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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)

Lookup NU author(s): Dr Peter Littler

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This work is licensed under a Creative Commons Attribution 4.0 International License (CC BY 4.0).


Abstract

© 2022, The Author(s).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. Trail Registration: Clinicaltrials.gov identifier-NCT04573881; NIHR CRN CPMS-ID 47572.


Publication metadata

Author(s): Wah TM, Pech M, Thormann M, Serres X, Littler P, Stenberg B, Lenton J, Smith J, Wiggermann P, Planert M, Vidal-Jove J, Torzilli G, Solbiati L

Publication type: Article

Publication status: Published

Journal: CardioVascular and Interventional Radiology

Year: 2022

Pages: epub ahead of print

Online publication date: 15/11/2022

Acceptance date: 20/10/2022

Date deposited: 29/11/2022

ISSN (print): 0174-1551

ISSN (electronic): 1432-086X

Publisher: Springer

URL: https://doi.org/10.1007/s00270-022-03309-6

DOI: 10.1007/s00270-022-03309-6


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Funding

Funder referenceFunder name
HistoSonics

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