EFFICACY AND SAFETY OF GADOPENTETATE DIMEGLUMINE IN THE EVALUATION OF PATIENTS WITH A SUSPECTED TUMOR OF THE EXTRACRANIAL HEAD AND NECK

The clinical efficacy and safety of gadopentetate dimeglumine as a paramagnetic contrast agent for magnetic resonance (MR) imaging of the extracranial head and neck was evaluated in a multicenter trial involving 60 patients. Patients with signs and /or symptoms of a tumor in the nasopharynx, oropharynx, hypopharynx, larynx, or neck were studied. TI-weighted images were obtained before and after injection of gadopentetate dimeglumine, 0. 1 mmol/kg, at a rate of 1 0 mL/min. No lesions were seen on the pre- or postinjection images of five of the 60 patients. Postinjection lesion enhancement was present in 53 of the remaining 55 (96%) patients. The absence of postinjection lesion enhancement in one of the two remaining patients was useful information. Postinjection impressions differed from preinjection diagnosis in 22 of 60 (37%) patients. Additional information was obtained from postinjection relative to preinjection images in 38 of 60 (63%) patients. Four adverse experiences were reported in three of 60 (5%) patients. Two mild (chest wall pain and headache) and one moderate (nausea) adverse experiences were considered by the authors to be unrelated to the studied drug. One severe adverse experience was reported. This patient had a seizure, considered by the investigator to be remotely related to the study drug and attributed to the abrupt withdrawal of anticonvulsant medications. The data indicate that gadopentetate dimeglumine is safe and efficacious in the evaluation of patients with extracranial head and neck lesions.