RF Safety Evaluation of a Breast Tissue Expander Device for MRI: Numerical Simulation and Experiment
Bu S Park1, Amir Razjouyan2, Leonardo M Angelone2
1U.S. FDA, CBER, OTAT Division of Cellular and Gene Therapies, Silver Spring, MD 20993-0002 USA.
None:
This study describes the MRI-related radio frequency (RF) safety evaluation of breast tissue expander devices to establish safety criteria. Numerical simulations and experimental measurements were performed at 64 MHz with a gel phantom containing a breast expander. Additionally, computational modeling was performed (64 and 128 MHz) with an adult female model, containing a virtually implanted breast tissue expander device for four imaging landmark positions. The presence of the breast tissue expander device led to significant alterations in specific absorption rate (SAR) and|B1+|distributions. The main source of SAR alterations with the use of the breast expander device was the saline-filled pouch of the expander. Conversely, the variation of RF magnetic field (B1+) was mainly caused by the metallic port. The measured values of electric field magnitude did not increase significantly due to the introduction of the expander device. The maximum 1g- or 10g-averaged SAR values in tissues near the implant were lower than those expected in other regions of the patient body with normalization of both|B1+|equal to 2 microT at the coil isocenter and whole body averaged SAR equal to 4W/kg.
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