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Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Observational [Patient Registry]|
|Eligible Ages||18 Years and Over|
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Helena M Verkooijen, Prof, Dr|
|Principal Investigator Affiliation||Universitair Medical Centre Utrecht|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
|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|
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.
: Brain cancer
: Lung cancer
: Esophageal cancer
: Breast Cancer
: Head and Neck Cancer
: Pancreatic cancer
: Gynecological cancer
: Rectal cancer
: Prostate cancer
: Bladder cancer
: Liver cancer
: Other types of cancer
Radiation: - Radiation therapy
Radiation therapy on the CE marked and FDA approved MR-Linac
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.