An Integrated Harmonic Motion Imaging-Guided Focused Ultrasound System (HMIgFUS) for Breast Cancer Ablation and Monitoring in the Clinic

Focused ultrasound surgery (FUS) is a novel treatment modality for breast tumors. It is clinically advantageous due to its non-invasive and non-radiative characteristics, leading to a shorter recovery time and improved cosmetic outcomes. The spatially confined focused ultrasound beam deposits high energy into the targeted tissue, causing fast temperature rises, sufficient to induce immediate cell death, while leaving the surrounding tissue unaffected. Given these promises, widespread clinical adoption is hampered by the lack of reliable monitoring methods that ensure the treatment safety and efficacy. This study develops an integrated clinical system, Harmonic Motion Imaging-Guided Focused Ultrasound Surgery (HMIgFUS) for treatment targeting, ablation, and real-time monitoring. We performed HMIgFUS in two breast cancer patients (N = 2), with benign and malignant tumors, and monitored the direct treatment effects, i.e., tissue conditions in real time. To the authors’ best knowledge, this is the first study that demonstrates the clinical feasibility of a theranostic ultrasound system that can perform ablation and real-time monitoring simultaneously.