Evidence map›Paper›PMID 39225612›Full record

ArticleRadiology2024

The #HOPE4LIVER Single-Arm Pivotal Trial for Histotripsy of Primary and Metastatic Liver Tumors.

Mishal Mendiratta-Lala, Philipp Wiggermann, Maciej Pech, Xavier Serres-Créixams, Sarah B White, Clifford Davis, Osman Ahmed, Neehar D Parikh, Mathis Planert, Maximilian Thormann and 9 more

2 registry-linked trialsAbstract readMulticenter Study
In one paragraph

Article in Radiology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 69 papers.

0numbers the graph read from it
0cells of the map it votes in
69citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04572633 naactive not recruitingnot on this map

The HistoSonics System for Treatment of Primary and Metastatic Liver Tumors Using Histotripsy (#HOPE4LIVER US)

TypeinterventionalSponsorHistoSonics, Inc.Ran2021 to 2027Enrolled47ConditionsLiver Neoplasms, Hepatocellular Carcinoma, Liver MetastasesArmsHistoSonics System
NCT04573881 naactive not recruitingnot on this map

The HistoSonics System for Treatment of Primary and Metastatic Liver Tumors Using Histotripsy (#HOPE4LIVER EU/UK)

TypeinterventionalSponsorHistoSonics, Inc.Ran2021 to 2027Enrolled24ConditionsLiver Neoplasms, Hepatocellular Carcinoma, Liver MetastasesArmsHistoSonics System
3 · Its place in the literature

Who cites it

69 citing papers in PubMed.

  1. Article
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  4. Histotripsy for Liver Tumors: Breakthrough or Hype?Annals of surgical oncology · 2026
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9 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

19 authors.

Mishal Mendiratta-LalaFrom 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.).ORCID 0000-0003-4055-916X
Philipp WiggermannFrom 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.).ORCID 0000-0003-4424-7489
Maciej PechFrom 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.).ORCID 0000-0002-7140-6775
Xavier Serres-CréixamsFrom 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.).
Sarah B WhiteFrom 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.).ORCID 0000-0002-6870-6400
Clifford DavisFrom 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.).
Osman AhmedFrom 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.).ORCID 0000-0003-2440-2437
Neehar D ParikhFrom 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.).ORCID 0000-0002-5874-9933
Mathis PlanertFrom 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.).ORCID 0000-0003-1419-1891
Maximilian ThormannFrom 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.).ORCID 0000-0003-3822-8871
Zhen XuFrom 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.).
Zachary CollinsFrom 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.).ORCID 0000-0003-2641-7990
Govindarajan NarayananFrom 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.).
Guido TorzilliFrom 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.).
Clifford ChoFrom 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.).ORCID 0000-0002-9577-7626
Peter LittlerFrom 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.).ORCID 0009-0006-3529-4303
Tze Min WahFrom 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.).ORCID 0000-0001-5670-5454
Luigi Solbiati *From 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.).ORCID 0000-0002-3109-1449
Timothy J Ziemlewicz *From 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.).ORCID 0000-0002-7033-1062

Funding

Developing Methods for Precise, Safe and Target-location Specific Histotripsy of Liver TumorsR01CA262474 · NCI · UNIVERSITY OF WISCONSIN-MADISON · PI ZIEMLEWICZ, TIMOTHY J · 2021 to 2025
$2.4M
NCI NIH HHS R01 CA262474
6 · The paper itself

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.

Indexed as

Liver NeoplasmsAgedEuropeFemaleHigh-Intensity Focused Ultrasound AblationHumansLiverMagnetic Resonance ImagingMaleMiddle AgedProspective StudiesTomography, X-Ray ComputedTreatment OutcomeUnited States

Identifiers

PMID39225612
PMCPMC11427859

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