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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

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
Gender All
More Inclusion & Exclusion 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.

Trial Details

Trial ID:

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.

NCT04075305
Phase

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.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

UMC Utrecht
Principal Investigator

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
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other, Industry
Overall Status Recruiting
Countries Australia, Belgium, Canada, Denmark, Germany, Italy, Netherlands, United Kingdom, United States
Conditions

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
Additional Details

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.

Arms & Interventions

Arms

: Brain cancer

: Lung cancer

: Esophageal cancer

: Breast Cancer

: Head and Neck Cancer

: Pancreatic cancer

: Gynecological cancer

: Rectal cancer

: Prostate cancer

: Bladder cancer

: Oligometastases

: Liver cancer

: Other types of cancer

Interventions

Radiation: - Radiation therapy

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

Contact a Trial Team

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.

Allegheny Health Network, Pittsburgh, Pennsylvania

Status

Recruiting

Address

Allegheny Health Network

Pittsburgh, Pennsylvania, 15212

Site Contact

Tom Colonias

[email protected]

T +31 (0)88 75 63707

Md Anderson Cancer Center, Houston, Texas

Status

Recruiting

Address

Md Anderson Cancer Center

Houston, Texas, 77030

Site Contact

Clifton D Fuller

[email protected]

713-745-4404

Medical College of Wisconsin, Milwaukee, Wisconsin

Status

Recruiting

Address

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226

Site Contact

William A Hall

[email protected]

T +31 (0)88 75 63707

International Sites

Melbourne, Australia

Status

Not yet recruiting

Address

Austin Health - Olivia Newton-John Cancer Wellness and Research Centre

Melbourne, ,

Site Contact

Sweet Ping

[email protected]

T +31 (0)88 75 63707

Insitut Jules Bordet, Brussel, Belgium

Status

Not yet recruiting

Address

Insitut Jules Bordet

Brussel, ,

Site Contact

Robbe van den Begin

[email protected]

T +31 (0)88 75 63707

Toronto, Ontario, Canada

Status

Recruiting

Address

Sunnybrook Health Sciences Centre/Odette Cancer Centre

Toronto, Ontario,

Site Contact

Arjun Sahgal

[email protected]

T +31 (0)88 75 63707

Toronto, Canada

Status

Recruiting

Address

University Health Network - Princess Margaret Cancer Center

Toronto, ,

Site Contact

Michael Velec

[email protected]

T +31 (0)88 75 63707

Odense Universitetshospital, Odense, Funen, Denmark

Status

Recruiting

Address

Odense Universitetshospital

Odense, Funen, 5000

Site Contact

Tine Schytte

[email protected]

T +31 (0)88 75 63707

Universitätsklinikum Tübingen, Tübingen, Germany

Status

Recruiting

Address

Universitätsklinikum Tübingen

Tübingen, ,

Site Contact

Cihan Gani

[email protected]

T +31 (0)88 75 63707

Università degli Studi di Brescia, Brescia, Italy

Status

Not yet recruiting

Address

Università degli Studi di Brescia

Brescia, ,

Site Contact

Stefano Magrini

[email protected]

T +31 (0)88 75 63707

IRCCS Ospedale Sacro Cuore Don Calabria, Negrar, Italy

Status

Recruiting

Address

IRCCS Ospedale Sacro Cuore Don Calabria

Negrar, ,

Site Contact

Filippo Alongi

[email protected]

T +31 (0)88 75 63707

Amsterdam, Netherlands

Status

Recruiting

Address

Netherlands Cancer Institute, Antoni van Leeuwenhoek Hospital

Amsterdam, ,

Site Contact

Marlies N Nowee

[email protected]

T +31 (0)88 75 63707

Radiotherapiegroep, Deventer, Netherlands

Status

Recruiting

Address

Radiotherapiegroep

Deventer, ,

Site Contact

Paul Jeene

[email protected]

T +31 (0)88 75 63707

Leeuwarden, Netherlands

Status

Not yet recruiting

Address

Radiotherapeutisch Instituut Friesland (RIF)

Leeuwarden, ,

Site Contact

Peter de Boer

[email protected]

T +31 (0)88 75 63707

Radboud UMC, Nijmegen, Netherlands

Status

Recruiting

Address

Radboud UMC

Nijmegen, ,

Site Contact

Linda Kerkmeijer

[email protected]

T +31 (0)88 75 63707

University Medical Center Utrecht, Utrecht, Netherlands

Status

Recruiting

Address

University Medical Center Utrecht

Utrecht, , 3508GA

Site Contact

Helena M Verkooijen, Prof, Dr

[email protected]

T +31 (0)88 75 63707

London, United Kingdom

Status

Recruiting

Address

The Royal Marsden and The Institute of Cancer Research National Institute for Health Research Biomedical Research Centre

London, ,

Site Contact

Shaista Hafeez

[email protected]

T +31 (0)88 75 63707

Manchester, United Kingdom

Status

Recruiting

Address

The Christie National Health Service Foundation Trust

Manchester, ,

Site Contact

Ananya Choudhury

[email protected]

T +31 (0)88 75 63707