Breast Cancer Clinical Trial

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

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.

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Full 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.

View Eligibility Criteria

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 is for people with:

Breast Cancer

Estimated Enrollment:

8000

Study ID:

NCT04075305

Recruitment Status:

Recruiting

Sponsor:

UMC Utrecht

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There are 5 Locations for this study

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Allegheny Health Network
Pittsburgh Pennsylvania, 15212, United States More Info
Tom Colonias
Contact
Md Anderson Cancer Center
Houston Texas, 77030, United States More Info
Clifton D Fuller
Contact
713-745-4404
[email protected]
Medical College of Wisconsin
Milwaukee Wisconsin, 53226, United States More Info
William A Hall
Contact
Austin Health - Olivia Newton-John Cancer Wellness and Research Centre
Melbourne , , Australia More Info
Sweet Ping
Contact
Insitut Jules Bordet
Brussel , , Belgium More Info
Robbe van den Begin
Contact
Sunnybrook Health Sciences Centre/Odette Cancer Centre
Toronto Ontario, , Canada More Info
Arjun Sahgal
Contact
University Health Network - Princess Margaret Cancer Center
Toronto , , Canada More Info
Michael Velec
Contact
Odense Universitetshospital
Odense Funen, 5000, Denmark More Info
Tine Schytte
Contact
[email protected]
Universitätsklinikum Tübingen
Tübingen , , Germany More Info
Cihan Gani
Contact
Università degli Studi di Brescia
Brescia , , Italy More Info
Stefano Magrini
Contact
IRCCS Ospedale Sacro Cuore Don Calabria
Negrar , , Italy More Info
Filippo Alongi
Contact
Netherlands Cancer Institute, Antoni van Leeuwenhoek Hospital
Amsterdam , , Netherlands More Info
Marlies N Nowee
Contact
Radiotherapiegroep
Deventer , , Netherlands More Info
Paul Jeene
Contact
Radiotherapeutisch Instituut Friesland (RIF)
Leeuwarden , , Netherlands More Info
Peter de Boer
Contact
Radboud UMC
Nijmegen , , Netherlands More Info
Linda Kerkmeijer
Contact
University Medical Center Utrecht
Utrecht , 3508G, Netherlands More Info
Helena M Verkooijen, Prof, Dr
Contact
[email protected]
Tessa Leer
Contact
[email protected]
Tessa Leer
Sub-Investigator
Helena M Verkooijen, Prof, Dr
Principal Investigator
The Royal Marsden and The Institute of Cancer Research National Institute for Health Research Biomedical Research Centre
London , , United Kingdom More Info
Shaista Hafeez
Contact
The Christie National Health Service Foundation Trust
Manchester , , United Kingdom More Info
Ananya Choudhury
Contact

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Estimated Enrollment:

8000

Study ID:

NCT04075305

Recruitment Status:

Recruiting

Sponsor:


UMC Utrecht

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