Park Bu S, Razjouyan Amir, Angelone Leonardo M, McCright Brent, Rajan Sunder S
U.S. FDA, CBER, OTAT Division of Cellular and Gene Therapies, Silver Spring, MD 20993-0002 USA.
U.S. FDA, CDRH, OSEL, Division of Biomedical Physics, Silver Spring, MD 20993-0002 USA.
IEEE Trans Electromagn Compat. 2017 Oct;59(5):1390-1399. doi: 10.1109/TEMC.2017.2678201.
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|B|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 (B) 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|B|equal to 2 T at the coil isocenter and whole body averaged SAR equal to 4W/kg.
本研究描述了乳房组织扩张器装置的磁共振成像(MRI)相关射频(RF)安全性评估,以建立安全标准。使用含有乳房扩张器的凝胶体模在64 MHz下进行了数值模拟和实验测量。此外,利用成年女性模型进行了计算建模(64 MHz和128 MHz),该模型包含一个虚拟植入的乳房组织扩张器装置,处于四个成像标志位置。乳房组织扩张器装置的存在导致比吸收率(SAR)和|B|分布发生显著变化。使用乳房扩张器装置时,SAR变化的主要来源是扩张器的盐水填充袋。相反,射频磁场(B)的变化主要由金属端口引起。由于引入扩张器装置,电场强度的测量值没有显著增加。在植入物附近组织中,最大1g或10g平均SAR值低于在患者身体其他区域预期的值,此时线圈等中心处的|B|均归一化为2 T,全身平均SAR等于4W/kg。