2026-04-17T20:44:45Zhttps://recercat.cat/oai/request

oai:recercat.cat:11351/90252025-10-24T10:21:48Zcom_2072_378070com_2072_378040col_2072_378092

A Multi-centre, Single Arm, Non-randomized, Prospective European Trial to Evaluate the Safety and Efficacy of the HistoSonics System in the Treatment of Primary and Metastatic Liver Cancers (#HOPE4LIVER) Wah, Tze Min Thormann, Maximilian Serres Créixams, Xavier Littler, Peter Stenberg, Benjamin Pech, Maciej Institut Català de la Salut [Wah TM] Department of Diagnostic and Interventional Radiology, Institute of Oncology, St. James’s University Hospital, Leeds Teaching Hospitals NHS Trust, UK. Leeds Institute of Medical Research (LIMR), University of Leeds, Leeds, UK. [Pech M] Department of Interventional Radiology, Universitä tsklinikum Magdeburg, Magdeburg, Germany. [Thormann M] Clinic for Radiology and Nuclear Medicine, University Hospital Magdeburg, Magdeburg, Germany. [Serres X] Institut de Diagnòstic per la Imatge (IDI), Vall d’Hebron Hospital Universitari, Barcelona, Spain. [Littler P, Stenberg B] Department of Interventional Radiology, Freeman Hospital, Newcastle Upon Tyne, UK Vall d'Hebron Barcelona Hospital Campus Fetge - Càncer - Tractament Ultrasonoteràpia DISEASES::Neoplasms::Neoplasms by Site::Digestive System Neoplasms::Liver Neoplasms Other subheadings::Other subheadings::/therapy ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT::Therapeutics::Hyperthermia, Induced::Diathermy::Ultrasonic Therapy::High-Intensity Focused Ultrasound Ablation ENFERMEDADES::neoplasias::neoplasias por localización::neoplasias del sistema digestivo::neoplasias hepáticas Otros calificadores::Otros calificadores::/terapia TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS::terapéutica::hipertermia inducida::diatermia::tratamiento con ultrasonidos::ablación por ultrasonidos centrados de alta intensidad Hepatocellular carcinoma; Histotripsy; Non-thermal ablation Carcinoma hepatocelular; Histotricia; Ablación no térmica Carcinoma hepatocel·lular; Histotrícia; Ablació no tèrmica Purpose Image-guided thermal ablation are established treatment options for non-surgical patients with primary and metastatic liver cancers. However, there are limitations with nonuniformity of cancer tissue destruction, heat sink effect and the risk of thermal ablative injury. The current non-thermal ablative techniques have high risk of local recurrence and are not widely adopted. Histotripsy is a treatment technology that destroys targeted tissue under ultrasound visualization via mechanical destruction through the precise application of acoustic cavitation and can offer the potential of non-invasive, non-thermal and non-ionizing radiation cancer treatment. The aim of this multi-centre non-randomized phase I/II trial is to assess the initial safety and efficacy of the prototype investigational ‘System’ in the treatment of primary and metastatic liver cancers. Methods/Design All non-surgical patients with primary/metastatic liver cancers having had previous liver directed therapy, radiation therapy or image-guided ablation may be offered image-guided Histotripsy as per trial protocol. The co-primary endpoints are technical success and procedural safety. Technical success is determined, at ≤ 36 h post procedure, by evaluating the histotripsy treatment size and coverage. The procedural safety is defined by procedure related major complications, defined as Common Terminology Criteria for Adverse Events (CTCAE version 5) grade 3 or higher toxicities, up to 30 days post procedure. This phase I/II trial has intended to recruit up to 45 patients to show safety and efficacy of image-guided histotripsy in liver cancers. This trial study is funded by HistoSonics. 2023-02-21T11:13:55Z 2023-02-21T11:13:55Z 2023-02 info:eu-repo/semantics/article info:eu-repo/semantics/publishedVersion Wah TM, Pech M, Thormann M, Serres X, Littler P, Stenberg B, et al. A Multi-centre, Single Arm, Non-randomized, Prospective European Trial to Evaluate the Safety and Efficacy of the HistoSonics System in the Treatment of Primary and Metastatic Liver Cancers (#HOPE4LIVER). Cardiovasc Intervent Radiol. 2023 Feb;46:259–67. 1432-086X https://hdl.handle.net/11351/9025 10.1007/s00270-022-03309-6 36380155 000884159600001 http://hdl.handle.net/11351/9025 eng CardioVascular and Interventional Radiology;46 https://doi.org/10.1007/s00270-022-03309-6 Attribution 4.0 International http://creativecommons.org/licenses/by/4.0/ info:eu-repo/semantics/openAccess application/pdf Springer Scientia