Lymph node metastases: safety and effectiveness of MR imaging with ultrasmall superparamagnetic iron oxide particles--initial clinical experience.

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Abstract
To evaluate the clinical and biologic safety of ultrasmall superparamagnetic iron oxide particles (AMI-227) as a contrast agent for magnetic resonance (MR) lymphography and to assess their efficacy for the differentiation of metastatic and benign nodes in patients with urologic and pelvic cancer. Thirty adults suspected of having lymph node metastases underwent MR imaging before and 22-26 hours after intravenous infusion of AMI-227 (1.7 mg Fe/kg). Sixty histopathologically proved lymph nodes were analyzed on MR images, and 29 of these nodes were also analyzed quantitatively. AMI-227 was well tolerated with no major side effects. It allowed the detection of 10 additional nodes relative to those detected at MR imaging without AMI-227. None of the 27 metastatic nodes showed a decrease in signal intensity (SI) on AMI-227-enhanced images; nine of 27 metastatic nodes showed an increase in SI on T1-weighted images, probably resulting from altered capillary permeability in the tumor. A visually perceptible reduction in SI, indicating active AMI-227 uptake, was observed on postcontrast T2- and T2*-weighted images in 16 of 21 benign nodes. The SI ratio of benign nodes was lower than that of metastatic nodes on T2- and T2*-weighted images. The sensitivity of AMI-227-enhanced MR lymphography was 100%, and the specificity was 80%. AMI-227 is safe and may facilitate the differentiation of metastatic and benign nodes in patients with urologic and pelvic cancers.

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