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Brief Title: The MOMENTUM Study: The Multiple Outcome Evaluation of Radiation Therapy Using the MR-Linac Study
Official Title: The Multiple Outcome Evaluation of Radiation Therapy Using the MR-Linac Study
Study ID: NCT04075305
Brief 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Allegheny Health Network, Pittsburgh, Pennsylvania, United States
Md Anderson Cancer Center, Houston, Texas, United States
Medical College of Wisconsin, Milwaukee, Wisconsin, United States
Austin Health - Olivia Newton-John Cancer Wellness and Research Centre, Melbourne, , Australia
Insitut Jules Bordet, Brussel, , Belgium
Sunnybrook Health Sciences Centre/Odette Cancer Centre, Toronto, Ontario, Canada
University Health Network - Princess Margaret Cancer Center, Toronto, , Canada
Odense Universitetshospital, Odense, Funen, Denmark
Universitätsklinikum Tübingen, Tübingen, , Germany
Università degli Studi di Brescia, Brescia, , Italy
IRCCS Ospedale Sacro Cuore Don Calabria, Negrar, , Italy
Netherlands Cancer Institute, Antoni van Leeuwenhoek Hospital, Amsterdam, , Netherlands
Radiotherapiegroep, Deventer, , Netherlands
Radiotherapeutisch Instituut Friesland (RIF), Leeuwarden, , Netherlands
Radboud UMC, Nijmegen, , Netherlands
University Medical Center Utrecht, Utrecht, , Netherlands
The Royal Marsden and The Institute of Cancer Research National Institute for Health Research Biomedical Research Centre, London, , United Kingdom
The Christie National Health Service Foundation Trust, Manchester, , United Kingdom
Name: Helena M Verkooijen, Prof, Dr
Affiliation: Universitair Medical Centre Utrecht
Role: PRINCIPAL_INVESTIGATOR