Evolution of the MOMENTUM Study for Evidence-Based Implementation of MR-Guided Radiotherapy Using the 1.5 Tesla MR-Linac

Abstract

PURPOSE/OBJECTIVE(S): The international prospective 'Multiple Outcome Evaluation of Radiation Therapy Using the MR-Linac' (MOMENTUM) study (NCT04075305) was initiated in 2019 by seven hospitals and industry partner precision radiation medicine company, with the aim to facilitate evidence-based implementation of magnetic resonance (MR) guided radiotherapy using the 1.5 Tesla (T) MR-linear accelerator (Linac). Over the last four years, MOMENTUM has expanded to other institutions and the design and organization of MOMENTUM have evolved. Herein, we give an overview of the current status of MOMENTUM and study innovations that have been implemented to accelerate development and assessment of the 1.5T MR-Linac. MATERIALS/METHODS: We summarized operational outputs of MOMENTUM, including site participation, data aggregation, academic output, and study design elements that have been introduced since 2019. RESULTS: As of January 2023, 17 sites have joined and 10 sites are actively enrolling patients in MOMENTUM. The MOMENTUM infrastructure, which consists of prospectively collected clinical and technical patient data and patient reported outcomes, is increasingly being used for predicate studies, technical development studies, safety and early clinical evaluation, and hypothesis testing studies according to R-IDEAL. Over 3500 patients who received treatment for 33 different tumor sites have provided informed consent for using their data for scientific research and product development. The technical database currently includes over 190.000 items, including approximately 98,000 MRI scans and 33,800 dose plans. A total of 38 data requests have been accepted (2019: n = 1; 2020: n = 5; 2021: n = 10; 2022: n = 22), including technical studies focused on algorithmic development. The MOMENTUM infrastructure is also hosting prospective clinical studies, including the randomized HERMES trial (NCT04595019) and prospective UNITED study (NCT04726397). Recently, the 'Trials within Cohorts' (TwiCs) design has been implemented, which is well suited to perform pragmatic randomized trials. MOMENTUM has partnered with Kaiku Health, an electronic patient-reported outcomes application, to facilitate collection of patient reported toxicity. CONCLUSION: Over the past four years, the MOMENTUM study has evolved into a unique platform, whose infrastructure is increasingly being used by clinicians, researchers, physicists and industry. Continuous efforts are being made to encourage the participation of new sites and the development of innovative tools to facilitate the conduct of well-designed trials that are expected to transform daily clinical practice.