Abstract Details

Title Challenges in Deploying Low-Field and Ultra-Low Field MRI in Research, Clinical Care, Population Screening, and Direct-to-Consumer Use

Topic Practice, Policy, and Ethics

Presentation(s) P15 - Poster Session 15 (5:30 PM-6:30 PM)

Poster/Presentation
Number 1-001

Background

LF and ULF MRI technologies are already being used in some clinical care, clinical research, and field-based international research. But LF and ULF MRI differ from fixed high-field MRI in key technical respects, raising questions about their appropriate uses and the adequacy of existing guidance.

Objective

Innovations in low-field (LF) and ultra-low field (ULF) magnetic resonance imaging (MRI) technology are revolutionizing brain MRI by making it more portable and accessible, while lowering cost. The objectives of this NIH-funded study (RF1MH123698) are: (1) to identify expected uses for these new technologies across research, clinical care, population screening, and direct-to-consumer (DTC) use; and (2) by identifying the ethical and legal standards that apply in those four contexts, to analyze and propose solutions for core ethical, legal, and societal implications (ELSI) challenges.

Design/Methods

To identify expected uses, ELSI challenges, and potential solutions, we formed an interdisciplinary Working Group (WG) with expertise in neuroimaging, neurology, radiology, psychiatry, neuroscience, health disparities, artificial intelligence, bioethics/neuroethics, and law. As part of the NIH BRAIN Initiative, the WG is engaged in a multi-year process, including using a modified Delphi methodology, literature reviews, consultation with outside experts, and multiple survey inputs, plus dialogic bioethics consensus methods, to generate normative recommendations.

Results

The preliminary results of the study identify critical unanswered questions related to seven key ELSI challenges: (A) safety and security; (B) validity; (C) equity and health disparities; (D) training protocols; (E) combination with technologies such as AI/ML to produce and remotely communicate the MRI images; and (F) ethics of marketing these technologies, including for DTC use.

Conclusions

This early analysis of the role of LF and ULF brain MRI and associated challenges will guide and optimize development and deployment of this important set of new technologies by clinicians and researchers in the neurosciences.

Authors/Disclosures
Francis X. Shen, PhD, JD PRESENTER	The institution of Dr. Shen has received research support from National Institutes of Health. The institution of Dr. Shen has received research support from Dana Foundation.
	No disclosure on file
	No disclosure on file
	No disclosure on file
Judy Illes, PhD, CM (UBC, Div of Neurology, Dept Medicine)	Dr. Illes has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Stanford University. Dr. Illes has received personal compensation in the range of $5,000-$9,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Elsevier Press. The institution of Dr. Illes has received research support from NIH, CIHR, Technical Safety BC, WorkSafeBC, North Growth Foundation, FRQ. Dr. Illes has received publishing royalties from a publication relating to health care. Dr. Illes has a non-compensated relationship as a Distinguished University Professor and Distinguished Professor in Neuroethics with University of British Columbia that is relevant to AAN interests or activities.
W. T. Kimberly, MD, PhD (Massachusetts General Hospital)	Dr. Kimberly has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Astrocyte Pharmaceuticals. Dr. Kimberly has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Acasti Pharma. Dr. Kimberly has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Hyperfine Inc.. Dr. Kimberly has received personal compensation in the range of $500-$4,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Neurotherapeutics. Dr. Kimberly has stock in Woolsey Pharmaceuticals. Dr. Kimberly has stock in Acasti Pharma. The institution of Dr. Kimberly has received research support from Biogen. The institution of Dr. Kimberly has received research support from NControl Therapeutics. The institution of Dr. Kimberly has received research support from NIH. The institution of Dr. Kimberly has received research support from American Heart Association. The institution of Dr. Kimberly has received research support from Hyperfine, Inc.. Dr. Kimberly has received intellectual property interests from a discovery or technology relating to health care.
Eran P. Klein, MD, PhD (Portland VA Health Care System)	The institution of Dr. Klein has received research support from NIH.
	No disclosure on file
Matthew Rosen	No disclosure on file
Kevin N. Sheth, MD, FAAN (Yale UniversityDivision of Neuro and Critical Care)	Dr. Sheth has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Ceribell. Dr. Sheth has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Zoll. Dr. Sheth has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for NControl. Dr. Sheth has received stock or an ownership interest from Astrocyte. Dr. Sheth has received stock or an ownership interest from Alva. The institution of Dr. Sheth has received research support from Biogen. The institution of Dr. Sheth has received research support from Novartis. The institution of Dr. Sheth has received research support from Bard. The institution of Dr. Sheth has received research support from Hyperfine. Dr. Sheth has received intellectual property interests from a discovery or technology relating to health care.
	No disclosure on file
Paul J. Tuite, MD, FAAN (University of Minnesota)	The institution of Dr. Tuite has received research support from NIH. The institution of Dr. Tuite has received research support from NIH. The institution of Dr. Tuite has received research support from NIH. The institution of Dr. Tuite has received research support from Bristol-Myers Squibb.
John T. Vaughan, Jr., PhD (Columbia University)	Prof. Vaughan has received personal compensation in the range of $500-$4,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for John Wiley. The institution of Prof. Vaughan has received research support from NIH. The institution of Prof. Vaughan has received research support from NSF.