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

Conditions

Bladder Cancer, Bladder Neoplasm, Brain Cancer, Brain Tumor, Breast Cancer, Breast Tumor, Esophageal Cancer, Esophageal Neoplasm, Esophageal Tumor, Esophagus Cancer, Esophagus Neoplasm, Esophagus Tumor, Gynecologic Cancer, Gynecologic Tumor, Head and Neck Cancer, Head and Neck Neoplasms, Head and Neck Tumor, Liver Cancer, Liver Metastases, Liver Neoplasms, Lung Cancer, Lung Neoplasm, Lung Tumor, Neoplasms, Oligometastases, Oncology, Pancreatic Cancer, Pancreatic Neoplasms, Pancreatic Tumor, Prostate Cancer, Prostate Neoplasm, Prostate Tumor, Quality of Life, Radiation Toxicity, Rectal Cancer, Rectal Neoplasms, Rectal Tumor, Tumor

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.

Peltenburg JE, Westley R, Daamen LA, Tissier R, Aitken KL, Bernchou U, Boeke S, Braam PM, Hosni A, Intven MPW, Janssen T, Sonke JJ, Straza MW, Hall WA, Nowee ME.

2025-08-21

10.1016/j.prro.2025.07.006

Quantifying the dosimetric impact of online daily adaptation for MR-guided RT in cervical cancer

Amerah Alshamrani, Robert Chuter, Marianne Aznar, Peter Hoskin, Claire Nelder et al. (8 authors)

Acta Oncologica2025-05-19

10.2340/1651-226x.2025.42898

Quantification and Dosimetric Impact of Normal Organ Motion During Adaptive Radiation Therapy Planning Using a 1.5 Tesla Magnetic Resonance-Equipped Linear Accelerator (MR-Linac).

Wittmann D, Paulson ES, Banerjee A, Banla LI, Schultz C, Awan M, Chen X, Omari EA, Straza M, Li XA, Erickson B, Hall WA.

2025-04-11

10.1016/j.adro.2025.101758

Quality of Life and Toxicity in Patients With Pancreatic Ductal Adenocarcinoma Treated With Online Adaptive Stereotactic Magnetic Resonance Guided Radiation Therapy.

Westerhoff JM, Scheepens JCM, van Wolffelaar FF, Bernchou U, Bahij R, Erickson BA, Christodouleas JP, Ng SSW, Gani C, Choudhury A, Alongi F, Renz P, Colonias AT, Meijer GJ, Schytte T, Intven MPW, Verkooijen HM, Daamen LA, Hall WA.

2025-04-02

10.1016/j.ijrobp.2025.03.046

Treatment time and learning curve analysis of 1.5 T MR-Linac workflows led by radiation oncologists or therapists.

Westerhoff JM, Raaijmakers FJ, Daamen LA, de Groot-van Breugel EN, Meijers LTC, van der Voort van Zyp JRN, Verhoeff JJC, Mook S, Verkooijen HM, Intven MPW.

2024-12-141 citations

10.1016/j.ctro.2024.100901

Quality of life and clinical outcomes in rectal cancer patients treated on a 1.5T MR-Linac within the MOMENTUM study.

Daamen LA, Westerhoff JM, Couwenberg AM, Braam PM, Rütten H, den Hartogh MD, Christodouleas JP, Hall WA, Verkooijen HM, Intven MPW.

2024-01-043 citations

10.1016/j.ctro.2023.100721

Clinical outcomes after online adaptive MR-guided stereotactic body radiotherapy for pancreatic tumors on a 1.5 T MR-linac

Hidde Eijkelenkamp, Guus Grimbergen, Lois A. Daamen, H.D. Heerkens, Saskia van de Ven et al. (14 authors)

Frontiers in Oncology2023-10-0314 citations

10.3389/fonc.2023.1040673

Inter-fraction dynamics during post-operative 5 fraction cavity hypofractionated stereotactic radiotherapy with a MR LINAC: a prospective serial imaging study.

Tan H, Stewart J, Ruschin M, Wang MH, Myrehaug S, Tseng CL, Detsky J, Husain Z, Chen H, Sahgal A, Soliman H.

2022-01-0311 citations

10.1007/s11060-021-03938-w

Patterns of Care, Tolerability, and Safety of the First Cohort of Patients Treated on a Novel High-Field MR-Linac Within the MOMENTUM Study: Initial Results From a Prospective Multi-Institutional Registry.

de Mol van Otterloo SR, Christodouleas JP, Blezer ELA, Akhiat H, Brown K, Choudhury A, Eggert D, Erickson BA, Daamen LA, 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, Philippens MEP, Sahgal A, Schultz CJ, Tersteeg RJHA, Tijssen RHN, Tree AC, van Triest B, Tseng CL, Hall WA, Verkooijen HM, MR-Linac Consortium.

2021-07-1342 citations

10.1016/j.ijrobp.2021.07.003

Lutetium-177-PSMA-I&T as metastases directed therapy in oligometastatic hormone sensitive prostate cancer, a randomized controlled trial.

Privé BM, Janssen MJR, van Oort IM, Muselaers CHJ, Jonker MA, de Groot M, Mehra N, Verzijlbergen JF, Scheenen TWJ, Zámecnik P, Barentsz JO, Gotthardt M, Noordzij W, Vogel WV, Bergman AM, van der Poel HG, Vis AN, Oprea-Lager DE, Gerritsen WR, Witjes JA, Nagarajah J.

2020-09-1432 citations

10.1186/s12885-020-07386-z

The MOMENTUM Study: An International Registry for the Evidence-Based Introduction of MR-Guided Adaptive Therapy

Sophie R. de Mol van Otterloo, John P. Christodouleas, Erwin L. A. Blezer, Hafid Akhiat, Kevin Brown et al. (34 authors)

Frontiers in Oncology2020-09-07136 citations

10.3389/fonc.2020.01328

Interventions

RADIATIONRadiation therapy

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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

No

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

Design outcomes

Primary

Measure	Time frame	Description
Progression-free Survival	3 months after MR-Linac treatment	Progression free survival of participating patients will be obtained from the hospital information systems. Patient follow-up is conducted to local standard of care practices.
Survival	3 months after MR-Linac treatment	Overall survival of participating patients will be obtained from the hospital information systems. Patient follow-up is conducted to local standard of care practices.
Disease-free Survival	3 months after MR-Linac treatment	Disease-free survival of participating patients will be obtained from the hospital information systems. Patient follow-up is conducted to local standard of care practices.
Patient reported Health related quality of life (HRQoL).	3 months after treatment.	Patient reported health related quality of life is captured through a questionnaire the Generic European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30. They include 5 functional scales (physical, role, emotional, cognitive and social), three symptom scales, a global health scale, and six single items. All of these scales and items measures range in score from 0 to 100. A high score on functional or global health status scale represents a high/healthy level of functioning. A high score for a symptom scale represents a high level of symptomatology.
Patient reported tumor specific quality of life (QoL).	3 months after treatment.	Disease-specific patient reported quality of life is captured by a tumor specific EORTC QLQ questionnaire. (Brain-BN20, Breast-BR23, Bladder-BLM30, colorectal-CR29, Gynecological-CX24\&VU34, Head and Neck-HN35, liver-HCC18 (primary) and -LMC21 (metastasis), lung-LC13, esophageal-OES18, prostate-PR2, pancreas-PAN26). They all include a different set of functional scales and symptom scales. All of these scales and items measures range in score from 0 to 100. A high score on functional scale represents a high/healthy level of functioning. A high score for a symptom scale represents a high level of symptomatology.
Acute toxicity in common toxicity criteria for adverse events (CTCAE).	3 months after treatment.	Disease-specific toxicity is obtained from the hospital information system. Toxicities are reported according to the Common Terminology Criteria for Adverse Events (CTCAE) dictionary.
Clinical tumor response.	2 year follow up.	Clinical tumor response in participating patients is obtained from hospital information systems. Clinical patient follow-up and re-staging procedures are conducted to local standard of care practices.
Pathological tumor response.	2 year follow up.	Pathological tumor response in participating patients who undergo surgery are obtained from hospital information systems. Clinical patient follow-up and re-staging procedures are conducted to local standard of care practices.
Toxicity in common toxicity criteria for adverse events (CTCAE).	2 years	Disease-specific toxicity is obtained from the hospital information system.

Countries

Australia, Belgium, Canada, Denmark, Germany, Italy, Netherlands, United Kingdom, United States

Contacts

CONTACTTessa Leer

T.Leer@umcutrecht.nlT +31 (0)88 75 63707

PRINCIPAL_INVESTIGATORHelena M Verkooijen, Prof, Dr

Universitair Medical Centre Utrecht

Outcome results

None listed