Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04075305
Other study ID # NL66650.041.18
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date February 1, 2019
Est. completion date May 1, 2025

Study information

Verified date September 2023
Source UMC Utrecht
Contact Tessa Leer
Phone T +31 (0)88 75 63707
Email T.Leer@umcutrecht.nl
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 8000
Est. completion date May 1, 2025
Est. primary completion date February 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms

  • Bladder Cancer
  • Bladder Neoplasm
  • Brain Cancer
  • Brain Neoplasms
  • Brain Tumor
  • Breast Cancer
  • Breast Neoplasms
  • Breast Tumor
  • Esophageal Cancer
  • Esophageal Neoplasm
  • Esophageal Neoplasms
  • Esophageal Tumor
  • Esophagus Cancer
  • Esophagus Neoplasm
  • Esophagus Tumor
  • Genital Neoplasms, Female
  • Gynecologic Cancer
  • Gynecologic Tumor
  • Head and Neck Cancer
  • Head and Neck Neoplasms
  • Head and Neck Tumor
  • Liver Cancer
  • Liver Metastases
  • Liver Neoplasms
  • Lung Cancer
  • Lung Neoplasm
  • Lung Neoplasms
  • Lung Tumor
  • Neoplasms
  • Oligometastases
  • Oncology
  • Pancreatic Cancer
  • Pancreatic Neoplasms
  • Pancreatic Tumor
  • Prostate Cancer
  • Prostate Neoplasm
  • Prostate Tumor
  • Prostatic Neoplasms
  • Quality of Life
  • Radiation Toxicity
  • Rectal Cancer
  • Rectal Neoplasms
  • Rectal Tumor
  • Tumor
  • Urinary Bladder Neoplasms

Intervention

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

Locations

Country Name City State
Australia Austin Health - Olivia Newton-John Cancer Wellness and Research Centre Melbourne
Belgium Insitut Jules Bordet Brussel
Canada Sunnybrook Health Sciences Centre/Odette Cancer Centre Toronto Ontario
Canada University Health Network - Princess Margaret Cancer Center Toronto
Denmark Odense Universitetshospital Odense Funen
Germany Universitätsklinikum Tübingen Tübingen
Italy Università degli Studi di Brescia Brescia
Italy IRCCS Ospedale Sacro Cuore Don Calabria Negrar
Netherlands Netherlands Cancer Institute, Antoni van Leeuwenhoek Hospital Amsterdam
Netherlands Radiotherapiegroep Deventer
Netherlands Radiotherapeutisch Instituut Friesland (RIF) Leeuwarden
Netherlands Radboud UMC Nijmegen
Netherlands University Medical Center Utrecht Utrecht
United Kingdom The Royal Marsden and The Institute of Cancer Research National Institute for Health Research Biomedical Research Centre London
United Kingdom The Christie National Health Service Foundation Trust Manchester
United States Md Anderson Cancer Center Houston Texas
United States Medical College of Wisconsin Milwaukee Wisconsin
United States Allegheny Health Network Pittsburgh Pennsylvania

Sponsors (19)

Lead Sponsor Collaborator
UMC Utrecht 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, Università degli Studi di Brescia, University Hospital Tuebingen

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Canada,  Denmark,  Germany,  Italy,  Netherlands,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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.
Primary 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.
Primary 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.
Primary 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.
Primary 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.
Primary 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.
Primary 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.
Primary 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.
Primary 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.
Primary 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.
Primary 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.
Primary 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.
Primary 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.
Primary 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.
Primary 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.
Primary 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.
Primary 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.
Primary 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.
Primary Toxicity in common toxicity criteria for adverse events (CTCAE). Disease-specific toxicity is obtained from the hospital information system. 2 years
See also
  Status Clinical Trial Phase
Recruiting NCT04681911 - Inetetamab Combined With Pyrotinib and Chemotherapy in the Treatment of HER2 Positive Metastatic Breast Cancer Phase 2
Terminated NCT04066790 - Pyrotinib or Trastuzumab Plus Nab-paclitaxel as Neoadjuvant Therapy in HER2-positive Breast Cancer Phase 2
Completed NCT04890327 - Web-based Family History Tool N/A
Completed NCT03591848 - Pilot Study of a Web-based Decision Aid for Young Women With Breast Cancer, During the Proposal for Preservation of Fertility N/A
Recruiting NCT03954197 - Evaluation of Priming Before in Vitro Maturation for Fertility Preservation in Breast Cancer Patients N/A
Terminated NCT02202746 - A Study to Assess the Safety and Efficacy of the VEGFR-FGFR-PDGFR Inhibitor, Lucitanib, Given to Patients With Metastatic Breast Cancer Phase 2
Active, not recruiting NCT01472094 - The Hurria Older PatiEnts (HOPE) With Breast Cancer Study
Withdrawn NCT06057636 - Hypnosis for Pain in Black Women With Advanced Breast Cancer: A Feasibility Study N/A
Completed NCT06049446 - Combining CEM and Magnetic Seed Localization of Non-Palpable Breast Tumors
Recruiting NCT05560334 - A Single-Arm, Open, Exploratory Clinical Study of Pemigatinib in the Treatment of HER2-negative Advanced Breast Cancer Patients With FGFR Alterations Phase 2
Active, not recruiting NCT05501769 - ARV-471 in Combination With Everolimus for the Treatment of Advanced or Metastatic ER+, HER2- Breast Cancer Phase 1
Recruiting NCT04631835 - Phase I Study of the HS-10352 in Patients With Advanced Breast Cancer Phase 1
Completed NCT04307407 - Exercise in Breast Cancer Survivors N/A
Recruiting NCT03544762 - Correlation of 16α-[18F]Fluoro-17β-estradiol PET Imaging With ESR1 Mutation Phase 3
Terminated NCT02482389 - Study of Preoperative Boost Radiotherapy N/A
Enrolling by invitation NCT00068003 - Harvesting Cells for Experimental Cancer Treatments
Completed NCT00226967 - Stress, Diurnal Cortisol, and Breast Cancer Survival
Recruiting NCT06006390 - CEA Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of CEA Positive Advanced Solid Tumors Phase 1/Phase 2
Recruiting NCT06037954 - A Study of Mental Health Care in People With Cancer N/A
Recruiting NCT06019325 - Rhomboid Intercostal Plane Block on Chronic Pain Incidence and Acute Pain Scores After Mastectomy N/A