Objective. To evaluate the safety and efficacy of orally administered perflubron for bowel recognition on MR imaging in a pediatric population. Materials and methods. A multicenter trial evaluated 39 pediatric subjects before and after ingestion of perflubron with T1-, proton-density, and T2-weighted sequences through the abdomen and/or pelvis. Post-contrast images were compared with pre-contrast images. Safety was evaluated through assessment of adverse events, clinical laboratory parameters, and vital signs. Results. With regard to efficacy analysis, improvement in the percent of bowel darkened was observed for 85% of the subjects on T1-weighted images and for 95% of the subjects on proton-density and T2-weighted images. For images of the abdominal region, the percent of bowel darkened was improved for 90-92% of the subjects across pulse sequences. Improvement rates for the images of the pelvic 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 pancreas, left lobe of the liver, mesenteric fat, and pathological tissue were improved relative to predosing images. Twenty-three percent of the subjects experienced some adverse effects, most of which were minor and related to the digestive system. Clinical laboratory and vital sign evaluations revealed no trends associated with the administration of perflubron. Conclusion. Perflubron is a relatively safe and effective gastrointestinal MR contrast agent in the pediatric population.
ASJC Scopus subject areas
- Pediatrics, Perinatology, and Child Health
- Radiology Nuclear Medicine and imaging