Oral magnetic particles (ferristene) as a contrast medium in abdominal magnetic resonance imaging

Rationale and Objectives. In this phase III study, we evaluated the efficacy and safety of a negative contrast medium, ferristene (oral magnetic particles), among 277 patients undergoing magnetic resonance (MR) imaging of the abdomen. Methods. Enhanced (800 ml ferristene) MR images were compared with unenhanced MR images in an intraindividual-patient control design. Adverse events were recorded. The examinations were performed on 1.5-T MR systems (T1- and T2-weighted sequences). Results. Ferristene increased the diagnostic information in 50.9% of the patients, particularly in those with abdominal masses, lymphoma, or pancreatic disease. Distribution of ferristene in the stomach, duodenum, jejunum, and ileum was complete or sufficient in 70.5-85% of the studies. In 64% of the patients, we were confident in the MR findings after the use of ferristene, and ferristene disclosed additional findings in 22% of the patients. The incidence of adverse events was 9.0%, but only 3.6% of all patients experienced ferristene-related adverse events (e.g., nausea, vomiting). Most events were mild or moderate in intensity. Conclusion. Ferristene was well tolerated, and for 50% of the patients it added useful diagnostic information