Histotripsy Treatment for Primary and Metastatic Liver Tumors

Results from the #HOPE4LIVER US Trial

The single-arm, non-randomized, multicenter, prospective trial evaluated the efficacy and safety of the HistoSonics System for the treatment of primary or metastatic tumors located in the liver. This study was conducted in 2 parts: one in the US and one in the UK/Europe.

First results from this trial were reported by Mishal Mendiratta-Lala, MD, University of Michigan, West Bloomfield, at the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) 2023 Annual Meeting in Copenhagen, Denmark.

Of the 47 patients enrolled between the 2 trials (23 treated in US; 24 treated in Europe), 40 were evaluable, with 44 primary or metastatic liver tumors. Patients underwent histotripsy treatment, a non-thermal, mechanical process using focused ultrasound, with the HistoSonics System. Imaging was done ≤36 hours following the treatment to determine technical success, with additional follow-up for 30 days and evaluation at 6 months and then annually for up to 5 years.

In the first-in-human, phase 1 THERESA trial, enrolled 8 patients with primary or metastatic liver tumors. The primary end point was acute technical success with safety as a secondary end point. As previously reported, results from this trial found histotripsy to be well tolerated with no adverse events attributed to the treatment device. The primary end point was achieved in all procedures.

Of the 44 tumors evaluating, 42 were treated successfully, correlating to a primary efficacy of 95.5%. Dr Mendiratta-Lala noted that the 2 tumors not successfully treated were due to “user error, not device error.” Additionally, there were 3 complications (6.8%) from risks associated with focal liver therapies that are not unique to histotripsy.

There are limitations to this study, as it is a small cohort of heterogenous patients, recruited at an already advanced stage of disease. Because of this, while the results demonstrated the effect of histotripsy tissue destruction, the direct effect on the disease process was not evaluated.

Despite the limitations, this trial did meet its primary safety and efficacy end points, “demonstrating successful, non-invasive destruction of liver tissue via histotripsy.”

Sources:

HistoSonics, Inc. The HistoSonics System for treatment of primary and metastatic liver tumors using histotripsy (#HOPE4LIVER US). NCT04572633. January 27, 2021. Accessed April 23, 2024. https://www.clinicaltrials.gov/study/NCT04572633.

Mendiratta-Lala M. The HistoSonics System for the destruction of liver tissue: First report of primary safety and efficacy from #HOPE4LIVER trials. Presented at 2023 CIRSE Annual Meeting. September 9-13, 2023; Copenhagen, Denmark.

Vidal-Jove J, Serres X, Vlaisavljevich E, et al. First-in-man histotripsy of hepatic tumors: The THERESA trial, a feasibility study. Int J Hyperth. Published online August 24, 2022. doi:10.1080/02656736.2022.2112309