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

• ClinicalTrials.gov Identifier: NCT04075305
• Recruitment Status: Recruiting
• First Posted: August 30, 2019
• Last Update Posted: September 28, 2023
• Sponsor: UMC Utrecht
• 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
• Information provided by (Responsible Party): Helena M Verkooijen, UMC Utrecht

Study Description

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

• Study Type: Observational [Patient Registry]
• Estimated Enrollment: 8000 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: May 1, 2025

Groups and Cohorts

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

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

• 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

Contacts

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

Locations

United States, Pennsylvania

Allegheny Health Network; Recruiting

Pittsburgh, Pennsylvania, United States, 15212

Contact: Tom Colonias

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

Australia

Austin Health - Olivia Newton-John Cancer Wellness and Research Centre; Not yet recruiting

Melbourne, Australia

Contact: Sweet Ping

Belgium

Insitut Jules Bordet; Not yet recruiting

Brussel, Belgium

Contact: Robbe van den Begin

Canada, Ontario

Sunnybrook Health Sciences Centre/Odette Cancer Centre; Recruiting

Toronto, Ontario, Canada

Contact: Arjun Sahgal

Canada

University Health Network - Princess Margaret Cancer Center; Recruiting

Toronto, Canada

Contact: Michael Velec

Denmark

Odense Universitetshospital; Recruiting

Odense, Funen, Denmark, 5000

Contact: Tine Schytte Tine.Schytte@rsyd.dk

Germany

Universitätsklinikum Tübingen; Recruiting

Tübingen, Germany

Contact: Cihan Gani

Italy

Università degli Studi di Brescia; Not yet recruiting

Brescia, Italy

Contact: Stefano Magrini

IRCCS Ospedale Sacro Cuore Don Calabria; Recruiting

Negrar, Italy

Contact: Filippo Alongi

Netherlands

Netherlands Cancer Institute, Antoni van Leeuwenhoek Hospital; Recruiting

Amsterdam, Netherlands

Contact: Marlies N Nowee

Radiotherapiegroep; Recruiting

Deventer, Netherlands

Contact: Paul Jeene

Radiotherapeutisch Instituut Friesland (RIF); Not yet recruiting

Leeuwarden, Netherlands

Contact: Peter de Boer

Radboud UMC; Recruiting

Nijmegen, Netherlands

Contact: Linda Kerkmeijer

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

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

Investigators

• Principal Investigator: Helena M Verkooijen, Prof, Dr; Universitair Medical Centre Utrecht

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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.

• 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
• Last Update Posted: September 28, 2023
• Last Verified: September 2023

• 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:

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