NCT04075305

The MOMENTUM Study: The Multiple Outcome Evaluation of Radiation Therapy Using the MR-Linac Study

The Multiple Outcome Evaluation of Radiation Therapy Using the MR-Linac Study

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 8,000 (estimated)
• Sponsor: UMC Utrecht · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The Multi-OutcoMe EvaluatioN of radiation Therapy Using the Unity MR-Linac Study (MOMENTUM) is a multi-institutional, international registry facilitating evidenced based implementation of the Unity MR-Linac technology and further technical development of the MR-Linac system with the ultimate purpose to improve patients' survival, local, and regional tumor control and quality of life.

Detailed description

Rationale: Radiation therapy has become indispensable in cancer treatment. However, it is associated with severe side effects. Innovation in radiation therapy has resulted in the development of MR-guided radiation therapy (MRGRT) which allows high precision radiotherapy under real time MR visualization. High precision MRGRT has the potential of dose escalation and margin reduction and may potentially lead to higher cure rates and less toxicity. MRGRT can be delivered by the MRI guided Linear Accelerator (MR-Linac) which integrates a state-of-the-art linear accelerator, 1.5T diagnostic quality MRI and an online adaptive workflow. Objective: The Multi-OutcoMe EvaluatioN of radiation Therapy Using the MR-Linac Study (MOMENTUM) aims to accelerate the technical and clinical development of Anatomic and Biologic MRGRT and facilitate the evidence-based introduction of the MR-Linac into clinical practice. In MOMENTUM, technical and clinical data are gathered in order to optimize software, evaluate treatment outcomes, toxicities and progression free, disease free, and overall survival per disease site, and create a repository of anatomical and biological MR sequences to develop new features. Study design: A multi-institutional, international observational cohort study. Study population: Cancer patients ≥ 18 years receiving treatment and/or imaging on an MR-Linac machine are eligible for enrollment. Main study parameters/endpoints: MOMENTUM will collect technical and clinical patient data. The technical patient data is defined as data generated by (the use of) the MR-Linac and will include data collection during scans performed during routine care as well as research MRIs. Clinical data will be categorized into six classes: demographic, disease characteristics, treatment classifiers, toxicity outcomes, cancer control outcomes and PROs.

Conditions

• Oncology
• Breast Cancer
• Prostate Cancer
• Gynecologic Cancer
• Brain Tumor
• Brain Cancer
• Gynecologic Tumor
• Prostate Tumor
• Prostate Neoplasm
• Breast Tumor
• Radiation Toxicity
• Quality of Life
• Rectal Cancer
• Rectal Tumor
• Rectal Neoplasms
• Lung Cancer
• Lung Tumor
• Lung Neoplasm
• Esophageal Cancer
• Esophagus Cancer
• Esophageal Tumor
• Esophageal Neoplasm
• Esophagus Tumor
• Esophagus Neoplasm
• Pancreatic Cancer
• Pancreatic Tumor
• Pancreatic Neoplasms
• Head and Neck Cancer
• Head and Neck Neoplasms
• Head and Neck Tumor
• Tumor
• Neoplasms
• Bladder Cancer
• Bladder Neoplasm
• Liver Cancer
• Liver Neoplasms
• Liver Metastases
• Oligometastases

Interventions

Type	Name	Description
RADIATION	Radiation therapy	Radiation therapy on the CE marked and FDA approved MR-Linac

Timeline

• Start date: 2019-02-01
• Primary completion: 2030-02-01
• Completion: 2030-08-01
• First posted: 2019-08-30
• Last updated: 2026-03-05

Locations

18 sites across 9 countries: United States, Australia, Belgium, Canada, Denmark, Germany, Italy, Netherlands, United Kingdom

Regulatory

• FDA-regulated device study