The MOMENTUM Study: The Multiple Outcome Evaluation of Radiation Therapy Using the MR-Linac Study
Status
RECRUITING
Phase
Age
≥ 18 Years
Enrollments
8000Conditions
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, OligometastasesSummary
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.
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.
Locations
3 locations Found with status Recruiting
Status
- RECRUITING
Contact Person
- Tom Colonias
Principal Investigator
- Helena M Verkooijen, Prof, Dr
Status
- RECRUITING
Contact Person
- Clifton D Fuller
- 713-745-4404
- [email protected]
Principal Investigator
- Helena M Verkooijen, Prof, Dr
Status
- RECRUITING
Contact Person
- William A Hall
Principal Investigator
- Helena M Verkooijen, Prof, Dr
Eligibility 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.
Study Plan
Brain cancer
RADIATION:
Radiation therapyDescription:
Radiation therapy on the CE marked and FDA approved MR-Linac
Lung cancer
RADIATION:
Radiation therapyDescription:
Radiation therapy on the CE marked and FDA approved MR-Linac
Esophageal cancer
RADIATION:
Radiation therapyDescription:
Radiation therapy on the CE marked and FDA approved MR-Linac
Breast Cancer
RADIATION:
Radiation therapyDescription:
Radiation therapy on the CE marked and FDA approved MR-Linac
Head and Neck Cancer
RADIATION:
Radiation therapyDescription:
Radiation therapy on the CE marked and FDA approved MR-Linac
Pancreatic cancer
RADIATION:
Radiation therapyDescription:
Radiation therapy on the CE marked and FDA approved MR-Linac
Gynecological cancer
RADIATION:
Radiation therapyDescription:
Radiation therapy on the CE marked and FDA approved MR-Linac
Rectal cancer
RADIATION:
Radiation therapyDescription:
Radiation therapy on the CE marked and FDA approved MR-Linac
Prostate cancer
RADIATION:
Radiation therapyDescription:
Radiation therapy on the CE marked and FDA approved MR-Linac
Bladder cancer
RADIATION:
Radiation therapyDescription:
Radiation therapy on the CE marked and FDA approved MR-Linac
Oligometastases
RADIATION:
Radiation therapyDescription:
Radiation therapy on the CE marked and FDA approved MR-Linac
Liver cancer
RADIATION:
Radiation therapyDescription:
Radiation therapy on the CE marked and FDA approved MR-Linac
Other types of cancer
RADIATION:
Radiation therapyDescription:
Radiation therapy on the CE marked and FDA approved MR-Linac
Outcome Measures
Primary Outcome Measures
Progression-free Survival
Progression-free Survival
Progression-free Survival
Survival
Survival
Survival
Disease-free Survival
Disease-free Survival
Disease-free Survival
Patient reported Health related quality of life (HRQoL).
Patient reported Health related quality of life (HRQoL).
Patient reported Health related quality of life (HRQoL).
Patient reported Health related quality of life (HRQoL).
Patient reported Health related quality of life (HRQoL).
Patient reported Health related quality of life (HRQoL).
Patient reported Health related quality of life (HRQoL).
Patient reported Health related quality of life (HRQoL).
Patient reported tumor specific quality of life (QoL).
Patient reported tumor specific quality of life (QoL).
Patient reported tumor specific quality of life (QoL).
Patient reported tumor specific quality of life (QoL).
Acute toxicity in common toxicity criteria for adverse events (CTCAE).
Acute toxicity in common toxicity criteria for adverse events (CTCAE).
Acute toxicity in common toxicity criteria for adverse events (CTCAE).
Acute toxicity in common toxicity criteria for adverse events (CTCAE).
Clinical tumor response.
Pathological tumor response.
Toxicity in common toxicity criteria for adverse events (CTCAE).
Timeline
Last Updated
September 28, 2023Start Date
August 30, 2019Today
February 5, 2025Completion Date ( Estimated )
May 1, 2025
Sponsors of this trial
Lead Sponsor
UMC UtrechtCollaborating Sponsors
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
RECRUITING 
21 - 64 Years