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

NCT ID: NCT04075305

Last Updated: 2023-09-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

8000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-02-01

Study Completion Date

2025-05-01

Brief Summary

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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

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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.

Conditions

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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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Brain cancer

Radiation therapy

Intervention Type RADIATION

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

Lung cancer

Radiation therapy

Intervention Type RADIATION

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

Esophageal cancer

Radiation therapy

Intervention Type RADIATION

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

Breast Cancer

Radiation therapy

Intervention Type RADIATION

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

Head and Neck Cancer

Radiation therapy

Intervention Type RADIATION

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

Pancreatic cancer

Radiation therapy

Intervention Type RADIATION

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

Gynecological cancer

Radiation therapy

Intervention Type RADIATION

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

Rectal cancer

Radiation therapy

Intervention Type RADIATION

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

Prostate cancer

Radiation therapy

Intervention Type RADIATION

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

Bladder cancer

Radiation therapy

Intervention Type RADIATION

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

Oligometastases

Radiation therapy

Intervention Type RADIATION

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

Liver cancer

Radiation therapy

Intervention Type RADIATION

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

Other types of cancer

Radiation therapy

Intervention Type RADIATION

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

Interventions

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Radiation therapy

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

Intervention Type RADIATION

Eligibility Criteria

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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 contraindications as per usual clinical care, such as (possible) pregnancy; claustrophobia and metal or electronic implants not compatible with MRI.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Netherlands Cancer Institute

OTHER

Sponsor Role collaborator

Sunnybrook Health Sciences Centre

OTHER

Sponsor Role collaborator

M.D. Anderson Cancer Center

OTHER

Sponsor Role collaborator

The Christie NHS Foundation Trust

OTHER

Sponsor Role collaborator

Royal Marsden NHS Foundation Trust

OTHER

Sponsor Role collaborator

Medical College of Wisconsin

OTHER

Sponsor Role collaborator

Elekta Limited

INDUSTRY

Sponsor Role collaborator

Odense University Hospital

OTHER

Sponsor Role collaborator

Radboud University Medical Center

OTHER

Sponsor Role collaborator

Radiotherapiegroep

OTHER

Sponsor Role collaborator

Jules Bordet Institute

OTHER

Sponsor Role collaborator

University Hospital Tuebingen

OTHER

Sponsor Role collaborator

Radiotherapeutic Institute Friesland

OTHER

Sponsor Role collaborator

Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)

OTHER

Sponsor Role collaborator

IRCCS Sacro Cuore Don Calabria di Negrar

OTHER

Sponsor Role collaborator

Austin Health

OTHER_GOV

Sponsor Role collaborator

Princess Margaret Hospital, Canada

OTHER

Sponsor Role collaborator

Università degli Studi di Brescia

OTHER

Sponsor Role collaborator

UMC Utrecht

OTHER

Sponsor Role lead

Responsible Party

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Helena M Verkooijen

Prof. Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Helena M Verkooijen, Prof, Dr

Role: PRINCIPAL_INVESTIGATOR

Universitair Medical Centre Utrecht

Locations

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Allegheny Health Network

Pittsburgh, Pennsylvania, United States

Site Status RECRUITING

Md Anderson Cancer Center

Houston, Texas, United States

Site Status RECRUITING

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Site Status RECRUITING

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

Melbourne, , Australia

Site Status NOT_YET_RECRUITING

Insitut Jules Bordet

Brussels, , Belgium

Site Status NOT_YET_RECRUITING

Sunnybrook Health Sciences Centre/Odette Cancer Centre

Toronto, Ontario, Canada

Site Status RECRUITING

University Health Network - Princess Margaret Cancer Center

Toronto, , Canada

Site Status RECRUITING

Odense Universitetshospital

Odense, Funen, Denmark

Site Status RECRUITING

Universitätsklinikum Tübingen

Tübingen, , Germany

Site Status RECRUITING

Università degli Studi di Brescia

Brescia, , Italy

Site Status NOT_YET_RECRUITING

IRCCS Ospedale Sacro Cuore Don Calabria

Negrar, , Italy

Site Status RECRUITING

Netherlands Cancer Institute, Antoni van Leeuwenhoek Hospital

Amsterdam, , Netherlands

Site Status RECRUITING

Radiotherapiegroep

Deventer, , Netherlands

Site Status RECRUITING

Radiotherapeutisch Instituut Friesland (RIF)

Leeuwarden, , Netherlands

Site Status NOT_YET_RECRUITING

Radboud UMC

Nijmegen, , Netherlands

Site Status RECRUITING

University Medical Center Utrecht

Utrecht, , Netherlands

Site Status RECRUITING

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

London, , United Kingdom

Site Status RECRUITING

The Christie National Health Service Foundation Trust

Manchester, , United Kingdom

Site Status RECRUITING

Countries

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United States Australia Belgium Canada Denmark Germany Italy Netherlands United Kingdom

Central Contacts

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Tessa Leer

Role: CONTACT

T +31 (0)88 75 63707

Facility Contacts

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Tom Colonias

Role: primary

Clifton D Fuller

Role: primary

713-745-4404

William A Hall

Role: primary

Sweet Ping

Role: primary

Robbe van den Begin

Role: primary

Arjun Sahgal

Role: primary

Michael Velec

Role: primary

Tine Schytte

Role: primary

Cihan Gani

Role: primary

Stefano Magrini

Role: primary

Filippo Alongi

Role: primary

Marlies N Nowee

Role: primary

Paul Jeene

Role: primary

Peter de Boer

Role: primary

Linda Kerkmeijer

Role: primary

Helena M Verkooijen, Prof, Dr

Role: primary

Tessa Leer

Role: backup

Shaista Hafeez

Role: primary

Ananya Choudhury

Role: primary

References

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Tan H, Stewart J, Ruschin M, Wang MH, Myrehaug S, Tseng CL, Detsky J, Husain Z, Chen H, Sahgal A, Soliman H. Inter-fraction dynamics during post-operative 5 fraction cavity hypofractionated stereotactic radiotherapy with a MR LINAC: a prospective serial imaging study. J Neurooncol. 2022 Feb;156(3):569-577. doi: 10.1007/s11060-021-03938-w. Epub 2022 Jan 3.

Reference Type DERIVED
PMID: 34981300 (View on PubMed)

de Mol van Otterloo SR, Christodouleas JP, Blezer ELA, Akhiat H, Brown K, Choudhury A, Eggert D, Erickson BA, Faivre-Finn C, Fuller CD, Goldwein J, Hafeez S, Hall E, Harrington KJ, van der Heide UA, Huddart RA, Intven MPW, Kirby AM, Lalondrelle S, McCann C, Minsky BD, Mook S, Nowee ME, Oelfke U, Orrling K, Sahgal A, Sarmiento JG, Schultz CJ, Tersteeg RJHA, Tijssen RHN, Tree AC, van Triest B, Hall WA, Verkooijen HM. The MOMENTUM Study: An International Registry for the Evidence-Based Introduction of MR-Guided Adaptive Therapy. Front Oncol. 2020 Sep 7;10:1328. doi: 10.3389/fonc.2020.01328. eCollection 2020.

Reference Type DERIVED
PMID: 33014774 (View on PubMed)

Other Identifiers

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NL66650.041.18

Identifier Type: -

Identifier Source: org_study_id

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