The Multi-OutcoMe EvaluatioN of radiation Therapy Using the MR-Linac Study (MOMENTUM) aims to accelerate the technical and clinical development of Anatomic and Functional MRGRT and facilitate the evidence-based introduction of the MR-Linac into…
ID
Source
Brief title
Condition
- Miscellaneous and site unspecified neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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.
Secondary outcome
NA
Background summary
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.
Study 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 Functional 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 functional MR sequences to
develop new features. Furthermore, the cohort will provide the logistics for
future intervention studies according to the TwiCs design. This enables
efficient hypothesis testing with a comparable reference population from the
same cohort. The MOMENTUM cohort study is expected to enable optimal radiation
treatment approach to improve patients* survival, local, and regional tumor
control and quality of life.
Study design
A multi-institutional, international observational cohort study with the option
for intervention studies possibly according to the TwiCs design.
Study burden and risks
No benefits are expected for the participants.
No risks are known for patients undergoing research MRI, since they will be
screened according to the MRI safety criteria. The risk of breach of privacy
and confidentiality will be managed by strict adherence to data safety and
security procedures.
Heidelberglaan 100
Utrecht 3584 CX
NL
Heidelberglaan 100
Utrecht 3584 CX
NL
Listed location countries
Age
Inclusion criteria
In order to be eligible to participate in this study, a subject must meet all
of the following criteria:
- Patient is to undergo or has completed imaging or is eligable for 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;
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL66650.041.18 |