POSITIVE BOWEL CONTRAST AGENT FOR MR-IMAGING OF THE ABDOMEN - PHASE-II AND PHASE-III CLINICAL-TRIALS

PURPOSE: To evaluate the efficacy and safety of two dose levels of an orally administered ferric ammonium citrate-based contrast agent for b owel enhancement on T1-weighted spin-echo magnetic resonance (MR) imag es in 222 patients with known or suspected abnormality of the upper ab domen. MATERIALS AND METHODS: Adverse reactions were graded for intens ity, frequency, duration, and relationship to the contrast agent. Twel ve unblinded readers compared enhanced with unenhanced images; all MR images were evaluated by two independent offsite radiologists in a bli nded review. RESULTS: No statistically significant changes in mean vit al signs or laboratory values were seen. Forty-eight of 220 patients ( 22%) reported minor side effects. The readers found increased intralum inal signal intensity and improved contrast enhancement of the gastroi ntestinal tract and distention and improved signal homogeneity in 101- 107 cases (89%-98%) after ingestion; the blinded reviewers' findings w ere similar. CONCLUSION: The contrast agent provided new or additional radiologic information in 142 patients (64%), specific additional inf ormation in a detected abnormality in 46 of 142 patients (32%), and in formation that changed diagnosis, management, or surgical approach in 22 of 142 patients (15%).