How focused ultrasound opening the blood–brain barrier changes the tumor surroundings

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Researchers will perform MR-guided focused ultrasound (FUS) immediately before standard surgical removal of large gliomas and then place microdialysis catheters into regions exposed and unexposed to FUS to sample interstitial fluid. Plasma and interstitial fluid will be analyzed for metabolites and concentrations of routine perioperative drugs and imaging agents to map changes in the extracellular tumor microenvironment. Intraoperative CT or O-arm with contrast will document catheter positions relative to tumor and FUS-treated regions. The goal is to clarify how blood-derived compounds and drug penetration change after FUS and to enable future use of microdialysis to study pharmacokinetics and pharmacodynamics of therapies delivered with FUS.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Clinical and radiographic evidence suggesting a diagnosis of a diffuse glioma, or a prior diagnosis of a diffuse glioma, which is large enough (≥3cm) for half of the tumor to be targeted by FUS, but small enough for the standard-of-care resection to incorporate some regions of relatively normal brain adjacent to tumor.
* Planned neurosurgical resection of this suspected or previously diagnosed brain tumor as part of routine clinical care.
* Provide written informed consent for the current study and the Neuro-Oncology biorepository for archiving of microdialysate and blood samples collected on this protocol.
* ECOG performance status (PS) 0, 1, or 2. Willing to undergo neurosurgical resection at Mayo Clinic (Rochester, MN).

Exclusion Criteria:

* Patients who are not appropriate surgical candidates due to current or past medical history or uncontrolled concurrent illness which limits safety of or compliance to study proceedings.
* Vulnerable populations: pregnant or nursing women, prisoners, mentally handicapped.
* Contraindication to Definity®.
* Cardiac disease or coagulative disease (such as cerebral or systemic vasculopathy, abnormal platelets, documented MI within 6 months of enrollment, pacemaker, hemodynamically unstable cardiac arrhythmia, unstable congestive heart failure, or left ventricular ejection fraction \<50%), that would preclude the use of Definity ®, FUS-induced BBB disruption, or surgical resection.
* Any blood-borne infection that may lead to meningitis or brain abscess due to BBB-disruption.
* Active seizure disorder that is not attributable to the patient's tumor which is not controlled by medication or due to active drug or alcohol disorder which may be worsened by BBB-disruption.
* Patients for whom the surgeon feels 5-ALA would be required to perform an optimal resection, since 5-ALA will not be permitted for patients participating in this study.
* Patients who are at risk of FUS-related complications due to potential risks associated with skull anatomy as determined by pre-operative CT assessment, based on skull thickness, curvature, density, or other features that would increase the risk of skull complications with FUS.

Where it's running

• Mayo Clinic Minnesota
  Rochester, Minnesota, United States Recruiting

Study contacts

• Principal investigator: Terence C. Burns, MD, PhD — Mayo Clinic
• Study coordinator: Neurologic Surgery Research Team
• Email: hoplin.matthew@mayo.edu
• Phone: 507-266-6858

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.