Ensayos clínicos

Inclusion Criteria:

• Age ≥ 18 years.
• 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.
• Willingness of the patient or an authorized representative to 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.
• Patients with previous confirmed or suspected allergic reaction to the contrast agents.

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

Eligibility last updated 9/25/23. Questions regarding updates should be directed to the study team contact.