Barcelona, September 26, 2023 — The EU-funded RadioVal project, dedicated to raising the standard of breast cancer care through the use of artificial intelligence-based prediction, enters its second year. This milestone allows us to reflect on the remarkable achievements of the past year and share our ambitious plans for the upcoming year.
Nordic Healthcare Group (NHG) is responsible for evaluating the impact of the developed solution. NHG as a European expert on value-based care, cost-effectiveness analysis and regulatory aspects of emerging health solutions will in RadioVal prepare for radiomics qualification and classification as a medical device and assess the cost-effectiveness of the RadioVal solution.
Year One Achievements:
In its first year, RadioVal accomplished noteworthy milestones and undertakings that will serve as a solid foundation for the project’s future years. This includes:
Radiomics AI Passport:
We made substantial progress in designing an AI passport, a traceability tool to monitor radiomic tools transparently over their lifespan. The AI passport framework and technical design are well-established, with the development of the first prototype and user interface set for the coming year.
Radiomics Evaluation Criteria and Procedures:
RadioVal partners have identified criteria and metrics for comprehensive radiomics AI evaluation in breast cancer. This includes integration with the AI passport and human-in-the-loop mechanisms. We have also conducted explorative analyses of open-access datasets to enhance project capabilities.
Clinical Data Compilation:
The compilation of clinical, patient, and healthcare requirements is underway. We have created the RadioVal dataset, a dedicated clinical database, and a user manual to standardize data collection and methodology during the project.
Social Innovation and Stakeholder Engagement:
In RadioVal, social innovation is used to identify new approaches for multi-stakeholder, inclusive and trusted validation, and implementation of radiomics solutions in tomorrow’s clinical oncology. In its first year, RadioVal designed a social innovation framework, including stakeholder mapping, a toolkit and methodology. However, this is only the beginning as the social innovation activities will last the entire project, in a highly iterative and interactive approach and until now already included 86 participants in different online and face-to-face co-creation sessions and interviews.
Clinical Study Documentation and Ethics Approvals:
RadioVal diligently prepared the groundwork for clinical studies in the upcoming year. Our consortium ensured ethical and regulatory compliance, adhering to Good Clinical Practice and GDPR regulations across participating clinical centers. Furthermore, RadioVal registered as a Clinical Trial Study, obtaining the protocol ID: RADIOVAL NCT05070884.
Year Two Outlook:
As we embark on our second year, RadioVal is excited to announce our immedate objectives for the coming year:
In the next few months, a working group will plan the implementation of an international study for in-depth, multi-faceted evaluation of the radiomics tools for treatment planning in breast cancer based on the criteria, metrics and procedures defined by the RadioVal Consortium. We will specifically evaluate the robustness, fairness, usability, explainability, traceability and scalability of the radiomics models. Then we plan comparisons of the results between internal and external sites, as well as across international countries.
Consensus on RadioVal Tool Requirements
Achieving consensus on multidisciplinary requirements is our focus, covering clinical, patient, healthcare, socio-ethical, legal, and regulatory aspects. Stakeholder sessions and Delphis will drive agreement and advance us toward the validation study.
Evaluation Criteria and Metrics:
Developing evaluation metrics for Radiomics-based models and AI models in healthcare and medical imaging is a priority. We have established a working group, which will finalize these metrics and publish a scientific paper outlining their practical application.
We are focusing on the development of models for automated breast tumour segmentation, validating breast cancer treatment prediction and survival models, and enhancing model trust through FUTURE-AI recommendations.
With these upcoming activities, we will demonstrate further innovation in breast cancer treatment prediction and pave the way to delivering personalised treatment to patients worldwide.
“In our first year of collaboration, we have achieved significant progress and made pivotal decisions for RadioVal. Looking ahead, we are enthusiastic about creating cutting-edge AI-powered tools that can revolutionize breast cancer treatment predictions and bolster clinical confidence.” – Oliver Diaz, Coordinator of RadioVal.
RadioVal is an EU-funded project that aims to validate an AI solution for breast cancer treatment planning. We are the first major multi-centre, multi-continental and multi-disciplinary project to clinically validate an AI solution for the prediction of patient-specific response to neoadjuvant chemotherapy in breast cancer. The project began on September 1, 2023, and is scheduled to conclude on August 31, 2026, under the leadership of the University of Barcelona.
For further details, please visit https://radioval.eu/.
This project has received funding from the European Union’s Horizon Europe research and innovation programme under grant agreement No 101057699. Views and opinions expressed are however those of the author(s) only and do not necessarily reflect those of the European Union. Neither the European Union nor the granting authority can be held responsible for them.