Traditionally, surgery has been considered as the standard cure for various solid tumors. However, advancements in technology have led to a shift away from open surgery towards less invasive methods 1. In recent years, focused ultrasound (FUS) therapy, also known as high intensity focused ultrasound (HIFU), has emerged as a potential solution for non-invasive tumor ablation 2. FUS is an image-guided therapy that uses ultrasound beam to target and treat cancerous tumors. The principles of FUS are similar to conventional ultrasound imaging, where ultrasonic waves can pass harmlessly through living tissue. However, when the energy of the ultrasound beam is focused at high intensity, it can cause a rise in temperature, leading to tissue heating 3. During FUS treatment, the temperature at the focused region can quickly rise above 80°C, causing effective cell death even with short exposure times 4. FUS is performed on an outpatient basis, requires no incisions, and can result in rapid recovery time, with the potential to improve the lives of millions of patients5. Currently, FUS is offered at 799 treatment sites worldwide, to treat various solid tumors, including the prostate 6–8, liver 9–11, breast 12–14, kidney 15–17, and bone 18–20.
A successful tumor treatment with FUS requires precise guidance and delivery of ultrasound energy to the target site 21. This can be accomplished through the integration of FUS with a medical imaging modality. Diagnostic ultrasound can provide an acceptable solution for FUS guidance, allowing for real-time monitoring of therapeutic results and the control of the FUS procedure for complete tumor ablation 22. Ultrasound-guided FUS (USgFUS) can be achieved through hyperechogenicity, where the ablated tissue and therapeutic effects can be evaluated through changes in the grayscale of conventional B-mode images 23. Ultrasound imaging offers several benefits for FUS guidance, including lower cost and accessibility, faster treatment times, and a strong correlation between the observed ultrasound changes and the region of necrosis in the tissue 24. USgFUS was first proposed in the early days of diagnostic ultrasound in the 1970s and remains one of the leading image-guided techniques for clinical FUS treatment 24. Over the past decade, several USgFUS devices have been received regulatory approval for solid tumor treatment, including Sonablate® 500 (by Focus Surgery Inc. based in Indianapolis, IN) and Ablatherm® HIFU (by EDAP TMS S.A. based in Vaulx-en-Velin, France) for the treatment of prostate cancer, and Chongqing HAIFU (by Chongqing Haifu Technology Co. Ltd. based in Chongqing, China) and FEP-BY HIFU System (by China Medical Technologies Inc. based in Beijing, China) for various extra-corporeal FUS treatments 25.
Despite its clinical approval, USgFUS has not yet achieved widespread clinical acceptance and reached its full market potential. A significant challenge of USgFUS lies in the precision of monitoring with conventional B-mode imaging 21. Specifically, it is not possible to measure temperature rise during FUS treatment with diagnostic ultrasound, resulting in a lack of quantitative measurement of thermal dose and precise imaging of the ablated volume 22. Therefore, the success of monitoring during USgFUS treatment completely relies on the accuracy of detecting grayscale changes on B-mode images while ultrasound imaging does have limited spatial and contrast resolution 22. Besides, the appearance of hyperechoic spots during the USgFUS treatment necessitates overheating the focused area to generate boiling bubbles, resulting in the formation of ablated areas with unpredictable shapes. It has been also proven that the hyperechoic spots appearing on B-mode images can fade after FUS exposure ends 26. Due to the lack of precise monitoring in current USgFUS devices, the physicians performing the treatment require extensive training, and therapeutic results are highly dependent on their expertise and experience.
The need for an accurate method for monitoring FUS becomes even more critical when complete tumor ablation requires the control and monitoring of a number of ablation procedures to cover the entire tumor 27. The absence of precise monitoring mechanism increases the risk of cancerous cell survival in the spaces between small ablated regions 1. To mitigate this, physicians often target and ablate a volume larger than the targeted tumor and repeat the sonication process to ensure complete tumor ablation. This can result in long treatment time and major side effects, such as collateral damages to healthy tissue and rectal wall burns during the FUS prostate treatment 28,29. Consequently, these limitations have prevented USgFUS from realizing its full market potential despite its overall benefits to patients. For instance, only \(6\%\) of \(\text{148,000}\) eligible patients with prostate cancer received FUS treatment in \(2020\), according to the Focused Ultrasound Foundation.
Recognizing the exceptional capabilities of ultrasound imaging, numerous studies have aimed to develop new methods and systems for USgFUS to enhance monitoring accuracy and improve therapeutic results. Various researchers have investigated alternative techniques for USgFUS, such as local harmonic motion (LHM) 30, amplitude-modulated (AM) harmonic motion imaging 31, ultrasound elastography 32, contrast-enhanced ultrasonography 33, and ultrasonic Nakagami imaging 34. Although these methods have shown promising potential for improving USgFUS procedures, it is crucial to acknowledge that they have not yet received clinical approval 24. At present, clinical USgFUS predominantly relies on conventional ultrasound B-mode imaging for providing feedback during the ablation procedures 25. Consequently, there is an urgent need for the development of new monitoring methods that enable physicians to administer USgFUS more accurately and efficiently, utilizing ultrasound hyperechogenicity.
This paper proposes the concept of Artificial Intelligence (AI)-assisted USgFUS, a novel approach that uses a trained AI segmentation framework in combination with diagnostic ultrasound to accurately identify and label the ablated areas in the ultrasound B-mode images captured during and after each FUS sonication procedure (Fig. 1). To implement this approach, we developed an AI framework based on Swin-Unet architecture. The developed AI framework was employed in conjunction with ultrasound B-mode imaging to fulfil the demand for real-time and quantitative monitoring of ablated area during FUS ablation procedures. To assess the feasibility of our proposed AI-assisted USgFUS framework, we conducted an in vitro experimental study using an USgFUS setup and chicken breast tissue. Initially, we trained a supervised AI framework on \(90\%\) of the experimental data, and then evaluated the real-time labeling performance of the trained AI network using the remaining \(10\%\) of the experimental data. The results presented in this paper demonstrate the accuracy and feasibility of using AI-assisted USgFUS for precise and quantitative monitoring of FUS treatment.