Quality assurance for focused ultrasound-induced blood-brain barrier opening procedure using passive acoustic detectionResearch in context
Chih-Yen Chien,
Lu Xu,
Jinyun Yuan,
Siaka Fadera,
Andrew H. Stark,
Umeshkumar Athiraman,
Eric C. Leuthardt,
Hong Chen
Affiliations
Chih-Yen Chien
Department of Biomedical Engineering, Washington University in St. Louis, Saint Louis, MO, 63130, USA
Lu Xu
Department of Biomedical Engineering, Washington University in St. Louis, Saint Louis, MO, 63130, USA
Jinyun Yuan
Department of Biomedical Engineering, Washington University in St. Louis, Saint Louis, MO, 63130, USA
Siaka Fadera
Department of Biomedical Engineering, Washington University in St. Louis, Saint Louis, MO, 63130, USA
Andrew H. Stark
Department of Biomedical Engineering, Washington University in St. Louis, Saint Louis, MO, 63130, USA
Umeshkumar Athiraman
Department of Anesthesiology, Washington University School of Medicine, St. Louis, MO, 63110
Eric C. Leuthardt
Department of Biomedical Engineering, Washington University in St. Louis, Saint Louis, MO, 63130, USA; Department of Neurosurgery, Washington University School of Medicine, St. Louis, MO, 63110, USA; Center for Innovation in Neuroscience and Technology, Washington University School of Medicine, Saint Louis, MO, 63110, USA; Department of Mechanical Engineering and Materials Science, Washington University in St. Louis, Saint Louis, MO, 63130, USA; Division of Neurotechnology, Department of Neurosurgery, Washington University School of Medicine, Saint Louis, MO, 63110, USA
Hong Chen
Department of Biomedical Engineering, Washington University in St. Louis, Saint Louis, MO, 63130, USA; Department of Neurosurgery, Washington University School of Medicine, St. Louis, MO, 63110, USA; Division of Neurotechnology, Department of Neurosurgery, Washington University School of Medicine, Saint Louis, MO, 63110, USA; Mallinckrodt Institute of Radiology, Washington University School of Medicine, Saint Louis, MO, 63110, USA; Siteman Cancer Center, Washington University School of Medicine, St. Louis, MO, 63110, USA; Corresponding author. Department of Biomedical Engineering and Neurosurgery, Washington University in St. Louis, USA.
Summary: Background: Focused ultrasound (FUS) combined with microbubbles is a promising technique for noninvasive, reversible, and spatially targeted blood-brain barrier opening, with clinical trials currently ongoing. Despite the fast development of this technology, there is a lack of established quality assurance (QA) strategies to ensure procedure consistency and safety. To address this challenge, this study presents the development and clinical evaluation of a passive acoustic detection-based QA protocol for FUS-induced blood-brain barrier opening (FUS-BBBO) procedure. Methods: Ten glioma patients were recruited to a clinical trial for evaluating a neuronavigation-guided FUS device. An acoustic sensor was incorporated at the center of the FUS device to passively capture acoustic signals for accomplishing three QA functions: FUS device QA to ensure the device functions consistently, acoustic coupling QA to detect air bubbles trapped in the acoustic coupling gel and water bladder of the transducer, and FUS procedure QA to evaluate the consistency of the treatment procedure. Findings: The FUS device passed the device QA in 9/10 patient studies. 4/9 cases failed acoustic coupling QA on the first try. The acoustic coupling procedure was repeatedly performed until it passed QA in 3/4 cases. One case failed acoustic coupling QA due to time constraints. Realtime passive cavitation monitoring was performed for FUS procedure QA, which captured variations in FUS-induced microbubble cavitation dynamics among patients. Interpretation: This study demonstrated that the proposed passive acoustic detection could be integrated with a clinical FUS system for the QA of the FUS-BBBO procedure. Funding: National Institutes of Health R01CA276174, R01MH116981, UG3MH126861, R01EB027223, R01EB030102, and R01NS128461.
