ORAL MAGNETIC PARTICLES (FERRISTENE) AS A CONTRAST-MEDIUM IN ABDOMINAL MAGNETIC-RESONANCE-IMAGING

Rationale and Objectives. In this phase III study, we evaluated the ef ficacy and safety of a negative contrast medium, ferristene (oral magn etic particles), among 277 patients undergoing magnetic resonance (MR) imaging of the abdomen.Methods. Enhanced (800 ml ferristene) MR image s were compared with unenhanced MR images in an intraindividual-patien t 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 pati ents, particularly in those with abdominal masses, lymphoma, or pancre atic disease. Distribution of ferristene in the stomach, duodenum, jej unum, 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 th e use of ferristene, and ferristene disclosed additional findings in 2 2% 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 patien ts it added useful diagnostic information.