Ethical, legal, and policy challenges in field-based neuroimaging research using emerging portable MRI technologies: guidance for investigators and for oversight.

Researchers are rapidly developing and deploying highly portable MRI technology to conduct field-based research. The new technology will widen access to include new investigators in remote and unconventional settings and will facilitate greater inclusion of rural, economically disadvantaged, and historically underrepresented populations. To address the ethical, legal, and societal issues raised by highly accessible and portable MRI, an interdisciplinary Working Group (WG) engaged in a multi-year structured process of analysis and consensus building, informed by empirical research on the perspectives of experts and the general public. This article presents the WG's consensus recommendations. These recommendations address technology quality control, design and oversight of research, including safety of research participants and others in the scanning environment, engagement of diverse participants, therapeutic misconception, use of artificial intelligence algorithms to acquire and analyze MRI data, data privacy and security, return of results and managing incidental findings, and research participant data access and control.

Development of a compact NMR system to measure pO2 in a tissue-engineered graft.

Cellular macroencapsulation devices, known as tissue engineered grafts (TEGs), enable the transplantation of allogeneic cells without the need for life-long systemic immunosuppression. Islet containing TEGs offer promise as a potential functional cure for type 1 diabetes. Previous research has indicated sustained functionality of implanted islets at high density in a TEG requires external supplementary oxygen delivery and an effective tool to monitor TEG oxygen levels. A proven oxygen-measurement approach employs a 19F oxygen probe molecule (a perfluorocarbon) implanted alongside therapeutic cells to enable oxygen- and temperature- dependent NMR relaxometry. Although the approach has proved effective, the clinical translation of 19F oxygen relaxometry for TEG monitoring will be limited by the current inaccessibility and high cost of MRI. Here, we report the development of an affordable, compact, and tabletop 19F NMR relaxometry system for monitoring TEG oxygenation. The system uses a 0.5 T Halbach magnet with a bore diameter (19 cm) capable of accommodating the human arm, a potential site of future TEG implantation. 19F NMR relaxometry was performed while controlling the temperature and oxygenation levels of a TEG using a custom-built perfusion setup. Despite the magnet's nonuniform field, a pulse sequence of broadband adiabatic full-passage pulses enabled accurate 19F longitudinal relaxation rate (R1) measurements in times as short as ∼2 min (R1 vs oxygen partial pressure and temperature (R2 > 0.98)). The estimated sensitivity of R1 to oxygen changes at 0.5 T was 1.62-fold larger than the sensitivity previously reported for 16.4 T. We conclude that TEG oxygenation monitoring with a compact, tabletop 19F NMR relaxometry system appears feasible.

Fast spin-echo approach for accelerated B1 gradient-based MRI.

PURPOSE: To expand on the previously developed B 1 + $$ {\mathrm{B}}_1^{+} $$ -encoding technique, frequency-modulated Rabi-encoded echoes (FREE), to perform accelerated image acquisition by collecting multiple lines of k-space in an echo train. METHODS: FREE uses adiabatic full-passage pulses and a spatially varying RF field to encode unique spatial information without the use of traditional B0 gradients. The original implementation relied on acquiring single lines of k-space, leading to long acquisitions. In this work, an acceleration scheme is presented in which multiple echoes are acquired in a single shot, analogous to conventional fast spin-echo sequences. Theoretical analysis and computer simulations investigated the feasibility of this approach and presented a framework to analyze important imaging parameters of FREE-based sequences. Experimentally, the multi-echo approach was compared with conventional phase-encoded images of the human visual cortex using a simple surface transceiver coil. Finally, different contrasts demonstrated the clinical versatility of the new accelerated sequence. RESULTS: Images were acquired with an acceleration factor of 3.9, compared with the previous implementation of FREE, without exceeding specific absorption rate limits. Different contrasts can easily be acquired without major modifications, including inversion recovery-type images. CONCLUSION: FREE initially illustrated the feasibility of performing slice-selective 2D imaging of the human brain without the need for a B0 gradient along the y-direction. The multi-echo version maintains the advantages that B 1 + $$ {\mathrm{B}}_1^{+} $$ encoding provides but represents an important step toward improving the clinical feasibility of such sequences. Additional acceleration and more advanced reconstruction techniques could further improve the clinical viability of FREE-based techniques.

Correcting image distortions from a nonlinear B 1 + $$ {\boldsymbol{B}}_{\mathbf{1}}

PURPOSE: To correct image distortions that result from nonlinear spatial variation in the transmit RF field amplitude ( B 1 + $$ {B}_1^{+} $$ ) when performing spatial encoding with the method called frequency-modulated Rabi encoded echoes (FREE). THEORY AND METHODS: An algorithm developed to correct image distortion resulting from the use of nonlinear static field (B0 ) gradients in standard MRI is adapted herein to correct image distortion arising from a nonlinear B 1 + $$ {B}_1^{+} $$ -gradient field in FREE. From a B 1 + $$ {B}_1^{+} $$ -map, the algorithm performs linear interpolation and intensity scaling to correct the image. The quality of the distortion correction is evaluated in 1.5T images of a grid phantom and human occipital lobe. RESULTS: An expanded theoretical description of FREE revealed the symmetry between this B 1 + $$ {B}_1^{+} $$ -gradient field spatial-encoding and standard B0 -gradient field spatial-encoding. The adapted distortion-correction algorithm substantially reduced image distortions arising in the spatial dimension that was encoded by the nonlinear B 1 + $$ {B}_1^{+} $$ gradient of a circular surface coil. CONCLUSION: Image processing based on straightforward linear interpolation and intensity scaling, as previously applied in conventional MRI, can effectively reduce distortions in FREE images acquired with nonlinear B 1 + $$ {B}_1^{+} $$ -gradient fields.

B1 -gradient-based MRI using frequency-modulated Rabi-encoded echoes.

PURPOSE: Reduce expense and increase accessibility of MRI by eliminating pulsed field (B0 ) gradient hardware. METHODS: A radiofrequency imaging method is described that enables spatial encoding without B0 gradients. This method, herein referred to as frequency-modulated Rabi-encoded echoes (FREE), utilizes adiabatic full passage pulses and a gradient in the RF field (B1 ) to produce spatially dependent phase modulation, equivalent to conventional phase encoding. In this work, Cartesian phase encoding was accomplished using FREE in a multi-shot double spin-echo sequence. Theoretical analysis and computer simulations investigated the influence of resonance offset and B1 -gradient steepness and magnitude on reconstruction quality, which limit other radiofrequency imaging methodologies. Experimentally, FREE was compared to conventional phase-encoded MRI on human visual cortex using a simple surface transceiver coil. RESULTS: Image distortions occurred in FREE when using nonlinear B1 fields where the phase dependence becomes nonlinear, but with minimal change in signal intensity. Resonance offset effects were minimal for Larmor frequencies within the adiabatic full-passage pulse bandwidth. CONCLUSION: For the first time, FREE enabled slice-selective 2D imaging of the human brain without a B0 gradient in the y-direction. FREE achieved high resolution in regions where the B1 gradient was steepest, whereas images were distorted in regions where nonlinearity in the B1 gradient was significant. Given that FREE experiences no significant signal loss due to B1 nonlinearities and resonance offset, image distortions shown in this work might be corrected in the future based on B1 and B0 maps.

Emerging ethical issues raised by highly portable MRI research in remote and resource-limited international settings.

Smaller, more affordable, and more portable MRI brain scanners offer exciting opportunities to address unmet research needs and long-standing health inequities in remote and resource-limited international settings. Field-based neuroimaging research in low- and middle-income countries (LMICs) can improve local capacity to conduct both structural and functional neuroscience studies, expand knowledge of brain injury and neuropsychiatric and neurodevelopmental disorders, and ultimately improve the timeliness and quality of clinical diagnosis and treatment around the globe. Facilitating MRI research in remote settings can also diversify reference databases in neuroscience, improve understanding of brain development and degeneration across the lifespan in diverse populations, and help to create reliable measurements of infant and child development. These deeper understandings can lead to new strategies for collaborating with communities to mitigate and hopefully overcome challenges that negatively impact brain development and quality of life. Despite the potential importance of research using highly portable MRI in remote and resource-limited settings, there is little analysis of the attendant ethical, legal, and social issues (ELSI). To begin addressing this gap, this paper presents findings from the first phase of an envisioned multi-staged and iterative approach for creating ethical and legal guidance in a complex global landscape. Section 1 provides a brief introduction to the emerging technology for field-based MRI research. Section 2 presents our methodology for generating plausible use cases for MRI research in remote and resource-limited settings and identifying associated ELSI issues. Section 3 analyzes core ELSI issues in designing and conducting field-based MRI research in remote, resource-limited settings and offers recommendations. We argue that a guiding principle for field-based MRI research in these contexts should be including local communities and research participants throughout the research process in order to create sustained local value. Section 4 presents a recommended path for the next phase of work that could further adapt these use cases, address ethical and legal issues, and co-develop guidance in partnership with local communities.

Seroprevalence and geographical distribution of sero-positive blood donors to Trypanosoma cruzi at the central blood bank of the National Medical Center "La Raza".

BACKGROUND: Trypanosoma cruzi is a protozoan parasite that causes Chagas disease endemic to Latin-America. It is estimated that 1.0 to 1.5% of Mexicans are infected with T. cruzi, which constitutes a potential risk of disease transmission via contaminated blood. New cases are being reported worldwide due to the migration of infected people from endemic areas. STUDY DESIGN AND METHODS: Serum samples were collected from donors at the Central Blood Bank of the National Medical Center "La Raza" from July 2008 to December 2015 and analyzed for T. cruzi antibodies using Enzyme-linked Immunosorbent Assays. Blood donors were classified serologically as either negative or positive for Chagas disease based on the Official Mexican Standard NOM-032-SSA2-2014. The geographical distribution of sero-positive donors for Chagas disease was then determined based on the donor's areas of residence. RESULTS: Of the 510, 047 donors, 595 tested positive for Chagas disease. We found a prevalence of 0.12%, was higher in males (0.13%) than females (0.08%) In both genders, there were more sero-positive donors aged 51-65 years as compared to other age groups. Overall there were more positive donors from the State of Mexico, northern area of Mexico City, and southern area of Hidalgo State, with rates of 67.4%, 20.6%, and 5.9%, respectively. CONCLUSIONS: The seroprevalence of Chagas disease in blood donors attending to La Raza BB is low. Chagas disease is more prevalent in the older age groups; most sero-positive donors are from areas considered non-endemic to Chagas disease.

Parámetros endoscópicos y clínicos en la evaluación del grado de hipertensión mortal. Valor de la gradiente de albúmina de suero-líquido ascítico / Endoscopics and clinics parameters in the portal hypertension degree

Se realizó un estudio prospectivo en treintiún (31) pacientes con diagnóstico de ascítis, hospitalizados en el servicio de Medicina del Hospital Nacional Cayetano Heredia (H.N.C.H). La finalidad del presente trabajo fue investigar la asociación entre el nivel de la gradiente de albúmina de suero-líquido ascítico elevada (GRAD-Alb alta) con el grado y desarrollo de várices esofágicas evaluadas por procedimientos endoscópicos. De igual manera, analizar la relación entre el nivel de la GRAD-Alb alta y el grado de disfunción hepática evaluada por la clasificación de Child-Pugh. En nuestra serie se demostró que el nivel de la GRAD-Alb alta permite detectar pacientes con várices esofágicas, obteniéndose como indicador de presencia de várices un valor de GRAD-Alb mayor de 1,435ñ0,015g./dl. Se obtuvo que el nivel de la GRAD-Alb elevada no se encuentra asociado al grado de disfunción hepática (según la clasificación de Child-Pugh), prolongación del tiempo de protrombina, nivel de bilirrubina sérica, grado de encefalopatía, ni grado de ascítis; sin embargo, se demostró asociación y correlación débil con el nivel de albúmina sérica