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

UMC Utrecht

Status: Enrolling

Conditions: Oligometastases; Prostate Neoplasm; Esophageal Cancer; Esophageal Tumor; Tumor; Head and Neck Neoplasms; Liver Cancer; Bladder Cancer; Quality of Life; Liver Neoplasms; Pancreatic Tumor; Rectal Tumor; Rectal Neoplasms; Pancreatic Cancer; Esophagus Cancer; Breast Cancer; Oncology; Radiation Toxicity; Esophagus Tumor; Prostate Tumor; Brain Tumor; Liver Metastases; Lung Cancer; Lung Neoplasm; Breast Tumor; Gynecologic Tumor; Esophagus Neoplasm; Brain Cancer; Bladder Neoplasm; Neoplasms; Lung Tumor; Gynecologic Cancer; Esophageal Neoplasm; Head and Neck Cancer; Prostate Cancer; Head and Neck Tumor; Pancreatic Neoplasms; Rectal Cancer

Treatments: Radiation: Radiation therapy

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT04075305

NL66650.041.18

Details and patient eligibility

About

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.

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.

Enrollment: 8,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 design

8,000 participants in 13 patient groups

Brain cancer

Treatment:

Radiation: Radiation therapy

Lung cancer

Treatment:

Radiation: Radiation therapy

Esophageal cancer

Treatment:

Radiation: Radiation therapy

Breast Cancer

Treatment:

Radiation: Radiation therapy

Head and Neck Cancer

Treatment:

Radiation: Radiation therapy

Pancreatic cancer

Treatment:

Radiation: Radiation therapy

Gynecological cancer

Treatment:

Radiation: Radiation therapy

Rectal cancer

Treatment:

Radiation: Radiation therapy

Prostate cancer

Treatment:

Radiation: Radiation therapy

Bladder cancer

Treatment:

Radiation: Radiation therapy

Oligometastases

Treatment:

Radiation: Radiation therapy

Liver cancer

Treatment:

Radiation: Radiation therapy

Other types of cancer

Treatment:

Radiation: Radiation therapy