From pre-clinical studies to human treatment with proton-minibeam radiation therapy: adapted Idea, Development, Exploration, Assessment and Long-term evaluation (IDEAL) framework for innovation in radiotherapy.

The implementation and spread of new radiation therapy (RT) techniques are often rushed through before or without high-quality proof of a clinical benefit. The framework for phase 1, 2 and 3 trials, ideally designed for pharmaceutical evaluation, is not always appropriate for RT interventions. The IDEAL framework is a five-step process initially developed to enable the rapid implementation of surgical innovations while limiting risks for patients. IDEAL was subsequently adapted to RT. Proton-minibeam radiation therapy (pMBRT) is an innovative RT approach, using an array of parallel thin beams resulting in an outstanding increase in the therapeutic ratio. Cumulative preclinical evidence showed pMBRT was superior to standard RT regarding brain tolerance and provided equivalent or better local control in several glioblastoma models. We decided to adapt IDEAL to pMBRT to accelerate the implementation of this promising new technique in clinical care and present here some examples of possible upcoming studies.