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 t he abdomen and pelvis in 9 multicenter trial. MATERIALS AND METHODS: M R images were obtained in 127 subjects before and after ingestion of p erflubron with T1-, proton-density-, and T2-weighted sequences at 0.38 , 1.0,or 1.5 T. Postcontrast images were compared with baseline iinage s, and percentage of additional bowel darkened distinction of bowel fr om adjacent tissue, and change in image artifact were graded. RESULTS: Perflubron increased the bowel darkening in over 92% of subjects with all sequences and held strengths. It improved definition of the left lobe of the liver and body and tail of the pancreas in 67%, 29%, and 4 2% 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 a nd the pelvis 10-40 minutes after ingestion. No image artifacts or sid e effects were attributed to perflubron. CONCLUSION: Perflubron is saf e, and its efficacy was unaffected by pulse sequences, magnetic field strength, or time delay.