A Study for Cerebral Open Flow Microperfusion

Overview

About this study

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’s cerebral open flow microperfusion (OFM) catheters, push and pull tubing, and MPP102-II pump.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Age > 18 years.
  •  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.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 02/10/2025. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Terence Burns, M.D., Ph.D.

Contact us for the latest status

Contact information:

Essa Sharif

(507) 538-6342

Sharif.Essa@mayo.edu

More information

Publications

Publications are currently not available