First FDA approved experience with histotripsy for liver cancer management

Cristina Jimenez-Soto; Matthew M Byrne; Abigail Loszko; Yutaka Endo; Amit Nair; Roberto Hernandez-Alejandro; Daniel Oppenheimer; Deborah Rubens; Andrew Clark; Yuki Bekki; Koji Tomiyama

doi:10.1097/JS9.0000000000004070

First FDA approved experience with histotripsy for liver cancer management

Int J Surg. 2025 Nov 19. doi: 10.1097/JS9.0000000000004070. Online ahead of print.

Affiliations

¹ Transplant Institute, University of Rochester Medical Center, Rochester, NY, USA.
² Department of Surgery, University of Rochester Medical Center, Rochester, NY, USA.
³ Department of Imaging Sciences, University of Rochester Medical Center, Rochester, NY, USA.

PMID: 41255274
DOI: 10.1097/JS9.0000000000004070

Abstract

Background: Histotripsy is a novel, non-invasive, focused ultrasound therapy that mechanically disrupts targeted tissues through cavitation, offering a precise and non-thermal alternative to conventional locoregional therapies with preservation of vascular and biliary structures. There are limited reports on the early use of histotripsy in primary and secondary liver tumors.

Materials and methods: Patients undergoing histotripsy for the treatment of primary and secondary liver tumors were retrospectively analyzed. The response to histotripsy was evaluated assessing computed tomography (CT) findings in the first three months post-procedure period.

Results: Twenty-seven patients were included in the study. Nine (33%) received histotripsy with downstaging or bridging intent, whereas eighteen (67%) received histotripsy as part of a palliative treatment approach. Among patients with downstaging or bridging intent, 7/8 (87.5%) evaluable patients showed no lesion growth ≤3 months post-procedure. In palliative patients, growth remained controlled during the first 3 months in 3/9 (33%) cases, while increasing in the remaining 6 (67%). Interestingly, tumoral size decreased in tumors not targeted by histotripsy in four patients, including one palliative patient who was not responding to multiple prior treatments. After histotripsy, three patients were successfully downstaged for liver resection and five were eligible for liver transplantation.

Conclusion: Histotripsy presents great potential for the treatment of liver tumors, achieving high rates of short-term local disease control while offering vascular and biliary protection advantages, unlike thermal methods. Further work is required to understand a possible response away from the target. Histotripsy, in combination with systemic therapies, could aid in bridging or downstaging patients with advanced disease to achieve surgical resection or transplantation.

Keywords: bridging; downstaging; histotripsy; liver metastasis; liver tumors; liver-directed therapies.