Histotripsy – pro
In 2022, a study , Theresa, established feasibility of this treatment. A multicenter phase I trial (Theresa Study) was performed in a single country with 8 weeks of planned follow-up, and ti included 8 patients who all had unresectable end-stage multifocal liver tumors: colorectal liver metastases (CRLM) in 5 patients (7 tumors), breast cancer metastases in 1 (1 tumor), cholangiocarcinoma metastases in 1 (2 tumors), and hepatocellular carcinoma (HCC) in 1 (1 tumor). This first-in-human trial demonstrates that hepatic histotripsy effectively destroys liver tissue in a predictable manner, correlating very well with the planned histotripsy volume, and has a high safety profile without any device-related adverse events. Based on these results, the need for more definitive clinical trials is warranted.
Vidal-Jove J, Serres X, Vlaisavljevich E, Cannata J, Duryea A, Miller R, Merino X, Velat M, Kam Y, Bolduan R, Amaral J, Hall T, Xu Z, Lee FT Jr, Ziemlewicz TJ. First-in-man histotripsy of hepatic tumors: the THERESA trial, a feasibility study. Int J Hyperthermia. 2022;39(1):1115-1123. doi: 10.1080/02656736.2022.2112309. PMID: 36002243.
Elfatairy K. First-In-Human Histotripsy Trial for Liver Tumor Treatment: The New Echo Superpower. Radiol Imaging Cancer. 2023 Jan;5(1):e229026. doi: 10.1148/rycan.229026. PMID: 36562709; PMCID: PMC9896221.
Chase J. Wehrle a, Kevin Burns b, Evan Ong c, Allison Couillard d, Neehar D. Parikh e, Elaine Caoili f, JaeKeun Kim a, Federico Aucejo a, Andrea Schlegel a, Emily Knott a, Paul Laeseke d, J. Philip Boudreaux g, Philipp von Breitenbuch h, Mikhail Silk i, Mohamed Alassas c, Andrew Guzowski j, Brian Fuller b, Erica Knavel Koepsel d, Brock Hewitt k, Mishal Mendiratta-Lala fDavid C.H. Kwon a, The first international experience with histotripsy: a safety analysis of 230 cases. Journal of Gastrointestinal Surgery
Volume 29, Issue 4, April 2025, 102000