Induced radiofrequency fields in patients undergoing MR examinations: insights for risk assessment.

Purpose. To characterize and quantify the induced radiofrequency (RF) electric (E)-fields andB1+rmsfields in patients undergoing magnetic resonance (MR) examinations; to provide guidance on aspects of RF heating risks for patients with and without implants; and to discuss some strengths and limitations of safety assessments in current ISO, IEC, and ASTM standards to determine the RF heating risks for patients with and without implants.Methods. InducedE-fields andB1+rmsfields during 1.5 T and 3 T MR examinations were numerically estimated for high-resolution patient models of the Virtual Population exposed to ten two-port birdcage RF coils from head to feet imaging landmarks over the full polarization space, as well as in surrogate ASTM phantoms.Results. Worst-caseB1+rmsexposure greater than 3.5µT (1.5 T) and 2µT (3 T) must be considered for all MR examinations at the Normal Operating Mode limit. Representative inducedE-field and specific absorption rate distributions under different clinical scenarios allow quick estimation of clinical factors of high and reduced exposure.B1shimming can cause +6 dB enhancements toE-fields along implant trajectories. The distribution and magnitude of inducedE-fields in the ASTM phantom differ from clinical exposures and are not always conservative for typical implant locations.Conclusions.Field distributions in patient models are condensed, visualized for quick estimation of risks, and compared to those induced in the ASTM phantom. InducedE-fields in patient models can significantly exceed those in the surrogate ASTM phantom in some cases. In the recent 19ε2revision of the ASTM F2182 standard, the major shortcomings of previous versions have been addressed by requiring that the relationship between ASTM test conditions andin vivotangentialE-fields be established, e.g. numerically. With this requirement, the principal methods defined in the ASTM standard for passive implants are reconciled with those of the ISO 10974 standard for active implantable medical devices.

Novel test field diversity method for demonstrating magnetic resonance imaging safety of active implantable medical devices.

Electromagnetic (EM) radiofrequency (RF) safety testing of elongated active implantable medical devices (AIMD) during magnetic resonance imaging (MRI) requires an RF response model of the implant to assess a wide range of exposure conditions. The model must be validated using a sufficiently large set of incident tangential electric field ([Formula: see text]) conditions that provide diversified exposure. Until now, this procedure was very time consuming and often resulted in poorly defined [Formula: see text] conditions. In this paper, we propose a test field diversity (TFD) validation method that provides more diverse exposure conditions of high fidelity, thereby decreasing the number of implant routings to be tested. The TFD method is based on the finding that the amplitude and phase of [Formula: see text] along a single lead path in a cylindrical phantom can be sufficiently varied by changing the polarization of the incident 64 and 128 MHz magnetic fields inside standard birdcage test coils. The method is validated, its benefits are demonstrated, and an uncertainty budget is developed. First, the numerically determined field conditions were experimentally verified. The RF transfer function of a 90 cm long spinal cord stimulator was successfully validated with the TFD approach and excitation conditions that cover a > 10 dB dynamic range of RF-heating enhancement factors (for identical trajectory-averaged incident field strength). The new TFD method yields an improved and reliable validation of the AIMD RF response model with low uncertainty, i.e. < 1.5 dB, for both 1.5 and 3.0 T evaluations.

Anatomical Model Uncertainty for RF Safety Evaluation of Metallic Implants Under MRI Exposure.

The Virtual Population (ViP) phantoms have been used in many dosimetry studies, yet, to date, anatomical phantom uncertainty in radiofrequency (RF) research has largely been neglected. The objective of this study is to gain insight, for the first time, regarding the uncertainty in RF-induced fields during magnetic resonance imaging associated with tissue assignment and segmentation quality and consistency in anatomical phantoms by evaluating the differences between two generations of ViP phantoms, ViP1.x and ViP3.0. The RF-induced 10g-average electric (E-) fields, tangential E-fields distribution along active implantable medical devices (AIMD) routings, and estimated AIMD heating were compared for five phantoms that are part of both ViP1.x and ViP3.0. The results demonstrated that differences exceeded 3 dB (-29%, +41%) for local quantities and 1 dB (±12% for field, ±25% for power) for integrated and volume-averaged quantities (e.g., estimated AIMD-heating and 10 g-average E-fields), while the variation across different ViP phantoms of the same generation can exceed 10 dB (-68% and +217% for field, -90% and +900% for power). In conclusion, the anatomical phantom uncertainty associated with tissue assignment and segmentation quality/consistency is larger than previously assumed, i.e., 0.6 dB or ±15% (k = 1) for AIMD heating. Further, multiple phantoms based on different volunteers covering the target population are required for quantitative analysis of dosimetric endpoints, e.g., AIMD heating, which depend on patient anatomy. Phantoms with the highest fidelity in tissue assignment and segmentation should be used, as these ensure the lowest uncertainty and possible underestimation of exposure. To verify that the uncertainty decreases monotonically with improved phantom quality, the evaluation of differences between phantom generations should be repeated for any improvement in segmentation. Bioelectromagnetics. 2019;40:458-471. © 2019 Bioelectromagnetics Society.

Efficient and Reliable Assessment of the Maximum Local Tissue Temperature Increase at the Electrodes of Medical Implants under MRI Exposure.

Standard risk evaluations posed by medical implants during magnetic resonance imaging (MRI) includes (i) the assessment of the total local electromagnetic (EM) power (P) absorbed in the vicinity of the electrodes and (ii) the translation of P into a local in vivo tissue temperature increase ∆T (P2∆T) in animal experiments or simulations. We investigated the implant/tissue modeling requirements and associated uncertainties by applying full-wave EM and linear bioheat solvers to different implant models, incident field conditions, electrode configurations, and tissue models. Results show that the magnitude of the power is predominately determined by the lead, while the power distribution, and the P2∆T conversion, is determined by the electrode and surrounding tissues. P2∆T is strongly dependent on the size of the electrode, tissue type in contact with the electrode, and tissue inhomogeneity (factor of >2 each) but less on the modeling of the lead (<±10%) and incident field distribution along the lead (<±20%). This was confirmed by means of full-wave simulations performed with detailed high-resolution anatomical phantoms exposed to two commonly used MRI clinical scenarios (64 and 128 MHz), resulting in differences of less than 6%. For the determination of P2∆T, only the electrode and surrounding tissues must be modeled in great detail, whereas the lead can be modeled as a computationally efficient simplified structure exposed to a uniform field. The separate assessments of lead and electrode reduce the overall computational effort by several orders of magnitude. The errors introduced by this simplification can be considered by uncertainty terms. Bioelectromagnetics. 2019;40:422-433. © 2019 Bioelectromagnetics Society.

Novel mechanistic model and computational approximation for electromagnetic safety evaluations of electrically short implants.

This paper addresses unresolved issues related to the safety of persons with conductive medical implants exposed to electromagnetic (EM) fields. When exposed to EM fields compatible with the reference limits-in particular <100 MHz-implants may enhance local fields and energy absorption to values much higher than the basic restrictions that are considered safe. A mechanistic model based on transfer functions has been postulated for elongated active implants at magnetic resonance imaging (MRI) frequencies and used as a basis for standards dealing with MRI implant safety. However, this mechanistic model is inconsistent with the behavior observed for electrically short implants, such as abandoned leads in MRI or active implants under low-frequency exposure conditions (e.g. wireless power transfer). In this paper, a new mechanistic model for electrically short implants is proposed that allows implant safety assessment to be decomposed into separate steps. Per tip-shape, it requires only a single simulation or measurement of the implant exposed under (semi-)homogeneous conditions. To validate the approach, predictions of the mechanistic model were compared to results of numerical simulations for electric- and magnetic-field exposures. The impact of parameters such as tissue properties, length, tip shape, and insulation thickness on safety- and compliance-relevant quantities was studied. Validation involving an anatomically detailed computational human body model with a realistic implant at multiple locations under electric and magnetic exposures resulted in prediction agreement on the order of 7% (maximal deviation <15%). The approach was found to be applicable for electrical lengths up to 20% of the effective wavelength and can be used to derive suitable testing procedures as well as to develop safety guidelines and standards.

On the estimation of the worst-case implant-induced RF-heating in multi-channel MRI.

The increasing use of multiple radiofrequency (RF) transmit channels in magnetic resonance imaging (MRI) systems makes it necessary to rigorously assess the risk of RF-induced heating. This risk is especially aggravated with inclusions of medical implants within the body. The worst-case RF-heating scenario is achieved when the local tissue deposition in the at-risk region (generally in the vicinity of the implant electrodes) reaches its maximum value while MRI exposure is compliant with predefined general specific absorption rate (SAR) limits or power requirements. This work first reviews the common approach to estimate the worst-case RF-induced heating in multi-channel MRI environment, based on the maximization of the ratio of two Hermitian forms by solving a generalized eigenvalue problem. It is then shown that the common approach is not rigorous and may lead to an underestimation of the worst-case RF-heating scenario when there is a large number of RF transmit channels and there exist multiple SAR or power constraints to be satisfied. Finally, this work derives a rigorous SAR-based formulation to estimate a preferable worst-case scenario, which is solved by casting a semidefinite programming relaxation of this original non-convex problem, whose solution closely approximates the true worst-case including all SAR constraints. Numerical results for 2, 4, 8, 16, and 32 RF channels in a 3T-MRI volume coil for a patient with a deep-brain stimulator under a head imaging exposure are provided as illustrative examples.

Virtual population-based assessment of the impact of 3 Tesla radiofrequency shimming and thermoregulation on safety and B1 + uniformity.

PURPOSE: To assess the effect of radiofrequency (RF) shimming of a 3 Tesla (T) two-port body coil on B1 + uniformity, the local specific absorption rate (SAR), and the local temperature increase as a function of the thermoregulatory response. METHODS: RF shimming alters induced current distribution, which may result in large changes in the level and location of absorbed RF energy. We investigated this effect with six anatomical human models from the Virtual Population in 10 imaging landmarks and four RF coils. Three thermoregulation models were applied to estimate potential local temperature increases, including a newly proposed model for impaired thermoregulation. RESULTS: Two-port RF shimming, compared to circular polarization mode, can increase the B1 + uniformity on average by +32%. Worst-case SAR excitations increase the local RF power deposition on average by +39%. In the first level controlled operating mode, induced peak temperatures reach 42.5°C and 45.6°C in patients with normal and impaired thermoregulation, respectively. CONCLUSION: Image quality with 3T body coils can be significantly increased by RF shimming. Exposure in realistic scan scenarios within guideline limits can be considered safe for a broad patient population with normal thermoregulation. Patients with impaired thermoregulation should not be scanned outside of the normal operating mode. Magn Reson Med 76:986-997, 2016. © 2015 Wiley Periodicals, Inc.

Convex optimization of MRI exposure for mitigation of RF-heating from active medical implants.

Local RF-heating of elongated medical implants during magnetic resonance imaging (MRI) may pose a significant health risk to patients. The actual patient risk depends on various parameters including RF magnetic field strength and frequency, MR coil design, patient's anatomy, posture, and imaging position, implant location, RF coupling efficiency of the implant, and the bio-physiological responses associated with the induced local heating. We present three constrained convex optimization strategies that incorporate the implant's RF-heating characteristics, for the reduction of local heating of medical implants during MRI. The study emphasizes the complementary performances of the different formulations. The analysis demonstrates that RF-induced heating of elongated metallic medical implants can be carefully controlled and balanced against MRI quality. A reduction of heating of up to 25 dB can be achieved at the cost of reduced uniformity in the magnitude of the B(1)(+) field of less than 5%. The current formulations incorporate a priori knowledge of clinically-specific parameters, which is assumed to be available. Before these techniques can be applied practically in the broader clinical context, further investigations are needed to determine whether reduced access to a priori knowledge regarding, e.g. the patient's anatomy, implant routing, RF-transmitter, and RF-implant coupling, can be accepted within reasonable levels of uncertainty.

Microwave beamforming for non-invasive patient-specific hyperthermia treatment of pediatric brain cancer.

We present a numerical study of an array-based microwave beamforming approach for non-invasive hyperthermia treatment of pediatric brain tumors. The transmit beamformer is designed to achieve localized heating-that is, to achieve constructive interference and selective absorption of the transmitted electromagnetic waves at the desired focus location in the brain while achieving destructive interference elsewhere. The design process takes into account patient-specific and target-specific propagation characteristics at 1 GHz. We evaluate the effectiveness of the beamforming approach using finite-difference time-domain simulations of two MRI-derived child head models from the Virtual Family (IT'IS Foundation). Microwave power deposition and the resulting steady-state thermal distribution are calculated for each of several randomly chosen focus locations. We also explore the robustness of the design to mismatch between the assumed and actual dielectric properties of the patient. Lastly, we demonstrate the ability of the beamformer to suppress hot spots caused by pockets of cerebrospinal fluid (CSF) in the brain. Our results show that microwave beamforming has the potential to create localized heating zones in the head models for focus locations that are not surrounded by large amounts of CSF. These promising results suggest that the technique warrants further investigation and development.

Time-multiplexed beamforming for noninvasive microwave hyperthermia treatment.

A noninvasive microwave beamforming strategy is proposed for selective localized heating of biological tissue. The proposed technique is based on time multiplexing of multiple beamformers. We investigate the effectiveness of the time-multiplexed beamforming in the context of brain hyperthermia treatment by using a high-fidelity numerical head phantom of an adult female from the Virtual Family (IT'IS Foundation) as our testbed. An operating frequency of 1 GHz is considered to balance the improved treatment resolution afforded by higher frequencies against the increased penetration through the brain afforded by lower frequencies. The exact head geometry and dielectric properties of biological tissues in the head are assumed to be available for the creation of patient-specific propagation models used in beamformer design. Electromagnetic and thermal simulations based on the finite-difference time-domain method are used to evaluate the hyperthermia performance of time-multiplexed beamforming and conventional beamforming strategies. The proposed time-multiplexing technique is shown to reduce the unintended heating of healthy tissue without affecting the treatment temperature or volume. The efficacy of the method is demonstrated for target locations in three different regions of the brain. This approach has the potential to improve microwave-induced localized heating for cancer treatment via hyperthermia or heat-activated chemotherapeutic drug release.

3D computational study of non-invasive patient-specific microwave hyperthermia treatment of breast cancer.

Non-invasive microwave hyperthermia treatment of breast cancer is investigated using three-dimensional (3D) numerical breast phantoms with anatomical and dielectric-properties realism. 3D electromagnetic and thermal finite-difference time-domain simulations are used to evaluate the focusing and selective heating efficacy in four numerical breast phantoms with different breast tissue densities. Beamforming is used to design and focus the signals transmitted by an antenna array into the breast. We investigate the use of propagation models of varying fidelity and complexity in the design of the transmitted signals. An ideal propagation model that is exactly matched to the actual patient's breast is used to establish a best-performance baseline. Simpler patient-specific propagation models based on a homogeneous breast interior are also explored to evaluate the robustness of beamforming in practical clinical settings in which an ideal propagation model is not available. We also investigate the performance of the beamformer as a function of operating frequency and compare single-frequency and multiple-frequency focusing strategies. Our study suggests that beamforming is a robust method of non-invasively focusing microwave energy at a tumor site in breasts of varying volume and breast tissue density.

Development of anatomically realistic numerical breast phantoms with accurate dielectric properties for modeling microwave interactions with the human breast.

Computational electromagnetics models of microwave interactions with the human breast serve as an invaluable tool for exploring the feasibility of new technologies and improving design concepts related to microwave breast cancer detection and treatment. In this paper, we report the development of a collection of anatomically realistic 3-D numerical breast phantoms of varying shape, size, and radiographic density which can readily be used in finite-difference time-domain computational electromagnetics models. The phantoms are derived from T1-weighted MRIs of prone patients. Each MRI is transformed into a uniform grid of dielectric properties using several steps. First, the structure of each phantom is identified by applying image processing techniques to the MRI. Next, the voxel intensities of the MRI are converted to frequency-dependent and tissue-dependent dielectric properties of normal breast tissues via a piecewise-linear map. The dielectric properties of normal breast tissue are taken from the recently completed large-scale experimental study of normal breast tissue dielectric properties conducted by the Universities of Wisconsin and Calgary. The comprehensive collection of numerical phantoms is made available to the scientific community through an online repository.