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EU funded RadioVal research project aims to clinically validate radiomics-driven estimation of NAC response in breast cancer

The four-year research project started in September 2022 and is funded by the European Union under Grant Agreement No. 101057699. The RadioVal project will develop a comprehensive and standardised methodological framework for multi-faceted radiomics evaluation based on the FUTURE-AI Guidelines. The project consortium is led by Universitat De Barcelona, and the consortium includes universities, as well as clinical and research partners around Europe and worldwide. Nordic Healthcare Group (NHG) is responsible for evaluating the impact of the developed solution.

Breast cancer is now the most common cancer worldwide, surpassing lung cancer in 2020 for the first time. It is responsible for almost 30% of all cancers in women and current trends show its increasing incidence.

Neoadjuvant chemotherapy (NAC) has shown promise in reducing mortality for advanced cases, but the therapy is associated with a high rate of over-treatment, as well as significant side effects for the patients. For predicting NAC respondents and improving patient selection, artificial intelligence (AI) approaches based on radiomics have shown promising preclinical evidence, but existing studies have mostly focused on evaluating model accuracy, all too often in homogeneous populations.

RadioVal is the first multi-centre, multi-continental, and multi-faceted clinical validation of radiomics-driven estimation of NAC response in breast cancer. The project builds on the repositories, tools, and results of five EU-funded projects from the AI for Health Imaging (AI4HI) Network, including a large multi-centre cancer imaging dataset on NAC treatment in breast cancer.

To test applicability as well as transferability, the validation which take place in eight clinical centres 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).

RadioVal will develop a comprehensive and standardised methodological framework for multi-faceted radiomics evaluation based on the FUTURE-AI Guidelines, to assess Fairness, Universality, Traceability, Usability, Robustness, and Explainability. Furthermore, the project will introduce new tools to enable transparent and continuous evaluation and monitoring of the radiomics tools over time. 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.

The project consortium is led by Universitat De Barcelona and other partners include Universiteit Maastricht, Quibim Sociedad Limitada, Idryma Technologias Kai Erevnas, Maggioli Spa, Shine 2europe Lda, NHG Finland Oy, Fundacion Para La Investigacion Del Hospital Universitario La Fe Dela Comunidad Valenciana, Karolinsk  Institutet, Gdanski Uniwersytet Medyczny, Sveuciliste U Zagrebu  Medicinski  Fakultet, Medizinische Universität Wien, Hacettepe Universitesi, Alexander Fleming SA, Ain Shams University, and Eibir Gemeinnutzige GmbH zur Forderung der Erforschung Derbiomedizinischen Bildgebung.

Kick off in Barcelona