Laying the groundwork for qMRI device comparability
Magnetic resonance imaging (MRI) combines strong magnetic fields and radio waves to produce detailed internal imaging without exposing patients to ionising radiation. Europe’s health services use a variety of MRI technologies to diagnose and monitor conditions including cancer, heart disease, dementia, and strokes. Several recent devices offer Quantitative MRI (qMRI) as a feature, proposing to measure physical or chemical properties indicative of disease progression or remission, or the effects of therapies in subjects for clinical trials. However, with no independent validation method able to ensure accuracy, or any requirements in standards to validate devices on the market, the potential benefits are not fully exploitable. Phantoms, that model human physiology, are produced to calibrate MRI devices, but current products are insufficiently accurate or unsuited to qMRI, while no formal best-practice advice exists.
To support clinical uptake, the project will develop procedures and guidance, and initiate standardisation of qMRI. Candidate phantom materials and new manufacturing processes will be developed, where possible traceable to reference materials and primary standards, and calibration methods compared. These outputs will inform the writing of a best practice guide, to be tested in a multi-site study involving the diagnosis and treatment of a liver condition, and then repackaged as a quality assurance Good Practice Guide (CPG). Similarly, guidance will be developed for simulating phantoms in software and on uncertainty quantification for qMRI procedures. The resulting calibration methods and GPG will enable the assessment of devices in longitudinal studies, and the GPG will be the basis of a proposed international standard. Ultimately, independent validation of qMRI measurements and standards will reduce the cost and complexity of patient studies and lower barriers to developing new therapies.