A MULTICENTER CLINICAL-TRIAL OF GADOLITE ORAL SUSPENSION AS A CONTRAST AGENT FOR MRI

The purpose of this study was to assess the effectiveness and safety o f Gadolite Oral Suspension as a gastrointestinal (GI) contrast agent f or MRI in a phase II and two phase III multicenter clinical trials. Ga dolite was administered to 306 patients with known or suspected abdomi nal and/or pelvic disease, MRI with T1-and T2-weighted sequences was p erformed before and after ingestion. Efficacy was evaluated by having two masked readers rate the certainty of their MR diagnosis (0 = uncer tain, 1 = probable, 2 = definite) on randomly presented pre-and post-G adolite Oral Suspension enhanced images. Principal investigators also evaluated the images and established the final diagnosis. Vital signs, clinical chemistries, and adverse events were documented, Blood and m ine samples were analyzed for gadolinium content to determine whether Gadolite Oral Suspension was absorbed systemically, Certainty in MR di agnosis increased significantly (P < .001) for both blinded readers be tween pre- and post- Gadolite images (.49 - 1.18 for reader 1; .46 - 1 .53 for reader 2), Sensitivity, specificity, and accuracy also increas ed for both masked readers. No gadolinium was detected in blood or uri ne samples. There were no serious adverse events and no apparent drug- related trends in mean vital signs or laboratory values, Gadolite is a highly effective, safe, and well tolerated contrast agent for clinica l use with MRI.