The safety and feasibility of extracorporeal high-intensity focused ultrasound (HIFU) for the treatment of liver and kidney tumours in a Western population

Abstract

High-intensity focused ultrasound (HIFU) provides a potential noninvasive alternative to conventional therapies. We report our preliminary experience from clinical trials designed to evaluate the safety and feasibility of a novel, extracorporeal HIFU device for the treatment of liver and kidney tumours in a Western population. The extracorporeal, ultrasound-guided Model-JC Tumor Therapy System (HAIFU Technology Company, China) has been used to treat 30 patients according to four trial protocols. Patients with hepatic or renal tumours underwent a single therapeutic HIFU session under general anaesthesia. Magnetic resonance imaging 12 days after treatment provided assessment of response. The patients were subdivided into those followed up with further imaging alone or those undergoing surgical resection of their tumours, which enabled both radiological and histological assessment. HIFU exposure resulted in discrete zones of ablation in 25 of 27 evaluable patients (93%). Ablation of liver tumours was achieved more consistently than for kidney tumours (100 vs 67%, assessed radiologically). The adverse event profile was favourable when compared to more invasive techniques. HIFU treatment of liver and kidney tumours in a Western population is both safe and feasible. These findings have significant implications for future noninvasive image-guided tumour ablation.

Figure 1

Patient disposition.

Figure 2

(A) Right chest wall. Grade 1 skin toxicity following intercostal HIFU treatment to a liver metsastasis. (B) Close-up of lesion showing scale.

Figure 3

Axial FAME series MRI images, 1 min post IV gadolinium contrast. (A) Before HIFU with a right hepatic metastasis within segment VIII showing central necrosis, and (B) 12 days after HIFU, a larger zone consistent with coagulation necrosis within the metastasis.

Figure 4

Subtraction MRI films, taking the FAME precontrast series from the 1 min postcontrast images. Patient with a right primary renal tumour (A) before HIFU showing contrast uptake within the target tumour, and (B) 12 days after HIFU, showing no contrast uptake within the target tumour, consistent with ablation.