Prototype validation and exploratory first-in-human pilot of an implantable Electric Field Therapy device for recurrent glioblastoma: iterative clinical safety assessment (IDEAL 0/1 study)

Research question This project will deliver a world-first clinical study of a novel implantable medical device for the treatment of recurrent glioblastoma using electrical fields. Background Electrical field therapy (EFT) an emerging treatment modality that has shown significant promise in the treatment of malignant brain tumours. The therapy works by interfering with cancer cell mitosis, pushing the cells into apoptotic cell death without harming the healthy non-mitotic brain tissue. There is one existing product, an external-to-the-body device, and it has a UKCA Mark. Clinical studies examining the product in combination with standard of care have demonstrated an increase in average 5-year survival of glioblastoma from <5% to 13%. However, using the product is difficult, expensive, limiting efficacy and impacting patient quality of life. Hence, EFT is not currently recommended by NICE despite a clear unmet clinical need for more effective therapies for glioblastoma in the UK. UK company QV Bioelectronics are developing a novel implantable medical device designed to overcome the shortcomings of the existing product and significantly improve the efficacy and usability. In this project QV are working with consultant neurosurgeons Prof Paul Brennan (Edinburgh) and Prof Stephen Price (Cambridge) to test the clinical feasibility of this novel device in patients with terminal recurrent glioblastoma for the first time. Aims and Objectives Objective 1: Complete design validation of QV s implantable medical device and receive approval from MHRA to proceed with a human clinical study in the UK. Objective 2: Assess the clinical feasibility of using QV s implantable device in up to two UK patients with recurrent glioblastoma. Primary endpoints in the study relate to safety (do no worse). Exploratory endpoints will also look for early signs of efficacy of the treatment. Methods The clinical study will be conducted in a stage-gated manner according to the IDEAL collaboration guidelines for best practice in surgical clinical trials. QV Bioelectronics operate an ISO13485 quality management system for the development of medical devices and applicable regulatory standards will be strictly followed. PPIE workshops, conducted with patient groups, will inform design of the study, ensuring acceptability of the protocol. This will beneficially impact study recruitment. Timelines for delivery The project will commence in January 2026 and run until the end of March 2028 (27 months). Regulatory approval to proceed will be sought by June 2027 and the first patient will be recruited into the study in July 2027. Anticipated Impact and Dissemination Clinical data from the stage 1 study will be published in peer-reviewed journals regardless of outcome. If successful, this study will be continued into a stage 2a clinical study of 15-20 patients total. The intention would be to expand the study to include further NHS centres of excellence and overseas clinical sites. QV Bioelectronics intend to use the pilot clinical data to raise further private capital to fund this study. An international multicentre pivotal study of ~200 patients examining efficacy would follow. Ultimately the intention is to develop a significantly improved cost-effective EFT device, improving patient outcomes for UK brain tumour patients.