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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

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

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Нидерланды · 5 центров

• Netherlands Cancer Institute, Antoni van Leeuwenhoek Hospital — Amsterdam
• Radiotherapiegroep — Deventer
• Radiotherapeutisch Instituut Friesland (RIF) — Leeuwarden
• Radboud UMC — Nijmegen
• University Medical Center Utrecht — Utrecht

США · 3 центра

• Allegheny Health Network — Pittsburgh
• Md Anderson Cancer Center — Houston
• Medical College of Wisconsin — Milwaukee

Канада · 2 центра

• Sunnybrook Health Sciences Centre/Odette Cancer Centre — Toronto
• University Health Network - Princess Margaret Cancer Center — Toronto

Италия · 2 центра

• Università degli Studi di Brescia — Brescia
• IRCCS Ospedale Sacro Cuore Don Calabria — Negrar

Великобритания · 2 центра

• The Royal Marsden and The Institute of Cancer Research National Institute for Health Resea — London
• The Christie National Health Service Foundation Trust — Manchester

Австралия · 1 центр

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

Бельгия · 1 центр

• Insitut Jules Bordet — Brussels

Дания · 1 центр

• Odense Universitetshospital — Odense

Германия · 1 центр

• Universitätsklinikum Tübingen — Tübingen

Публикации

• 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

Идентификаторы

NCT: NCT04075305 · NL66650.041.18

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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