First clinical trial of a new superparamagnetic iron oxide for use as an oral gastrointestinal contrast agent in MR imaging.

The authors report the results of preclinical testing and initial clinical application of a superparamagnetic iron oxide specifically prepared as a contrast agent for magnetic resonance (MR) imaging of the gastrointestinal tract. MR imaging was performed at 0.6 and 1.5 T in 15 volunteers. Images of the upper abdomen and pelvis were obtained before and after ingestion of the contrast material at doses of 22.5-225.0 mg of iron in 600-900 L. Two readers scored the images. Delivery of contrast material into the proximal and distal small bowel, with obvious loss of signal intensity (T2 enhancement), was achieved in all subjects. Enhanced images showed improved delineation of the head and tail of the pancreas, anterior margins of the kidneys, and paraaortic region. The contrast agent did not generate artifacts, an improvement over prototype formulations evaluated previously in animals. Except for a brief episode of diarrhea in five subjects, the agent was well tolerated. Use of this contrast agent improved the diagnostic quality of abdominal MR images by enabling the distinction of the bowel from nonbowel structures at concentrations that did not produce image distortion.