Key Points
- A team at the Mayo Clinic is seeking to better understand how blood-brain barrier (BBB) opening affects the tumor microenvironment.
- This research may inform future studies exploring how focused ultrasound can enhance the delivery and evaluation of therapeutic agents.
A new clinical trial has begun that will assess how focused ultrasound–mediated blood-brain barrier (BBB) opening affects a brain tumor’s extracellular microenvironment and the composition of molecules in and around the tumor.
The study (NCT05733312) is being led by Terry C. Burns, MD, PhD, a neurosurgeon at the Mayo Clinic in Rochester, Minnesota. Six participants with large (≥ 3 cm) gliomas who are scheduled for routine surgical tumor resection will undergo noninvasive focused ultrasound–enabled BBB opening to a targeted region of the tumor and adjacent tissue immediately before surgery.
During the surgical resection, the team will insert microdialysis catheters into the region that was treated with focused ultrasound as well as untreated areas. The aim is to measure the exact concentrations of any drugs administered as part of routine clinical care and the imaging agents used during surgery. Investigators are seeking to better understand how BBB opening affects the tumor microenvironment and the contribution of blood-derived compounds, including antibiotics, medications, and contrast agents. This information may inform future studies exploring how focused ultrasound can enhance the delivery and evaluation of therapeutic agents.
“While we are seeing increasing amounts of BBB opening in patient care with very few adverse consequences, there are still areas that are unknown,” said Tim Meakem, MD, co-managing director of the Foundation’s Research and Education Team. “This study will provide insight into what impact BBB opening has on many common therapies in the tumor microenvironment to help configure the administration of these medicines in an enhanced manner.”
“BBB leakiness is a common feature of gliomas, which impact the chemical signals and nutrients available to certain regions of the tumor,” said Dr. Burns. “Our microdialysis studies performed immediately prior to surgical removal have provided a unique window into the metabolic features of human gliomas. This new study will help us address fundamental chicken-and-egg questions to better understand what changes are due to the tumor itself, which are due to BBB disruption, and which are due to interactions between the tumor and a disrupted BBB. We are excited to learn from directly within the living human glioma how its unique biology could be leveraged to improve therapy.”
The Foundation is funding this clinical trial, which uses Insightec’s Exablate Neuro focused ultrasound device and Definity microbubbles for BBB opening.
For Patients
To learn more about this study, visit the clinical trial page or contact:
Neurologic Surgery Research Team
507-266-6858
[email protected]
Clinical Trials Referral Office
855-776-0015
[email protected]