The MOMENTUM Study: An International Registry for the Evidence-Based Introduction of MR-Guided Adaptive Therapy

Abstract

Purpose: MR-guided Radiation Therapy (MRgRT) allows for high-precision radiotherapy under real-time MR visualization. This enables margin reduction and subsequent dose escalation which may lead to higher tumor control and less toxicity. The Unity MR-linac (Elekta AB, Stockholm, Sweden) integrates a linear accelerator with a 1.5T diagnostic quality MRI and an online adaptive workflow. A prospective international registry was established to facilitate the evidence-based implementation of the Unity MR-linac into clinical practice, to systemically evaluate long-term outcomes, and to aid further technical development of MR-linac-based MRgRT. Methods and Results: In February 2019, the Multi-OutcoMe EvaluatioN of radiation Therapy Using the MR-linac study (MOMENTUM) started within the MRlinac Consortium. The MOMENTUM study is an international academic-industrial partnership between several hospitals and industry partner Elekta. All patients treated on the MR-linac are eligible for inclusion in MOMENTUM. For participants, we collect clinical patient data (e.g., patient, tumor, and treatment characteristics) and technical patient data which is defined as information generated on the MR-linac during treatment. The data are captured, pseudonymized, and stored in an international registry at set time intervals up to two years after treatment. Patients can choose to provide patient-reported outcomes and consent to additional MRI scans acquired on the MR-linac. This registry will serve as a data platform that supports multicenter research investigating the MR-linac. Rules and de Mol van Otterloo et al. The MOMENTUM Study regulations on data sharing, data access, and intellectual property rights are summarized in an academic-industrial collaboration agreement. Data access rules ensure secure data handling and research integrity for investigators and institutions. Separate data access rules exist for academic and industry partners. This study is registered at ClinicalTrials.gov with ID: NCT04075305 (https://clinicaltrials.gov/ct2/show/NCT04075305). Conclusion: The multi-institutional MOMENTUM study has been set up to collect clinical and technical patient data to advance technical development, and facilitate evidenced-based implementation of MR-linac technology with the ultimate purpose to improve tumor control, survival, and quality of life of patients with cancer.

MR-Guided Adaptive Radiotherapy for Bladder Cancer

“…Whether the closer integration of MRI into the bladder patient radiotherapy pathway translates into clinical gains for our patient population is still yet to be determined. A framework for clinical evaluation of MR-Linac technologies has been suggested (134,135). We would strongly advocate participation in clinical trials to generate robust evidence base to prove our expectations (and hopes) of further improving bladder cancer patient outcomes with MRgRT.…”

Initial Clinical Experience of MR-Guided Radiotherapy for Non-Small Cell Lung Cancer

“…It is a prospective, multi-institutional, international cohort study/registry investigating the implementation of the Unity MR-Linac and its ongoing development. All patients treated on the MR-linac are eligible for inclusion in MOMENTUM across 12 disease sites, including lung cancer ( 42 ). The objective of MOMENTUM is to collect and evaluate technical and clinical data to allow for optimisation of software with the ultimate aim of improving local disease control, patient survival, and quality of life.…”

MR-Guided Radiotherapy for Prostate Cancer

“…Future studies about MR-linac clinical feasibility and patient toxicity outcomes are currently underway such as the Prostate Radiotherapy Integrated with Simultaneous MRI (PRISM study, NCT03658525), and the MOMENTUM study [The Multiple Outcome Evaluation of Radiotherapy Therapy Using the MR-linac Study (NCT04075305)] ( 44 ), which will help develop faster, more efficient workflows and benchmark multi-center patient outcomes. The ongoing Magnetic Resonance Imaging-Guided Stereotactic Body Radiotherapy for Prostate Cancer trial (MIRAGE trial, NCT04384770) is a phase III randomized study comparing standard CT-guided SBRT versus MRI-guided SBRT, with the primary endpoint of acute grade ≥2 genitourinary (GU) toxicity.…”