Guest Editorial Special Issue on Pilot Clinical Translation of New Medical Ultrasound Methodologies

Ultrasound imaging is uniquely relevant in the modern era of clinical medicine. While the fundamental platform remains low-cost and portable, meeting demands for cost-efficient diagnostic and therapeutic options in the context of constrained medical resources, technology development races forward to achieve applications that were not possible just years ago. A vital first step to translating these cutting-edge ultrasound methods to clinical implementation is performing pilot studies in humans, in vivo. Initial human studies are critical because they demonstrate the feasibility of new methodologies in the context of complex tissue environments with unknown parameters and when penetration requirements and complicated noise sources interfere with signal detection. Furthermore, developing methods for validating outcome measures in the complex and unknown in vivo human setting is difficult. Finally, the logistics associated with obtaining regulatory approval for conducting human studies, the time required to recruit subjects, and the associated expenses compound the technical challenges.