Gadodiamide Injection-Enhanced MR Imaging of the Body: Results of a Multicenter Trial

Abstract

<b>Rationale and Objectives.</b> To evaluate the safety and efficacy of gadodiamide injection at a dose of 0.3 mmol/kg for magnetic resonance (MR) imaging of the body (musculoskeletal system, abdomen, retroperitoneal space, pelvis, and breast) in a multicenter study involving 330 patients. <b>Methods.</b> Unenhanced T1-weighted MR images were obtained before and after 0.3 mmol/kg gadodiamide injection was administered in each patient. The patients were monitored for changes in vital signs, and laboratory studies were performed. The MR images were evaluated for contrast enhancement. <b>Results.</b> No serious adverse events or clinically important changes in vital signs or laboratory values were observed. Evaluation of the MR images demonstrated abnormalities in 274 (84%) of the 326 patients included for efficacy analysis. Gadodiamide injection helped diagnostically in the evaluation of the images of 246 (75%) of all patients, and it added diagnostic value in 210 (77%) of the 274 patients with abnormalities. With respect to the evaluation of enhancing abnormalities of the specific body areas, gadodiamide injection added diagnostic value for the musculoskeletal system in 89% of cases, for the abdomen (liver and spleen) in 73%, the retroperitoneal space (kidneys) in 94%, the pelvis (bladder and prostate) in 39%, and the breast in 100% of the cases. <b>Conclusion.</b> Gadodiamide injection administered at 0.3 mmol/kg is safe and effective for MR imaging of patients with suspected lesions or abnormalities of the body.