Perflubron as an oral contrast agent for MR imaging: Results of a phase III clinical trial

PURPOSE: To assess perflubron for magnetic resonance (MR) imaging in the abdomen and pelvis in a multicenter trial. MATERIALS AND METHODS: MR images were obtained in 127 subjects before and after ingestion of perflubron with T1-, proton-density-, and T2-weighted sequences at 0.38, 1.0, or 1.5 T. Postcontrast images were compared with baseline images, and percentage of additional bowel darkened, distinction of bowel from adjacent tissue, and change in image artifact were graded. RESULTS: Perflubron increased the bowel darkening in over 92% of subjects with all sequences and field strengths. It improved definition of the left lobe of the liver and body and tail of the pancreas in 67%, 29%, and 42% of subjects, respectively, and of the uterus and bladder in 80% and 76%. Abnormal tissue was more conspicuous in 69% of subjects. Highest scores were achieved when the upper abdomen was imaged 5- 30 minutes and the pelvis 10-40 minutes after ingestion. No image artifacts or side effects were attributed to perflubron. CONCLUSION: Perflubron is safe, and its efficacy was unaffected by pulse sequences, magnetic field strength, or time delay.