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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04075305
Recruitment Status : Recruiting
First Posted : August 30, 2019
Last Update Posted : August 27, 2021
Sponsor:
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
Information provided by (Responsible Party):
Helena M Verkooijen, UMC Utrecht

Study Description
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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.

Condition or disease Intervention/treatment
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 Head and Neck Cancer Head and Neck Neoplasms Head and Neck Tumor Tumor Neoplasms Bladder Cancer Bladder Neoplasm Liver Cancer Liver Neoplasms Liver Metastases Oligometastases Radiation: Radiation therapy

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
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 6000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: The Multiple Outcome Evaluation of Radiation Therapy Using the MR-Linac Study
Actual Study Start Date : February 1, 2019
Estimated Primary Completion Date : February 1, 2024
Estimated Study Completion Date : February 1, 2024

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Brain cancer Radiation: Radiation therapy
Radiation therapy on the CE marked and FDA approved MR-Linac
Lung cancer Radiation: Radiation therapy
Radiation therapy on the CE marked and FDA approved MR-Linac
Esophageal cancer Radiation: Radiation therapy
Radiation therapy on the CE marked and FDA approved MR-Linac
Breast Cancer Radiation: Radiation therapy
Radiation therapy on the CE marked and FDA approved MR-Linac
Head and Neck Cancer Radiation: Radiation therapy
Radiation therapy on the CE marked and FDA approved MR-Linac
Pancreatic cancer Radiation: Radiation therapy
Radiation therapy on the CE marked and FDA approved MR-Linac
Gynecological cancer Radiation: Radiation therapy
Radiation therapy on the CE marked and FDA approved MR-Linac
Rectal cancer Radiation: Radiation therapy
Radiation therapy on the CE marked and FDA approved MR-Linac
Prostate cancer Radiation: Radiation therapy
Radiation therapy on the CE marked and FDA approved MR-Linac
Bladder cancer Radiation: Radiation therapy
Radiation therapy on the CE marked and FDA approved MR-Linac
Oligometastases Radiation: Radiation therapy
Radiation therapy on the CE marked and FDA approved MR-Linac
Liver cancer Radiation: Radiation therapy
Radiation therapy on the CE marked and FDA approved MR-Linac
Other types of cancer Radiation: Radiation therapy
Radiation therapy on the CE marked and FDA approved MR-Linac


Outcome Measures
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Primary Outcome Measures :
  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.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04075305


Contacts
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Contact: Tessa Leer T +31 (0)88 75 63707 T.Leer@umcutrecht.nl

Locations
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United States, Texas
Md Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Clifton D Fuller    713-745-4404    cdfuller@mdanderson.org   
United States, Wisconsin
Medical College of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: William A Hall         
Canada, Ontario
Sunnybrook Health Sciences Centre/Odette Cancer Centre Recruiting
Toronto, Ontario, Canada
Contact: Arjun Sahgal         
Denmark
Odense Universitetshospital Recruiting
Odense, Funen, Denmark, 5000
Contact: T. Schytte       Tine.Schytte@rsyd.dk   
Netherlands
Netherlands Cancer Institute, Antoni van Leeuwenhoek Hospital Recruiting
Amsterdam, Netherlands
Contact: Marlies N Nowee         
University Medical Center Utrecht Recruiting
Utrecht, Netherlands, 3508GA
Contact: Helena M Verkooijen, Prof, Dr       h.m.verkooijen@umcutrecht.nl   
Contact: Tessa Leer       T.Leer@umcutrecht.nl   
Sub-Investigator: Tessa Leer         
Principal Investigator: Helena M Verkooijen, Prof, Dr         
United Kingdom
The Royal Marsden and The Institute of Cancer Research National Institute for Health Research Biomedical Research Centre Recruiting
London, United Kingdom
Contact: Shaista Hafeez         
The Christie National Health Service Foundation Trust Recruiting
Manchester, United Kingdom
Contact: Ananya Choudhury         
Sponsors and Collaborators
UMC Utrecht
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
Investigators
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Principal Investigator: Helena M Verkooijen, Prof, Dr Universitair Medical Centre Utrecht
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Helena M Verkooijen, Prof. Dr., UMC Utrecht
ClinicalTrials.gov Identifier: NCT04075305    
Other Study ID Numbers: NL66650.041.18
First Posted: August 30, 2019    Key Record Dates
Last Update Posted: August 27, 2021
Last Verified: August 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Neoplasms
Prostatic Neoplasms
Pancreatic Neoplasms
Rectal Neoplasms
Head and Neck Neoplasms
Urinary Bladder Neoplasms
Esophageal Neoplasms
Brain Neoplasms
Liver Neoplasms
Lung Neoplasms
Breast Neoplasms
Genital Neoplasms, Female
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
 Genital Diseases, Male
Genital Diseases
Urogenital Diseases
Prostatic Diseases
Male Urogenital Diseases
Digestive System Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Gastrointestinal Diseases
Intestinal Diseases