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.

in Clinical and translational radiation oncology by Emmanuel Jouglar, Ludovic de Marzi, Pierre Verrelle, Gilles Créhange, Regis Ferrand, François Doz, Yolanda Prezado, Xavier Paoletti

TLDR

  • A study aims to accelerate the implementation of proton-minibeam radiation therapy (pMBRT) in clinical care using the IDEAL framework, demonstrating its effectiveness and safety in glioblastoma treatment.
  • Cumulative preclinical evidence shows that pMBRT is superior to standard RT regarding brain tolerance and local control in glioblastoma models.
  • The study's findings have significant implications for the treatment of glioblastoma and may pave the way for the rapid implementation of other innovative RT techniques.

Abstract

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.

Overview

  • The study focuses on the implementation of new radiation therapy (RT) techniques, specifically proton-minibeam radiation therapy (pMBRT), and its proof of clinical benefit.
  • The IDEAL framework, initially designed for pharmaceutical evaluation, was adapted to RT to accelerate the implementation of pMBRT in clinical care.
  • The study aims to demonstrate the effectiveness and safety of pMBRT in glioblastoma treatment and accelerate its implementation in clinical practice.

Comparative Analysis & Findings

  • Cumulative preclinical evidence shows that pMBRT is superior to standard RT regarding brain tolerance and provides equivalent or better local control in several glioblastoma models.
  • The IDEAL framework, when adapted to RT, enables the rapid implementation of pMBRT while limiting risks for patients.
  • The study aims to accelerate the implementation of pMBRT in clinical care by designing phase 1, 2, and 3 trials using the IDEAL framework.

Implications and Future Directions

  • The study's findings have significant implications for the treatment of glioblastoma, as pMBRT may offer improved outcomes for patients.
  • Future studies should investigate the long-term effects of pMBRT and compare its outcomes with those of other RT modalities.
  • The adaptation of the IDEAL framework to RT may pave the way for the rapid implementation of other innovative RT techniques, improving patient care.
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