Rinck P A, Smevik O, Nilsen G, Klepp O, Onsrud M, Oksendal A, Børseth A
MR Center, University of Trondheim, Norway.
Radiology. 1991 Mar;178(3):775-9. doi: 10.1148/radiology.178.3.1994417.
Two phase 2 clinical trials of an oral superparamagnetic contrast agent for enhancement on magnetic resonance images of the intestine were performed. In trial 1, 31 male patients with cancer of the testis underwent follow-up examinations of the abdomen at 0.5 and 1.5 T after oral administration of magnetic particles. In trial 2, 31 female patients with pelvic and lower abdominal disease were examined at 1.5 T after administration of the contrast material. The patients each ingested 800 mL of contrast material over approximately 2 hours. Concentrations of 0.25 and 0.5 g/L did not induce blurring or metallic artifacts. Distribution was homogeneous through the gastrointestinal tract. In all patients, a loss of signal intensity was observed on proton density-, T1-, and T2-weighted images. The diagnostic information from postcontrast images in trial 2 was greater in 16 patients (52%). Contrast enhancement was independent of field strength; no major side effects were observed. Artifacts from moving bowels were less troublesome, and delineation of intraabdominal and pelvic organs was better with the use of oral magnetic particles.
进行了两项关于口服超顺磁性造影剂以增强肠道磁共振图像的2期临床试验。在试验1中，31名睾丸癌男性患者在口服磁性颗粒后于0.5 T和1.5 T磁场下接受腹部随访检查。在试验2中，31名患有盆腔和下腹部疾病的女性患者在给予造影剂后于1.5 T磁场下接受检查。患者在约2小时内各摄入800 mL造影剂。0.25 g/L和0.5 g/L的浓度未引起图像模糊或金属伪影。造影剂在胃肠道内分布均匀。在所有患者中，质子密度加权、T1加权和T2加权图像上均观察到信号强度降低。试验2中，16名患者（52%）造影后图像的诊断信息更多。造影增强与场强无关；未观察到重大副作用。肠道蠕动产生的伪影影响较小，使用口服磁性颗粒能更好地勾勒腹腔和盆腔器官轮廓。
