Related Experiment Video
Updated: May 10, 2026
Treatment of Liver Metastases Using an Internal Target Volume Method for Stereotactic Body Radiotherapy
Published on: May 8, 2018
The #HOPE4LIVER Single-Arm Pivotal Trial for Histotripsy of Primary and Metastatic Liver Tumors
Mishal Mendiratta-Lala1, Philipp Wiggermann1, Maciej Pech1
1From the Department of Radiology, University of Michigan Medicine, Ann Arbor, Mich (M.M.L., N.D.P., C.C.); Institut für Röntgendiagnostik und Nuklearmedizin, Städtisches Klinikum Braunschweig, Braunschweig, Germany (P.W., M.P.); Klinik für Radiologie und Nuklearmedizin, Universitätsklinikum Magdeburg, Magdeburg, Germany (M.P., M.T.); Department of Radiology, Vall d'Hebrón University Hospital, Barcelona, Spain (X.S.C.); Department of Radiology, Medical College of Wisconsin, Milwaukee, Wis (S.B.W.); Department of Radiology, Tampa General Hospital, Tampa, Fla (C.D.); Department of Interventional Radiology, University of Chicago Pritzker School of Medicine, Chicago, Ill (O.A.); Departments of Biomedical Engineering, Radiology, and Neurosurgery, University of Michigan, Ann Arbor, Mich (Z.X.); Department of Radiology, University of Kansas Medical Center, Kansas City, Kan (Z.C.); Department of Interventional Radiology, Baptist Hospital of Miami, Miami, Fla (G.N.); Department of Biomedical Science, Humanitas University & Humanitas Clinical and Research Hospital IRCCS, Rozzano, Italy (G.T., L.S.); Department of Radiology, Freeman Hospital, Newcastle, United Kingdom (P.L.); Department of Diagnostic and Interventional Radiology, Leeds Teaching Hospital and Trust, West Yorkshire, United Kingdom (T.M.W.); and Department of Radiology, University of Wisconsin School of Medicine and Public Health, 600 Highland Ave, Madison, WI 53792 (T.J.Z.).
Abstract:
Background Histotripsy is a nonthermal, nonionizing, noninvasive, focused US technique that relies on cavitation for mechanical tissue breakdown at the focal point. Preclinical data have shown its safety and technical success in the ablation of liver tumors. Purpose To evaluate the safety and technical success of histotripsy in destroying primary or metastatic liver tumors. Materials and Methods The parallel United States and European Union and England #HOPE4LIVER trials were prospective, multicenter, single-arm studies. Eligible patients were recruited at 14 sites in Europe and the United States from January 2021 to July 2022. Up to three tumors smaller than 3 cm in size could be treated. CT or MRI and clinic visits were performed at 1 week or less preprocedure, at index-procedure, 36 hours or less postprocedure, and 30 days postprocedure. There were co-primary end points of technical success of tumor treatment and absence of procedure-related major complications within 30 days, with performance goals of greater than 70% and less than 25%, respectively. A two-sided 95% Wilson score CI was derived for each end point. Results Forty-four participants (21 from the United States, 23 from the European Union or England; 22 female participants, 22 male participants; mean age, 64 years ± 12 [SD]) with 49 tumors were enrolled and treated. Eighteen participants (41%) had hepatocellular carcinoma and 26 (59%) had non-hepatocellular carcinoma liver metastases. The maximum pretreatment tumor diameter was 1.5 cm ± 0.6 and the maximum post-histotripsy treatment zone diameter was 3.6 cm ± 1.4. Technical success was observed in 42 of 44 treated tumors (95%; 95% CI: 84, 100) and procedure-related major complications were reported in three of 44 participants (7%; 95% CI: 2, 18), both meeting the performance goal. Conclusion The #HOPE4LIVER trials met the co-primary end-point performance goals for technical success and the absence of procedure-related major complications, supporting early clinical adoption. Clinical trial registration nos. NCT04572633, NCT04573881 Published under a CC BY 4.0 license. Supplemental material is available for this article. See also the editorial by Nezami and Georgiades in this issue.
