这项研究旨在评估新型MRI条件乳腺组织扩张器(MotivaFlora®)在其首个人体多病例应用中的潜在并发症和对磁共振成像(MRI)图像质量的影响。24例具有36个扩张器的患者接受了T1加权的非对比乳腺MRI,T2加权,和扩散加权成像(DWI)序列在3T单位乳房组织扩张器交换手术前,在MRI期间和之后监测潜在的并发症。三名获得董事会认证的乳腺放射科医生使用四级量表(“差”,\"足够\",\"好\",和“优秀”),读者间可靠性用肯德尔的τb进行评估。将T1加权和DWI序列上与RFID相关的伪影的最大直径与Wilcoxon符号秩检验进行比较。所有24项检查均完成,无患者相关或装置相关并发症。所有检查的T1加权和T2加权序列均具有“出色”的图像质量和中值11mm(IQR9-12mm)的RFID伪影最大直径,显著低于(p<0.001)DWI图像(中位数32.5mm,IQR28.5-34.5毫米)。在63%的检查中,DWI质量至少被评为“良好”,具有较强的读者间可靠性(肯德尔的τb0.837,95%CI0.687-0.952)。这项首次人体研究证实了这种新型扩张器的MRI条件轮廓,这不会影响T1加权和T2加权序列的图像质量,并且会适度影响DWI质量。
This study aims to assess potential complications and effects on the magnetic resonance imaging (MRI) image quality of a new MRI-conditional breast tissue expander (Motiva Flora®) in its first in-human multi-
case application. Twenty-four patients with 36 expanders underwent non-contrast breast MRI with T1-weighted, T2-weighted, and diffusion-weighted imaging (DWI) sequences on a 3 T unit before breast tissue expander exchange surgery, being monitored during and after MRI for potential complications. Three board-certified breast radiologists blindly and independently reviewed image quality using a four-level scale (\"poor\", \"sufficient\", \"good\", and \"excellent\"), with inter-reader reliability being assessed with Kendall\'s τb. The maximum diameters of RFID-related artifacts on T1-weighted and DWI sequences were compared with the Wilcoxon signed-rank test. All 24 examinations were completed without patient-related or device-related complications. The T1-weighted and T2-weighted sequences of all the examinations had \"excellent\" image quality and a median 11 mm (IQR 9-12 mm) RFID artifact maximum diameter, significantly lower (p < 0.001) than on the DWI images (median 32.5 mm, IQR 28.5-34.5 mm). DWI quality was rated at least \"good\" in 63% of the examinations, with strong inter-reader reliability (Kendall\'s τb 0.837, 95% CI 0.687-0.952). This first in-human study confirms the MRI-conditional profile of this new expander, which does not affect the image quality of T1-weighted and T2-weighted sequences and moderately affects DWI quality.