OncologyMOMENTUMNCT04075305
The MOMENTUM Study: The Multiple Outcome Evaluation of Radiation Therapy Using the MR-Linac Study
An observational study of Oncology and Breast Cancer, run by UMC Utrecht at 18 sites in 9 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oncology, Breast Cancer, Prostate Cancer
- What is being tested?
- Radiation therapy
- Type of treatment
- Surgery or procedure
- How many people
- 8,000 participants
- Where
- 18 sitesin 9 countries
- Study dates
- 1 Feb 2019to 1 Aug 2030
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients receiving treatment and/or imaging on an MR-Linac machine are eligible for enrolment. Patients must meet eligibility criteria and provide informed consent to be enrolled.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
18 sites in 9 countries. Contact the study team or a site near you to ask about taking part.
18 sites in 9 countries
Netherlands5 sites, 5 recruiting
- Recruiting
Netherlands Cancer Institute, Antoni van Leeuwenhoek Hospital
Amsterdam
Marlies N Nowee
- Recruiting
Radiotherapiegroep
Deventer
Paul Jeene
- Not yet recruiting
Radiotherapeutisch Instituut Friesland (RIF)
Leeuwarden
Peter de Boer
- Recruiting
Radboud UMC
Nijmegen
Linda Kerkmeijer
- Recruiting
University Medical Center Utrecht
Utrecht, 3508GA
Helena M Verkooijen, Prof, Dr, h.m.verkooijen@umcutrecht.nl
Tessa Leer, T.Leer@umcutrecht.nl
United States3 sites, 3 recruiting
- Recruiting
Md Anderson Cancer Center
Houston, Texas, 77030
Clifton D Fuller, (713) 745-4404, cdfuller@mdanderson.org
- Recruiting
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
William A Hall
- Recruiting
Allegheny Health Network
Pittsburgh, Pennsylvania, 15212
Tom Colonias
Canada2 sites, 2 recruiting
- Recruiting
Sunnybrook Health Sciences Centre/Odette Cancer Centre
Toronto, Ontario
Arjun Sahgal
- Recruiting
University Health Network - Princess Margaret Cancer Center
Toronto
Michael Velec
Italy2 sites, 2 recruiting
- Not yet recruiting
Università degli Studi di Brescia
Brescia
Stefano Magrini
- Recruiting
IRCCS Ospedale Sacro Cuore Don Calabria
Negrar
Filippo Alongi
United Kingdom2 sites, 2 recruiting
- Recruiting
The Royal Marsden and The Institute of Cancer Research National Institute for Health Research Biomedical Research Centre
London
Shaista Hafeez
- Recruiting
The Christie National Health Service Foundation Trust
Manchester
Ananya Choudhury
Australia1 site, 1 recruiting
- Not yet recruiting
Austin Health - Olivia Newton-John Cancer Wellness and Research Centre
Melbourne
Sweet Ping
Belgium1 site, 1 recruiting
- Not yet recruiting
Insitut Jules Bordet
Brussels
Robbe van den Begin
Denmark1 site, 1 recruiting
- Recruiting
Odense Universitetshospital
Odense, Funen, 5000
Tine Schytte, Tine.Schytte@rsyd.dk
Germany1 site, 1 recruiting
- Recruiting
Universitätsklinikum Tübingen
Tübingen
Cihan Gani
About this study
Official title: The Multiple Outcome Evaluation of Radiation Therapy Using the MR-Linac Study
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.
Read the 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.
- Conditions
- Oncology, Breast Cancer, Prostate Cancer, Gynecologic Cancer, Brain Tumor, Brain Cancer
- Being tested
- Radiation therapy
- Medical subject headings
- Neoplasms, Breast Neoplasms, Prostatic Neoplasms, Brain Neoplasms, Genital Neoplasms, Female, Radiation Injuries, Rectal Neoplasms, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiation therapyRadiation
Radiation therapy on the CE marked and FDA approved MR-Linac
| Study group | Role | What they receive |
|---|---|---|
| Brain cancer | Not described Receives: Radiation: Radiation therapy | |
| Lung cancer | Not described Receives: Radiation: Radiation therapy | |
| Esophageal cancer | Not described Receives: Radiation: Radiation therapy | |
| Breast Cancer | Not described Receives: Radiation: Radiation therapy | |
| Head and Neck Cancer | Not described Receives: Radiation: Radiation therapy | |
| Pancreatic cancer | Not described Receives: Radiation: Radiation therapy | |
| Gynecological cancer | Not described Receives: Radiation: Radiation therapy | |
| Rectal cancer | Not described Receives: Radiation: Radiation therapy | |
| Prostate cancer | Not described Receives: Radiation: Radiation therapy | |
| Bladder cancer | Not described Receives: Radiation: Radiation therapy | |
| Oligometastases | Not described Receives: Radiation: Radiation therapy | |
| Liver cancer | Not described Receives: Radiation: Radiation therapy | |
| Other types of cancer | Not described Receives: Radiation: Radiation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free Survival
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.
Measured: 3 months after MR-Linac treatment
Progression-free Survival
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.
Measured: 6 months after MR-Linac treatment
Progression-free Survival
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.
Measured: 24 months after MR-Linac treatment
Survival
Overall survival of participating patients will be obtained from the hospital information systems. Patient follow-up is conducted to local standard of care practices.
Measured: 3 months after MR-Linac treatment
Survival
Overall survival of participating patients will be obtained from the hospital information systems. Patient follow-up is conducted to local standard of care practices.
Measured: 6 months after MR-Linac treatment
Survival
Overall survival of participating patients will be obtained from the hospital information systems. Patient follow-up is conducted to local standard of care practices.
Measured: 24 months after MR-Linac treatment
Disease-free Survival
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.
Measured: 3 months after MR-Linac treatment
Disease-free Survival
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.
Measured: 6 months after MR-Linac treatment
Disease-free Survival
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.
Measured: 24 months after MR-Linac treatment
Patient reported Health related quality of life (HRQoL).
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.
Measured: 3 months after treatment.
Patient reported Health related quality of life (HRQoL).
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.
Measured: 6 months after treatment.
Patient reported Health related quality of life (HRQoL).
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.
Measured: 12 months after treatment.
Patient reported Health related quality of life (HRQoL).
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.
Measured: 24 months after treatment.
Patient reported Health related quality of life (HRQoL).
Generic patient reported quality of life is captured by The EuroQol (EQ)-5D-5L questionnaire. This includes a descriptive system questionnaire and visual analogue scale (VAS). The descriptive system scores five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) from 1 to 5 where 1 means having no problems, and 5 means extreme problems or unable to participate. The digits can be combined in a 5-digit code to describe the overall health status. For example, 12111. The VAS records the overall current health on a vertical visual analogue scale from 0 to 100, respectively 'the worst health you can imagine' to 'the best health you can imagine'.
Measured: 3 months after treatment.
Patient reported Health related quality of life (HRQoL).
Generic patient reported quality of life is captured by The EuroQol (EQ)-5D-5L questionnaire. This includes a descriptive system questionnaire and visual analogue scale (VAS). The descriptive system scores five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) from 1 to 5 where 1 means having no problems, and 5 means extreme problems or unable to participate. The digits can be combined in a 5-digit code to describe the overall health status. For example, 12111. The VAS records the overall current health on a vertical visual analogue scale from 0 to 100, respectively 'the worst health you can imagine' to 'the best health you can imagine'.
Measured: 6 months after treatment.
Patient reported Health related quality of life (HRQoL).
Generic patient reported quality of life is captured by The EuroQol (EQ)-5D-5L questionnaire. This includes a descriptive system questionnaire and visual analogue scale (VAS). The descriptive system scores five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) from 1 to 5 where 1 means having no problems, and 5 means extreme problems or unable to participate. The digits can be combined in a 5-digit code to describe the overall health status. For example, 12111. The VAS records the overall current health on a vertical visual analogue scale from 0 to 100, respectively 'the worst health you can imagine' to 'the best health you can imagine'.
Measured: 12 months after treatment.
Patient reported Health related quality of life (HRQoL).
Generic patient reported quality of life is captured by The EuroQol (EQ)-5D-5L questionnaire. This includes a descriptive system questionnaire and visual analogue scale (VAS). The descriptive system scores five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) from 1 to 5 where 1 means having no problems, and 5 means extreme problems or unable to participate. The digits can be combined in a 5-digit code to describe the overall health status. For example, 12111. The VAS records the overall current health on a vertical visual analogue scale from 0 to 100, respectively 'the worst health you can imagine' to 'the best health you can imagine'.
Measured: 24 months after treatment.
Patient reported tumor specific quality of life (QoL).
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.
Measured: 3 months after treatment.
Patient reported tumor specific quality of life (QoL).
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.
Measured: 6 months after treatment.
Patient reported tumor specific quality of life (QoL).
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.
Measured: 12 months after treatment.
Patient reported tumor specific quality of life (QoL).
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.
Measured: 24 months after treatment.
Acute toxicity in common toxicity criteria for adverse events (CTCAE).
Disease-specific toxicity is obtained from the hospital information system. Toxicities are reported according to the Common Terminology Criteria for Adverse Events (CTCAE) dictionary.
Measured: 3 months after treatment.
Acute toxicity in common toxicity criteria for adverse events (CTCAE).
Disease-specific toxicity is obtained from the hospital information system. Toxicities are reported according to the Common Terminology Criteria for Adverse Events (CTCAE) dictionary.
Measured: 6 months after treatment.
Acute toxicity in common toxicity criteria for adverse events (CTCAE).
Disease-specific toxicity is obtained from the hospital information system. Toxicities are reported according to the Common Terminology Criteria for Adverse Events (CTCAE) dictionary.
Measured: 12 months after treatment.
Acute toxicity in common toxicity criteria for adverse events (CTCAE).
Disease-specific toxicity is obtained from the hospital information system. Toxicities are reported according to the Common Terminology Criteria for Adverse Events (CTCAE) dictionary.
Measured: 24 months after treatment.
Clinical tumor response.
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.
Measured: 2 year follow up.
Pathological tumor response.
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.
Measured: 2 year follow up.
Toxicity in common toxicity criteria for adverse events (CTCAE).
Disease-specific toxicity is obtained from the hospital information system.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2019
- Study start1 Feb 2019
- Primary completion1 Feb 2030 (estimated)
- Study completion1 Aug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for OncologyStudies of the same condition, open and under way.
- More trials run by UMC UtrechtThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 8,000 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- UMC Utrecht
- Sponsor type
- University, hospital or other
- Collaborators
- The Netherlands Cancer Institute, Sunnybrook Health Sciences Centre, M.D. Anderson Cancer Center, The Christie NHS Foundation Trust, Royal Marsden NHS Foundation Trust, Medical College of Wisconsin, Elekta Limited, Odense University Hospital, Radboud University Medical Center, Radiotherapiegroep, Jules Bordet Institute, University Hospital Tuebingen, Radiotherapeutic Institute Friesland, Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute), IRCCS Sacro Cuore Don Calabria di Negrar, Austin Health, Princess Margaret Hospital, Canada, Università degli Studi di Brescia
- Responsible party
- Principal investigator, Helena M Verkooijen, UMC Utrecht
- Investigators
- Helena M Verkooijen, Prof, Dr, Principal investigator, Universitair Medical Centre Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04075305
- Sponsor's protocol ID
- NL66650.041.18
- Acronym
- MOMENTUM
- Status last verified
- Jan 2026
- First submitted
- 22 Mar 2019
- Last updated
- 5 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
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.
PubMed 41506574Tan 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.
PubMed 34981300de 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 WA, Verkooijen HM. The MOMENTUM Study: An International Registry for the Evidence-Based Introduction of MR-Guided Adaptive Therapy. Front Oncol. 2020 Sep 7;10:1328. doi: 10.3389/fonc.2020.01328. eCollection 2020.
PubMed 33014774
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Multiple Outcome Evaluation of Radiation Therapy Using the MR-Linac Study
- ClinicalTrials.gov ID
- NCT04075305
- Acronym / sponsor ID
- MOMENTUM / NL66650.041.18
- Conditions
- Oncology, Breast Cancer, Prostate Cancer, Gynecologic Cancer, Brain Tumor, Brain Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 8,000 participants (estimated)
- Lead sponsor
- UMC UtrechtUniversity, hospital or other
- Collaborators
- The Netherlands Cancer Institute, Sunnybrook Health Sciences Centre, M.D. Anderson Cancer Center, The Christie NHS Foundation Trust, Royal Marsden NHS Foundation Trust, Medical College of Wisconsin, Elekta Limited, Odense University Hospital, Radboud University Medical Center, Radiotherapiegroep, Jules Bordet Institute, University Hospital Tuebingen, Radiotherapeutic Institute Friesland, Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute), IRCCS Sacro Cuore Don Calabria di Negrar, Austin Health, Princess Margaret Hospital, Canada, Università degli Studi di Brescia
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 1 Feb 2030 (estimated)
- Study completion
- 1 Aug 2030 (estimated)
- First posted
- 30 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 13
| Arm | Type | Receives |
|---|---|---|
| Brain cancer | – | Radiation: Radiation therapy |
| Lung cancer | – | Radiation: Radiation therapy |
| Esophageal cancer | – | Radiation: Radiation therapy |
| Breast Cancer | – | Radiation: Radiation therapy |
| Head and Neck Cancer | – | Radiation: Radiation therapy |
| Pancreatic cancer | – | Radiation: Radiation therapy |
| Gynecological cancer | – | Radiation: Radiation therapy |
| Rectal cancer | – | Radiation: Radiation therapy |
| Prostate cancer | – | Radiation: Radiation therapy |
| Bladder cancer | – | Radiation: Radiation therapy |
| Oligometastases | – | Radiation: Radiation therapy |
| Liver cancer | – | Radiation: Radiation therapy |
| Other types of cancer | – | Radiation: Radiation therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients receiving treatment and/or imaging on an MR-Linac machine are eligible for enrolment. Patients must meet eligibility criteria and provide informed consent to be enrolled.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radiation therapyRadiation therapy on the CE marked and FDA approved MR-Linac | Radiation | Bladder cancer, Brain cancer, Breast Cancer, Esophageal cancer, Gynecological cancer, Head and Neck Cancer, Liver cancer, Lung cancer, Oligometastases, Other types of cancer, Pancreatic cancer, Prostate cancer, Rectal cancer |
Primary outcome
Progression-free Survival
Time frame: 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.
Progression-free Survival
Time frame: 6 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.
Progression-free Survival
Time frame: 24 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
Time frame: 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.
Survival
Time frame: 6 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.
Survival
Time frame: 24 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
Time frame: 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.
Disease-free Survival
Time frame: 6 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.
Disease-free Survival
Time frame: 24 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).
Time frame: 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 Health related quality of life (HRQoL).
Time frame: 6 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 Health related quality of life (HRQoL).
Time frame: 12 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 Health related quality of life (HRQoL).
Time frame: 24 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 Health related quality of life (HRQoL).
Time frame: 3 months after treatment.
Generic patient reported quality of life is captured by The EuroQol (EQ)-5D-5L questionnaire. This includes a descriptive system questionnaire and visual analogue scale (VAS). The descriptive system scores five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) from 1 to 5 where 1 means having no problems, and 5 means extreme problems or unable to participate. The digits can be combined in a 5-digit code to describe the overall health status. For example, 12111. The VAS records the overall current health on a vertical visual analogue scale from 0 to 100, respectively 'the worst health you can imagine' to 'the best health you can imagine'.
Patient reported Health related quality of life (HRQoL).
Time frame: 6 months after treatment.
Generic patient reported quality of life is captured by The EuroQol (EQ)-5D-5L questionnaire. This includes a descriptive system questionnaire and visual analogue scale (VAS). The descriptive system scores five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) from 1 to 5 where 1 means having no problems, and 5 means extreme problems or unable to participate. The digits can be combined in a 5-digit code to describe the overall health status. For example, 12111. The VAS records the overall current health on a vertical visual analogue scale from 0 to 100, respectively 'the worst health you can imagine' to 'the best health you can imagine'.
Patient reported Health related quality of life (HRQoL).
Time frame: 12 months after treatment.
Generic patient reported quality of life is captured by The EuroQol (EQ)-5D-5L questionnaire. This includes a descriptive system questionnaire and visual analogue scale (VAS). The descriptive system scores five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) from 1 to 5 where 1 means having no problems, and 5 means extreme problems or unable to participate. The digits can be combined in a 5-digit code to describe the overall health status. For example, 12111. The VAS records the overall current health on a vertical visual analogue scale from 0 to 100, respectively 'the worst health you can imagine' to 'the best health you can imagine'.
Patient reported Health related quality of life (HRQoL).
Time frame: 24 months after treatment.
Generic patient reported quality of life is captured by The EuroQol (EQ)-5D-5L questionnaire. This includes a descriptive system questionnaire and visual analogue scale (VAS). The descriptive system scores five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) from 1 to 5 where 1 means having no problems, and 5 means extreme problems or unable to participate. The digits can be combined in a 5-digit code to describe the overall health status. For example, 12111. The VAS records the overall current health on a vertical visual analogue scale from 0 to 100, respectively 'the worst health you can imagine' to 'the best health you can imagine'.
Patient reported tumor specific quality of life (QoL).
Time frame: 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.
Patient reported tumor specific quality of life (QoL).
Time frame: 6 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.
Patient reported tumor specific quality of life (QoL).
Time frame: 12 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.
Patient reported tumor specific quality of life (QoL).
Time frame: 24 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).
Time frame: 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.
Acute toxicity in common toxicity criteria for adverse events (CTCAE).
Time frame: 6 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.
Acute toxicity in common toxicity criteria for adverse events (CTCAE).
Time frame: 12 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.
Acute toxicity in common toxicity criteria for adverse events (CTCAE).
Time frame: 24 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.
Time frame: 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.
Time frame: 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).
Time frame: 2 years
Disease-specific toxicity is obtained from the hospital information system.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2026.
- Derived from this study: PubMed 41506574Cooper 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.
- Derived from this study: PubMed 34981300Tan 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.
- Derived from this study: PubMed 33014774de 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 WA, Verkooijen HM. The MOMENTUM Study: An International Registry for the Evidence-Based Introduction of MR-Guided Adaptive Therapy. Front Oncol. 2020 Sep 7;10:1328. doi: 10.3389/fonc.2020.01328. eCollection 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Helena M Verkooijen, Prof, Dr principal investigator
Universitair Medical Centre Utrecht
18 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oncology and Breast Cancer, run by UMC Utrecht at 18 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in Netherlands, United States, Canada, Italy, United Kingdom and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tessa Leer (T +31 (0)88 75 63707, T.Leer@umcutrecht.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free Survival (time frame: 3 months after MR-Linac treatment). The study lists 28 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04075305, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2026; AzTrials last refreshed its copy on 6 Nov 2026.