neurosurgical resection of diseased brain parenchyma.
- interventionNames
- Device: Cerebral open flow microperfusion
Primary outcomes (2)
- measure
- Adverse events
- timeFrame
- 1 year
- description
- 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.
- measure
- Sample collection
- timeFrame
- 1 year
- description
- Number of patients for whom at least 1 specimen containing \> 10 μL microperfusate is successfully collected from 2 or more locations.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available