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NCT Number: NCT04075305

The MOMENTUM Study: 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.

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Key information

Conditions

Oncology Bladder Cancer Bladder Neoplasm Brain Cancer Brain Diseases Brain Neoplasms Brain Tumor Breast Cancer Breast Diseases Breast Neoplasms Breast Tumor Central Nervous System Diseases Central Nervous System Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Esophageal Cancer Esophageal Diseases Esophageal Neoplasm Esophageal Neoplasms Esophageal Tumor Esophagus Cancer Esophagus Neoplasm Esophagus Tumor Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases Genital Diseases, Female Genital Diseases, Male Genital Neoplasms, Female Genital Neoplasms, Male Gynecologic Cancer Gynecologic Tumor Head and Neck Cancer Head and Neck Neoplasms Head and Neck Tumor Intestinal Diseases Intestinal Neoplasms Liver Cancer Liver Diseases Liver Metastases Liver Neoplasms Lung Cancer Lung Diseases Lung Neoplasm Lung Neoplasms Lung Tumor Male Urogenital Diseases Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms Oligometastases Pancreatic Cancer Pancreatic Diseases Pancreatic Neoplasms Pancreatic Tumor Prostate Cancer Prostate Neoplasm Prostate Tumor Prostatic Diseases Prostatic Neoplasms Quality of Life Radiation Injuries Radiation Toxicity Rectal Cancer Rectal Diseases Rectal Neoplasms Rectal Tumor Respiratory Tract Diseases Respiratory Tract Neoplasms Skin Diseases Skin and Connective Tissue Diseases Thoracic Neoplasms Tumor Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Austin Health - Olivia Newton-John Cancer Wellness and Research Centre, Melbourne, Australia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

radiation therapy

Radiation

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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'.

  15. 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'.

  16. 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'.

  17. 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'.

  18. 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.

  19. 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.

  20. 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.

  21. 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.

  22. 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.

  23. 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.

  24. 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.

  25. 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.

  26. 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.

  27. 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.

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

    Time frame: 2 years

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

Study contacts

Contact information is provided by the study sponsor or research team.

Tessa Leer

CONTACT

[email protected]

T +31 (0)88 75 63707

Sponsors and collaborators

Lead sponsor

UMC Utrecht

Other

Collaborators

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

Registry information

Official study title

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

Acronym: MOMENTUM

Important dates

Study start
2019
Primary completion
2030
Study completion
2030
First posted
Aug 30, 2019
Registry last updated
Mar 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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