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Recruiting NCT04075305

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

— Observational Oncology Breast Cancer Prostate Cancer Gynecologic Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Radiation therapy.
Who it may be relevant to
Registry conditions: Oncology, Breast Cancer, Prostate Cancer, Gynecologic Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Australia, Belgium, Canada, Denmark +4
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Radiation Radiation therapy
    Radiation therapy on the CE marked and FDA approved MR-Linac

Primary outcome measures

  • Progression-free Survival [Time frame: 3 months after MR-Linac treatment]
  • Progression-free Survival [Time frame: 6 months after MR-Linac treatment]
  • Progression-free Survival [Time frame: 24 months after MR-Linac treatment]
  • Survival [Time frame: 3 months after MR-Linac treatment]
  • Survival [Time frame: 6 months after MR-Linac treatment]
  • Survival [Time frame: 24 months after MR-Linac treatment]
  • Disease-free Survival [Time frame: 3 months after MR-Linac treatment]
  • Disease-free Survival [Time frame: 6 months after MR-Linac treatment]
  • Disease-free Survival [Time frame: 24 months after MR-Linac treatment]
  • Patient reported Health related quality of life (HRQoL). [Time frame: 3 months after treatment.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Netherlands · 5 centers
  • Netherlands Cancer Institute, Antoni van Leeuwenhoek Hospital — Amsterdam
  • Radiotherapiegroep — Deventer
  • Radiotherapeutisch Instituut Friesland (RIF) — Leeuwarden
  • Radboud UMC — Nijmegen
  • University Medical Center Utrecht — Utrecht
United States · 3 centers
  • Allegheny Health Network — Pittsburgh
  • Md Anderson Cancer Center — Houston
  • Medical College of Wisconsin — Milwaukee
Canada · 2 centers
  • Sunnybrook Health Sciences Centre/Odette Cancer Centre — Toronto
  • University Health Network - Princess Margaret Cancer Center — Toronto
Italy · 2 centers
  • Università degli Studi di Brescia — Brescia
  • IRCCS Ospedale Sacro Cuore Don Calabria — Negrar
United Kingdom · 2 centers
  • The Royal Marsden and The Institute of Cancer Research National Institute for Health Resea — London
  • The Christie National Health Service Foundation Trust — Manchester
Australia · 1 center
  • Austin Health - Olivia Newton-John Cancer Wellness and Research Centre — Melbourne
Belgium · 1 center
  • Insitut Jules Bordet — Brussels
Denmark · 1 center
  • Odense Universitetshospital — Odense
Germany · 1 center
  • Universitätsklinikum Tübingen — Tübingen

Publications

  • Cooper S, Alexander S, Cherry C, Chick J, Dassen MG, Dunlop A, Hassan S, Herbert T, Mason F, Mitchell A, Nill S, Oelfke U, Pos F, Saifuddin M, Westley R, van der Heide UA, Vesprini D, Tree A. Acute adverse events in the DESTINATION 1 trial: A prospective prostate SBRT dose de-escalation feasibility study. Radiother Oncol. 2026 Mar;216:111363. doi: 10.1016/j.radonc.2026.111363. Epub 2026 Jan 6. PMID 41506574
  • Tan H, Stewart J, Ruschin M, Wang MH, Myrehaug S, Tseng CL, Detsky J, Husain Z, Chen H, Sahgal A, Soliman H. Inter-fraction dynamics during post-operative 5 fraction cavity hypofractionated stereotactic radiotherapy with a MR LINAC: a prospective serial imaging study. J Neurooncol. 2022 Feb;156(3):569-577. doi: 10.1007/s11060-021-03938-w. Epub 2022 Jan 3. PMID 34981300
  • de Mol van Otterloo SR, Christodouleas JP, Blezer ELA, Akhiat H, Brown K, Choudhury A, Eggert D, Erickson BA, Faivre-Finn C, Fuller CD, Goldwein J, Hafeez S, Hall E, Harrington KJ, van der Heide UA, Huddart RA, Intven MPW, Kirby AM, Lalondrelle S, McCann C, Minsky BD, Mook S, Nowee ME, Oelfke U, Orrling K, Sahgal A, Sarmiento JG, Schultz CJ, Tersteeg RJHA, Tijssen RHN, Tree AC, van Triest B, Hall PMID 33014774

Identifiers

NCT: NCT04075305 · NL66650.041.18

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗