2026-04-17T02:15:48Zhttps://recercat.cat/oai/request

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

00925njm 22002777a 4500 dc Wah, Tze Min author Thormann, Maximilian author Serres Créixams, Xavier author Littler, Peter author Stenberg, Benjamin author Pech, Maciej author 2023-02-21T11:13:55Z 2023-02-21T11:13:55Z 2023-02 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. http://hdl.handle.net/11351/9025 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 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)