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

NCT04075305 | Recruiting DMC FDA Device

• 1 other identifier: NL66650.041.18
• Study Type: observational
• Target: 8,000
• Locations: 9 countries
• Sites: 18

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.

Conditions

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

Outcome Measures

Primary Outcomes (28)

• 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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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'.

  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'.

  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'.

  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'.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  2 year follow up.

• Toxicity in common toxicity criteria for adverse events (CTCAE).

  Disease-specific toxicity is obtained from the hospital information system.

  2 years

Study Arms (13)

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

Interventions

Radiation therapy RADIATION

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

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• MRI contraindications as per usual clinical care, such as (possible) pregnancy; claustrophobia and metal or electronic implants not compatible with MRI.

Sponsors & Collaborators

• UMC Utrecht: lead
• Elekta Limited: collaborator
• The Netherlands Cancer Institute: collaborator
• Sunnybrook Health Sciences Centre: collaborator
• M.D. Anderson Cancer Center: collaborator
• The Christie NHS Foundation Trust: collaborator
• Royal Marsden NHS Foundation Trust: collaborator
• Medical College of Wisconsin: collaborator
• Odense University Hospital: collaborator
• Radboud University Medical Center: collaborator
• Radiotherapiegroep: collaborator
• Jules Bordet Institute: collaborator
• University Hospital Tuebingen: collaborator
• Radiotherapeutic Institute Friesland: collaborator
• Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute): collaborator
• IRCCS Sacro Cuore Don Calabria di Negrar: collaborator
• Austin Health: collaborator
• Princess Margaret Hospital, Canada: collaborator
• Università degli Studi di Brescia: collaborator

Study Sites (18)

Allegheny Health Network

Pittsburgh, Pennsylvania, 15212, United States

RECRUITING

Md Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

RECRUITING

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

Melbourne, Australia

NOT YET RECRUITING

Insitut Jules Bordet

Brussels, Belgium

NOT YET RECRUITING

Sunnybrook Health Sciences Centre/Odette Cancer Centre

Toronto, Ontario, Canada

RECRUITING

University Health Network - Princess Margaret Cancer Center

Toronto, Canada

RECRUITING

Odense Universitetshospital

Odense, Funen, 5000, Denmark

RECRUITING

Universitätsklinikum Tübingen

Tübingen, Germany

RECRUITING

Università degli Studi di Brescia

Brescia, Italy

NOT YET RECRUITING

IRCCS Ospedale Sacro Cuore Don Calabria

Negrar, Italy

RECRUITING

Netherlands Cancer Institute, Antoni van Leeuwenhoek Hospital

Amsterdam, Netherlands

RECRUITING

Radiotherapiegroep

Deventer, Netherlands

RECRUITING

Radiotherapeutisch Instituut Friesland (RIF)

Leeuwarden, Netherlands

NOT YET RECRUITING

Radboud UMC

Nijmegen, Netherlands

RECRUITING

University Medical Center Utrecht

Utrecht, 3508GA, Netherlands

RECRUITING

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

London, United Kingdom

RECRUITING

The Christie National Health Service Foundation Trust

Manchester, United Kingdom

RECRUITING

Related Publications (3)

• 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 DERIVED

• 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 DERIVED

• 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 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.

  PMID: 33014774 DERIVED

MeSH Terms

Conditions

Neoplasms; Breast Neoplasms; Prostatic Neoplasms; Brain Neoplasms; Genital Neoplasms, Female; Radiation Injuries; Rectal Neoplasms; Lung Neoplasms; Esophageal Neoplasms; Pancreatic Neoplasms; Head and Neck Neoplasms; Urinary Bladder Neoplasms; Liver Neoplasms

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Wounds and Injuries; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Esophageal Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Endocrine System Diseases; Urologic Neoplasms; Urinary Bladder Diseases; Urologic Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Helena M Verkooijen, Prof, Dr

  Universitair Medical Centre Utrecht

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tessa Leer

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: March 22, 2019
• First Posted: August 30, 2019
• Study Start: February 1, 2019
• Primary Completion (Estimated): February 1, 2030
• Study Completion (Estimated): August 1, 2030
• Last Updated: March 5, 2026

Record last verified: 2026-01

Locations

US (3); CA (2); GB (2); IT (2); AU (1); BE (1); DK (1); DE (1); NL (5)