Fig. 2

Schematics of the Part 1 (a) and Part 2 (b) study interventions highlighting the key differences between both parts of the study. The patient lies over the degassed water bath of the FUS device (JC200), which contains an ultrasound-guided therapeutic transducer, such that the focus of the transducer is aligned with the target tumour through the relevant intercostal space. (a) Part 1 of the study involves insertion of a co-axial needle into the target liver tumour under ultrasound guidance. This needle is used to take core biopsies of the tumour before and immediately after ThermoDox® infusion, and finally after FUS-mediated delivery, which are used in evaluation of the primary endpoint. In addition, the co-axial needle is used to pass a clinically approved thermometry device during FUS exposure, for real-time thermometry. (b) Part 2 does not require a thermistor, and FUS is applied to the target tumour following ThermoDox® infusion. Targeted drug delivery is thus performed completely non-invasively. Two serial core biopsies of the target tumour are taken following the FUS exposure, and tissue is used in evaluation of the primary endpoint. Part 2 affords more flexibility in patient positioning, and the supine position shown is illustrative only