Abstract
The aim of this study was to assess the feasibility, safety and accuracy of HIFU ablation in patients with liver metastases in a prospective, phase I-II trial. The transducer has a toroidal shape (diameter: 70 mm, radius of curvature: 70 mm) and was divided into 32 ring-shaped emitters operating at 3 MHz. Twenty-eight patients were included. HIFU ablations were created to ablate metastases (20 mm maximal diameter) with safety margins in all directions. The exposure time varied from 40 seconds to 370 seconds according to the diameter of the metastases to be treated. One metastasis of 10 mm in diameter was ablated in 40 seconds with safety margins. Using electronic focusing metastases of 2 cm in diameter were ablated with safety margins (> 3 mm in all directions) in 370 seconds. The dimensions of these HIFU ablations were a diameter of 48 ± 4.9 mm and a long axis of 51 ± 3.4 mm. No damage occurred to neighboring tissues. This HIFU device safely achieved ablations of small metastases (< 20 mm) with planned safety margins of at least 3 mm in all directions. This study is the first clinical use of intra-operative HIFU in patients with liver metastases.
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