Superiority of Ferumoxytol MRI Over Pre-Contrast Imaging in Patients With Intra-Axial Malignant Brain Lesions

Motivation: Patients with contraindications to gadolinium-based contrast agents (GBCAs), such as those with renal impairment, require alternative imaging options that ensure safety without compromising diagnostic quality. Goal(s): This study aimed to demonstrate the superiority of ferumoxytol (FER)-enhanced MRI over pre-contrast imaging in assessing malignant brain lesions, focusing on improving lesion visualization. Approach: This study was conducted by an independent clinical research organization and adhered to FDA guidelines. Three neuroradiologists evaluated FER-enhanced MRI images against pre-contrast scans in 153 patients with primary or metastatic brain tumors. Results: FER-enhanced MRI demonstrated significant improvement in lesion visualization compared to pre-contrast imaging. Impact: The results from this study provide strong evidence that ferumoxytol could serve as a safe and effective alternative to gadolinium-based contrast agents, particularly for patients with contraindications, potentially leading to its FDA approval for brain tumor imaging.