The MOMENTUM study, an international registry of patients treated on an MR-linac: 9-month experience

Abstract

Purpose or Objective On February first 2019, the Multi-OutcoMe EvaluatioN of radiation Therapy Using the MR-linac study (MOMENTUM) opened for accrual. MOMENTUM is a prospective, international registry which facilitates technical development, clinical evaluation and evidence-based implementation of MRI guided Radiotherapy using the Unity MR-linac (Elekta AB). The MR-linac integrates a linear accelerator with a 1.5T diagnostic quality MRI and an online adaptive workflow. Here we present our 9-month experience of the MOMENTUM study. Material and Methods MOMENTUM study is an international academic-industrialpartnership between seven hospitals and industry partner Elekta (Elekta AB, Stockholm, Sweden). After initiation of the study, all patients treated with the MR-linac were eligible for inclusion. Pseudonymized clinical and technical patient data are captured at set time intervals until 24 months after treatment with the MR-linac. Clinical data, stored in an Openclinica database, include demographics, tumor characteristics, treatment details, toxicity, disease recurrence and survival data. Technical data, i.e. all the data generated and used by the machine before, during and after treatment is stored on a cloud-based platform. All participants in MOMENTUM provide informed consent for use of their data by the academic consortium partners and for data sharing with the industry partner except for Dutch patients. In The Netherlands patients can choose whether they want to share their data with the industry partner. Furthermore, all participants are asked to provide additional consent for collection of patient reported outcomes (PRO) and additional MRI scans on the MRlinac. Results Between February and October 2019, the study opened in all seven institutes, and until now, 200 patients have provided informed consent for participation in MOMENTUM. At time of writing, we accrued 127 patients with known information on tumor location with a median age of 66 years. 71% (n=90) of 127 patients were male. Most patients were treated for oligometastases (N=42), rectal cancer (N=21), or prostate cancer (N=12) (Figure 1). 95 patients had complete treatment data with a mean number of fraction per patients of four to 33. For 199 participants, preferences regarding additional data collection and data sharing with the industry were known. 197 (99%) of 199 participants shared data with industry partner Elekta, 80% (N=159) of participants consented to additional research MRIs, and 67% (N=133) of participants chose to collect additional PROs Conclusion The MOMENTUM study, an international multi-institutional registry, opened successfully at several sites and accrued 200 patients treated with the Unity MR-linac. Participants were treated with a mean number of fraction of four to 33 per patient. MOMENTUM contributes to optimal collection and usage of data of patients enabling the evidence-based implementation of the MR-linac.