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 contrast agent in patients with suspected head and neck pathology.

Methods: One hundred thirty-three adult patients were studied with MR at 12 clinical trial sites before and after the intravenous administration of 0.10 mmol/kg gadoteridol. After enrollment, patients underwent a complete physical examination. Patient monitoring included vital signs, laboratory tests, and recording of the incidence and duration of adverse events. To evaluate efficacy, postcontrast T1-weighted images were compared with precontrast T1- and T2-weighted images. Investigators having clinical information evaluated 129 studies for efficacy; two readers blinded to clinical information subsequently evaluated 122 studies using the same criteria as the investigators.

Results: Eight patients (6.0%) experienced mild adverse events possibly or probably related to contrast administration, all of which resolved without treatment. Two 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 subsequently evaluated by the blinded readers. Postcontrast images were judged by investigators to provide additional diagnostic information over precontrast images in 68.9% of studies. The additional diagnostic information available on postcontrast studies most often consisted of improved visualization of pathology and better definition of lesion borders. The use of this information might have contributed to a change in patient diagnosis in 18.6% of the cases evaluated by the investigators and in 16.4% of the cases reviewed by the blinded readers.

Conclusions: Preliminary results show gadoteridol to be a safe and efficacious contrast agent for enhanced MR study of extracranial and extraspinal head and neck pathology.