RadioVal, A new European project to clinically validate an artificial intelligence solution for breast cancer treatment planning

Posted on: 24 November 2022

RadioVal, coordinated by the University of Barcelona – Faculty of Mathematics & Computer Science is the first major multi-centre, multi-continental and multi-disciplinary project to clinically validate an artificial intelligence solution for the prediction of patient-specific response to neoadjuvant chemotherapy in breast cancer, in eight clinical centers across Europe, South America, North Africa and Eurasia.

With breast cancer becoming the most common cancer worldwide, it is paramount to improve treatment and care. New treatment protocols have shown promise in reducing mortality, such as neoadjuvant chemotherapy (NAC), but they face important challenges including variability in efficacy and important side effects for patients. RadioVal will validate an artificial intelligence (AI) solution which will support clinicians in selecting the patients that are most likely to respond to neoadjuvant chemotherapy, hence reducing unnecessary treatments and patient suffering due to side effects.

The AI solution built from radiological data, otherwise known as radiomics AI, will be validated in a variety of clinical centres across the world, including from three high-income EU countries (Sweden, Austria, Spain), two emerging EU countries (Poland, Croatia), and three countries from South America (Argentina), North Africa (Egypt) and Eurasia (Turkey). Furthermore, it will validate the AI technology for its accuracy, but also for technical robustness, clinical safety and utility, applicability in the real world, as well as ethical excellence and legal compliance.

This will be the very first international validation of a radiology AI solution in breast cancer with the aim to demonstrate that it can be trusted by clinicians, patients and other stakeholders, and hence it can be deployed and adopted by healthcare centres. The RadioVal study will be implemented through a multi-stakeholder approach, taking into account clinical and healthcare needs, as well as socio-ethical and regulatory requirements from day one to foster acceptance and adoption.

Karim Lekadir, Professor at the Faculty of Mathematics & Computer Science and RadioVal’s Project Coordinator declared: “RadioVal is an unprecedented opportunity to deliver strong evidence on the clinical utility and applicability of radiology AI for breast cancer care in the real world”.

The project started on the 1st of September 2022 and the kick-off meeting took place in Barcelona on 15-16 September 2022, with representatives of the RadioVal consortium, which consists of the following partners:

  1. University of Barcelona, Spain (Coordinators)
  2. Maastricht University, Netherlands
  3. Quibim S.L., Spain
  4. Foundation for Research and Technology, Greece
  5. Grupo Maggioli, Italy
  6. SHINE 2Europe, Portugal
  7. Nordic Healthcare Group, Finland
  8. La Fe University Hospital Valencia, Spain
  9. Karolinska Institutet, Sweden
  10. Medical University of Gdansk, Poland
  11. University of Zagreb School of Medicine, Croatia
  12. Medical University of Vienna, Austria
  13. Hacettepe University Hospital, Turkey
  14. Alexander Fleming Institute, Argentina
  15. Ain Shams University Hospital, Egypt
  16. European Institute for Biomedical Imaging Research, Austria

The project is co-funded under the Horizon Europe Programme through the HORIZON-HLTH-2021-DISEASE-04 call and received a 5.8 million€ funding.