PERFLUBRON AS A GASTROINTESTINAL MR-IMAGING CONTRAST AGENT IN THE PEDIATRIC POPULATION

Objective. To evaluate the safety and efficacy of orally administered perflubron for bowel recognition on MR imaging in a pediatric populati on. Materials and Methods. A multicenter trial evaluated 39 pediatric subjects before and after ingestion of perflubron with T1-, proton-den sity, and T2-weighted sequences through the abdomen and/or pelvis. Pos t-contrast images were compared with pre-contrast images. Safety was e valuated through assessment of adverse events, clinical laboratory par ameters, and vital signs. Results. With regard to efficacy analysis, i mprovement in the percent of bowel darkened was observed for 85 % of t he subjects on T1-weighted images and for 95 % of the subjects on prot on-density and T2-weighted images. For images of the abdominal region, the percent of bowel darkened was improved for 90-92 % of the subject s across pulse sequences, Improvement rates for the images of the pelv ic region ranged from 71 % to 100 %. For at least 75 % of the subjects , proton-density and T2-weighted images of the body and tail of the pa ncreas, left lobe of the liver, mesenteric fat, and pathological tissu e were improved relative to predosing images, Twenty-three percent of the subjects experienced some adverse effects, most of which were mino r and related to the digestive system. Clinical laboratory and vital s ign evaluations revealed no trends associated with the administration of perflubron. Conclusion. Perflubron is a relatively safe and effecti ve gastrointestinal MR contrast agent in the pediatric population.