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

Last updated: September 25, 2023
Sponsor: UMC Utrecht
Overall Status: Active - Recruiting

Phase

N/A

Condition

Bladder Cancer

Esophageal Cancer

Brain Cancer

Treatment

Radiation therapy

Clinical Study ID

NCT04075305
NL66650.041.18
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

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.

Study Design

Total Participants: 8000
Treatment Group(s): 1
Primary Treatment: Radiation therapy
Phase:
Study Start date:
February 01, 2019
Estimated Completion Date:
May 01, 2025

Study 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.

Connect with a study center

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

    Melbourne,
    Australia

    Site Not Available

  • Insitut Jules Bordet

    Brussel,
    Belgium

    Site Not Available

  • Sunnybrook Health Sciences Centre/Odette Cancer Centre

    Toronto, Ontario
    Canada

    Active - Recruiting

  • University Health Network - Princess Margaret Cancer Center

    Toronto,
    Canada

    Active - Recruiting

  • Odense Universitetshospital

    Odense, Funen 5000
    Denmark

    Active - Recruiting

  • Universitätsklinikum Tübingen

    Tübingen,
    Germany

    Active - Recruiting

  • Università degli Studi di Brescia

    Brescia,
    Italy

    Site Not Available

  • IRCCS Ospedale Sacro Cuore Don Calabria

    Negrar,
    Italy

    Active - Recruiting

  • Netherlands Cancer Institute, Antoni van Leeuwenhoek Hospital

    Amsterdam,
    Netherlands

    Active - Recruiting

  • Radiotherapiegroep

    Deventer,
    Netherlands

    Active - Recruiting

  • Radiotherapeutisch Instituut Friesland (RIF)

    Leeuwarden,
    Netherlands

    Site Not Available

  • Radboud UMC

    Nijmegen,
    Netherlands

    Active - Recruiting

  • University Medical Center Utrecht

    Utrecht, 3508GA
    Netherlands

    Active - Recruiting

  • The Royal Marsden and The Institute of Cancer Research National Institute for Health Research Biomedical Research Centre

    London,
    United Kingdom

    Active - Recruiting

  • The Christie National Health Service Foundation Trust

    Manchester,
    United Kingdom

    Active - Recruiting

  • Allegheny Health Network

    Pittsburgh, Pennsylvania 15212
    United States

    Active - Recruiting

  • Md Anderson Cancer Center

    Houston, Texas 77030
    United States

    Active - Recruiting

  • Medical College of Wisconsin

    Milwaukee, Wisconsin 53226
    United States

    Active - Recruiting

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