Regulatory Science for Engineering Intuitive, Engaging, Safe and Effective Human-Device Interaction
(Yunbo Liu, FDA)
Background: The first pediatric brain tumor patient recently successfully underwent an image-guided focused ultrasound therapy. The treatment, performed on a 5-year-old child diagnosed with a diffuse intrinsic pontine glioma (DIPG), was done noninvasively through an intact skull under real-time MRI imaging guidance of ultrasonic energy. High Intensity Therapeutic ultrasound (HITU), propagating noninvasively through an intact pediatric skull without open surgery, is a novel way to treat these very deep-seated lesions that have been highly resistant to all forms of therapy and is potentially the greatest breakthrough in pediatric tumor management. Ultrasound scientists at FDA/CDRH have a long track record of developing ultrasound tissue mimicking phantom as a critical bench testing tools for HITU device characterization to establish safety and effectiveness before larger scale clinical trials can be initiated.
Research Plan: The aim of this study is to characterize a clinical-based brain tissue mimicking phantom material specifically for pediatric population to promote transcranial treatment planning and efficacy. This engineering testbed will simulate both brain ultrasound properties and clinical physiology acquired during pediatric brain ultrasound tumor treatments. Such a regulatory bench testing tool study, combined with additional numerical simulation (Matlab), will leverage existing large pooled clinical information and post-market scientific resource to promote transcranial pediatric ultrasound therapy. Key aspects for this experimental and numerical combination study will include advanced engineering characterization coupled with acoustic uncertainty simulation using commercial software. This regulatory science tool study will provide technical insights during clinical HITU transcranial treatment planning and patient monitoring.
Prerequisites: Engineering coursework in (1) Math, (2) Physics, (3) numerical modeling or scientific computing, and (4) 1+ years of programming experience in MATLAB and/or Python. Knowledge of solid mechanics, acoustics, or heat transfer will be a plus.
Dr. Yunbo Liu is a Mechanical Engineer with a background in medical ultrasound metrology including tissue phantom development, acoustic output measurements and ultrasound microbubble characterization. Dr. Liu holds a Ph.D. in Mechanical Engineering from the Duke University and is currently affiliated with the Division of Applied Mechanics in the Office of Science and Engineering Laboratories, Center for Devices and Radiological Health, U.S. Food and Drug Administration.