MULTICENTER TRIAL OF GADOTERIDOL, A NONIONIC GADOLINIUM CHELATE, IN PATIENTS WITH SUSPECTED HEAD AND NECK PATHOLOGY

PURPOSE: To evaluate the safety and efficacy of gadoteridol as an MR c ontrast agent in patients with suspected head and neck pathology. METH ODS: One hundred thirty-three adult patients were studied with MR at 1 2 clinical trial sites before and after the intravenous administration of 0.10 mmol/kg gadoteridol. After enrollment, patients underwent a c omplete physical examination. Patient monitoring included vital signs, laboratory tests, and recording of the incidence and duration of adve rse events. To evaluate efficacy, postcontrast T1-weighted images were compared with precontrast T1- and T2-weighted images. Investigators h aving clinical information evaluated 129 studies for efficacy; two rea ders blinded to clinical information subsequently evaluated 122 studie s using the same criteria as the investigators. RESULTS: Eight patient s (6.0%) experienced mild adverse events possibly or probably related to contrast administration, all of which resolved without treatment. T wo clinically significant laboratory abnormalities considered related or possibly related to the administration of gadoteridol were reported in two patients. Enhancement of pathology was seen in 82.9% of cases evaluated by investigators at the study site and in 78.7% of cases sub sequently evaluated by the blinded readers. Postcontrast images were j udged by investigators to provide additional diagnostic information ov er precontrast images in 68.9% of studies. The additional diagnostic i nformation available on postcontrast studies most often consisted of i mproved visualization of pathology and better definition of lesion bor ders. The use of this information might have contributed to a change i n patient diagnosis in 18.6% of the cases evaluated by the investigato rs and in 16.4% of the cases reviewed by the blinded readers. CONCLUSI ONS: Preliminary results show gadoteridol to be a safe and efficacious contrast agent for enhanced MR study of extracranial and extraspinal head and neck pathology.