Back to Trials
NCT04075305Recruiting

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

UMC Utrecht

Start Date

2/1/2019

Completion Date

8/1/2030

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.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * Patient is to undergo or has completed imaging or treatment procedures on an MR-Linac; * Patient provides written, informed consent; * Patient is 18 years old or older. Exclusion Criteria: * MRI exclusion criteria, including * MRI contraindications as per usual clinical care, such as (possible) pregnancy; claustrophobia and metal or electronic implants not compatible with MRI.

Interventions

RADIATION

Radiation therapy

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

OncologyBreast CancerProstate CancerGynecologic CancerBrain TumorBrain CancerGynecologic TumorProstate TumorProstate NeoplasmBreast TumorRadiation ToxicityQuality of LifeRectal CancerRectal TumorRectal NeoplasmsLung CancerLung TumorLung NeoplasmEsophageal CancerEsophagus CancerEsophageal TumorEsophageal NeoplasmEsophagus TumorEsophagus NeoplasmPancreatic CancerPancreatic TumorPancreatic NeoplasmsHead and Neck CancerHead and Neck NeoplasmsHead and Neck TumorTumorNeoplasmsBladder CancerBladder NeoplasmLiver CancerLiver NeoplasmsLiver MetastasesOligometastases

Locations

Allegheny Health Network

Pittsburgh, Pennsylvania 15212

United States

Md Anderson Cancer Center

Houston, Texas 77030

United States

Medical College of Wisconsin

Milwaukee, Wisconsin 53226

United States

Austin Health - Olivia Newton-John Cancer Wellness and Research Centre

Melbourne,

Australia

Insitut Jules Bordet

Brussels,

Belgium

Sunnybrook Health Sciences Centre/Odette Cancer Centre

Toronto, Ontario

Canada

University Health Network - Princess Margaret Cancer Center

Toronto,

Canada

Odense Universitetshospital

Odense, Funen 5000

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, 3508GA

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