Early adoption of image-guided histotripsy therapy in interventional oncology: challenges and opportunities in the United Kingdom.

Abstract

Histotripsy represents a paradigm shift in interventional oncology (IO) as the first non-invasive, non-ionizing and non-thermal ultrasound-based ablation technology available for cancer therapy. Compared with thermal ablation techniques, the advantages of histotripsy include tissue-selective ablation near critical structures, reduced collateral injury risk, and treatment which is unaffected by the heat sink phenomenon, ensuring predictable treatment margins. Ultrasound technology can be constrained by tissue attenuation depending on the depth of the target; however, the early phase feasibility and pivotal trial results have been promising for its application in liver cancers, with emerging translational trials in renal and pancreatic cancer. In the United Kingdom, 2 well-established IO sites have participated in the pivotal #HOPE4LIVER Trial that led to approval by the US Food and Drug Administration in liver tumours therapy in 2023 and obtained Medicines and Healthcare products Regulatory Agency Unmet Clinical Need Authorisation for treatment of liver tumours in United Kingdom (April 2025) via the Innovative Devises Access Pathway. The global-first feasibility in renal cancer (CAIN trial) was also led by the United Kingdom and completed in April 2024. This review provides an overview of histotripsy and highlights the clinical challenges in early National Health Service (NHS) adoption such as the learning curve for operators and teams, regulatory processes, and synthesis of health economic evidence required for wider NHS commissioning. The review will also discuss the future directions of histotripsy, including combination immunomodulatory therapies, highlighting the need for continual national collaboration for successful integration in the NHS. Successfully integrating this technology into the NHS hinges on a unified national effort to navigate the clinical, regulatory and economic hurdles, ensuring its benefits reach patients nationwide.