Protocol development for a Hyperfine Very Low Field (0.064 T)
MRI system

Very low-field (<0.1 T) portable MRI scanners are emerging as a new category of
systems with much lower costs than conventional systems and the ability to be
used in sites and applications where conventional MRI is impossible. In spring
2022 the LUMC Department of Radiology, in collaboration with the Gates
Foundation, obtained a Hyperfine Swoop 0.064 T portable MRI scanner. The
purpose of our collaboration is to perform MRI-protocol development to optimize
image contrast in the brain using a number of different MRI techniques. Since
MR parameters are much less studied at very low field than at conventional
clinical field strengths, this will involve measuring each MR parameter in a
number of healthy volunteers to derive optimized parameters and show that image
contrast is improved compared to existing techniques on the system.
Dissemination of findings will be performed via articles in world leading
journals on MR techniques. Such developments and publication of results are
common to the MR community, and lead to a continuous development and
improvement of the capabilities of MR scanners.

Our overall aim is to measure several distinct MR parameters at 0.064 Tesla,
and to use these to derive optimal MRI-protocols in terms of contrast and SNR.
Some of these new developments may subsequently be used in clinical research
protocols (which are not a part of this protocol), other developments are more
fundamental technical MR developments for which applications will only benefit
in the future.

We note that there will be no data collection for medical research. Only
projects aiming at the development, optimization and/or interpretation of
non-invasive MR techniques are included. MRI-protocol development will follow
the usual roadmap of MR physics research that consists of an iterative process
of identification of new requirements or artefacts in existing techniques,
MRI-protocol optimization, sequence development, pilot experiments, quality
review meetings, and finally back to identification of sources of artefacts.
For 6 different MR contrast mechanisms, we will scan 20 healthy volunteers
(total number=120) to evaluate the consequent optimisation of Signal-to-Noise
Ratio (SNR) and Contrast-to-Noise Ratio (CNR) and to publish results of these
new protocols/sequences.

All of the issues concerning safety and risk at 0.064 T are hundreds/thousands
of times lower than the corresponding considerations at clinical MRI field
strengths (1.5 and 3T), further details can be found in the risk and analysis
sections of the attached IMDD. Although the Hyperfine Swoop currently does not
have a CE mark, it was FDA approved in 2020 and so has been extensively tested
with respect to safety and risk/benefit.
26-07-2022