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

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.

Study Overview

• Status: Recruiting
• Conditions: Neoplasms; Quality of Life; Breast Cancer; Head and Neck Cancer; Head and Neck Neoplasms; Gynecologic Cancer; Liver Neoplasms; Pancreatic Neoplasms; Pancreatic Cancer; Esophageal Cancer; Lung Cancer; Rectal Cancer; Rectal Neoplasms; Prostate Cancer; Brain Cancer; Brain Tumor; Bladder Cancer; Liver Metastases; Tumor; Radiation Toxicity; Liver Cancer; Oncology; Prostate Neoplasm; Head and Neck Tumor; Oligometastases; Esophageal Neoplasm; Esophagus Cancer; Lung Neoplasm; Breast Tumor; Rectal Tumor; Pancreatic Tumor; Esophageal Tumor; Gynecologic Tumor; Prostate Tumor; Lung Tumor; Esophagus Tumor; Esophagus Neoplasm; Bladder Neoplasm
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Estimated): 8000

Contacts and Locations

• Study Contact: Name: Tessa Leer; Phone Number: T +31 (0)88 75 63707; Email: T.Leer@umcutrecht.nl

Study Locations

• Australia
  • Melbourne, Australia
    • Not yet recruiting
    • Austin Health - Olivia Newton-John Cancer Wellness and Research Centre
    • Contact: Sweet Ping
• Belgium
  • Brussel, Belgium
    • Not yet recruiting
    • Insitut Jules Bordet
    • Contact: Robbe van den Begin
• Canada
  • Toronto, Canada
    • Recruiting
    • University Health Network - Princess Margaret Cancer Center
    • Contact: Michael Velec
  • Ontario
    • Toronto, Ontario, Canada
      • Recruiting
      • Sunnybrook Health Sciences Centre/Odette Cancer Centre
      • Contact: Arjun Sahgal
• Denmark
  • Funen
    • Odense, Funen, Denmark, 5000
      • Recruiting
      • Odense Universitetshospital
      • Contact: Tine Schytte; Email: Tine.Schytte@rsyd.dk
• Germany
  • Tübingen, Germany
    • Recruiting
    • Universitätsklinikum Tübingen
    • Contact: Cihan Gani
• Italy
  • Brescia, Italy
    • Not yet recruiting
    • Università degli Studi di Brescia
    • Contact: Stefano Magrini
  • Negrar, Italy
    • Recruiting
    • IRCCS Ospedale Sacro Cuore Don Calabria
    • Contact: Filippo Alongi
• Netherlands
  • Amsterdam, Netherlands
    • Recruiting
    • Netherlands Cancer Institute, Antoni van Leeuwenhoek Hospital
    • Contact: Marlies N Nowee
  • Deventer, Netherlands
    • Recruiting
    • Radiotherapiegroep
    • Contact: Paul Jeene
  • Leeuwarden, Netherlands
    • Not yet recruiting
    • Radiotherapeutisch Instituut Friesland (RIF)
    • Contact: Peter de Boer
  • Nijmegen, Netherlands
    • Recruiting
    • Radboud UMC
    • Contact: Linda Kerkmeijer
  • Utrecht, Netherlands, 3508GA
    • Recruiting
    • University Medical Center Utrecht
    • Contact: Tessa Leer; Email: T.Leer@umcutrecht.nl
    • Sub-Investigator: Tessa Leer
    • Contact: Helena M Verkooijen, Prof, Dr; Email: h.m.verkooijen@umcutrecht.nl
    • Principal Investigator: Helena M Verkooijen, Prof, Dr
• United Kingdom
  • London, United Kingdom
    • Recruiting
    • The Royal Marsden and The Institute of Cancer Research National Institute for Health Research Biomedical Research Centre
    • Contact: Shaista Hafeez
  • Manchester, United Kingdom
    • Recruiting
    • The Christie National Health Service Foundation Trust
    • Contact: Ananya Choudhury
• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15212
      • Recruiting
      • Allegheny Health Network
      • Contact: Tom Colonias
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • MD Anderson Cancer Center
      • Contact: Clifton D Fuller; Phone Number: 713-745-4404; Email: cdfuller@mdanderson.org
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Recruiting
      • Medical College of Wisconsin
      • Contact: William A Hall

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• 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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

13

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Lung cancer	Radiation: Radiation therapy; Radiation therapy on the CE marked and FDA approved MR-Linac
Brain 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

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

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2019
• Primary Completion (Estimated): February 1, 2024
• Study Completion (Estimated): May 1, 2025

Study Registration Dates

• First Submitted: March 22, 2019
• First Submitted That Met QC Criteria: August 28, 2019
• First Posted (Actual): August 30, 2019

Study Record Updates

• Last Update Posted (Actual): September 28, 2023
• Last Update Submitted That Met QC Criteria: September 25, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Skin Diseases; Respiratory Tract Diseases; Lung Diseases; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Urologic Diseases; Urinary Bladder Diseases; Endocrine System Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Endocrine Gland Neoplasms; Genital Neoplasms, Male; Breast Diseases; Liver Diseases; Prostatic Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Central Nervous System Neoplasms; Nervous System Neoplasms; Esophageal Diseases; Colorectal Neoplasms; Pancreatic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Genital Diseases, Female; Neoplasms; Breast Neoplasms; Head and Neck Neoplasms; Prostatic Neoplasms; Lung Neoplasms; Urinary Bladder Neoplasms; Rectal Neoplasms; Brain Neoplasms; Pancreatic Neoplasms; Liver Neoplasms; Genital Neoplasms, Female; Esophageal Neoplasms
• Other Study ID Numbers: NL66650.041.18

Drug and device information, study documents

• 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