Effect of superparamagnetic particles as oral contrast medium at magnetic resonance imaging. A phase I clinical study.

Non-biodegradable superparamagnetic particles were used as an oral contrast medium in different concentrations, and evaluated in 25 human volunteers. The aim of the study was to determine the most appropriate concentration of the contrast medium, and to evaluate the effect, distribution, safety and tolerance. With the concentration of 1.0 g/l a substantial reduction of the signal intensity in the bowel was achieved in both T1 and T2 weighted images. The intraabdominal structures were well differentiated from the bowels containing contrast medium. 'Metal' artifacts and blurring of adjacent structures, probably due to an increased local concentration, were observed at higher dosages. The distribution of the preparation in the gastrointestinal tract varied between individuals. As a rule a good contrast effect was achieved in the small bowel with the exception of the duodenum. The contrast medium was well accepted and did not cause any side effects of clinical importance. The results suggest that the preparation is well tolerated by humans and may be a useful contrast medium for abdominal MR imaging.