The project encompasses several components: a Randomized Controlled Trial (RCT), a registry study, a cost-effectiveness analysis, and a pain education initiative. Ethical approvals for both the trial and registry have been successfully obtained across all partner institutions.
Significant progress has been made in the FURTHER trial. Preliminary data has been generated, a database established, and all trial-related and patient questionnaires developed and translated. Additionally, a technical expert visited partner institutions to optimize the MR-HIFU workflow, addressing local logistics and refining procedural approaches. Trial monitors conducted initiation visits—either in person or virtually—at all clinical partner institutions.
The impact of COVID-19 caused considerable delays in patient enrollment. By December 31, 2022, only 22 patients had been enrolled over three years, reflecting a much lower accrual rate than initially anticipated. To address this, several measures were implemented to boost recruitment, and by December 2024, 68 patients had been enrolled.
A detailed analysis of the radiotherapy-referred patient population's eligibility for MR-HIFU revealed that only 8% of patients with painful bone metastases referred for radiotherapy met the eligibility criteria for MR-HIFU. These findings were presented at multiple conferences and accepted for publication. Furthermore, the consortium investigated the variability in eligibility assessments among radiologists and radiation oncologists. Substantial variation was identified, prompting a consortium-led expert session to develop consensus guidelines on eligibility criteria.
The cost-effectiveness studies have been completed, including a literature review, identification of observer groups, and determination of parameters for cost analyses. Costing models for MR-HIFU and radiotherapy treatments were constructed, culminating in a publication detailing MR-HIFU costs from a hospital perspective in the German context.
To address practical barriers, a pan-European survey was conducted with clinical and patient stakeholders to identify obstacles to deploying anesthetic services for MR-HIFU treatment. This survey informed the development of an integrated pain management pathway, supported by evidence synthesis. Another European survey, employing Group Concept Mapping, identified barriers to the adoption of MR-HIFU for treating painful bone metastases. Over 40 participants contributed to the brainstorming and sorting phases of this process.
The project also achieved key communication milestones, including the launch of a dedicated project website and the finalization of a comprehensive communication plan. Numerous abstracts, presentations, and manuscripts were published, covering Pre-FURTHER trial results, trial design, and the health economic aspects of MR-HIFU.
The annual consortium meeting was held in Turku in 2024, where recruitment challenges and overall project progress were discussed. As part of these meetings, the consortium invited a representative from the European Association for Palliative Care to conduct an interactive session on strategies for boosting trial enrollment in palliative care patients. A consensus session on MR-HIFU eligibility criteria, leveraging the expertise of consortium members, was also conducted.
