MR-IMAGING OF HEAD AND NECK LESIONS USING HIGH-DOSE GADODIAMIDE INJECTION - A PHASE-III CLINICAL-TRIAL

In order to evaluate the safety and efficacy of a high-dose gadodiamid e injection a phase-III trial was conducted using a dose of 0.3 mmol G d/kg bw in patients with known or suspected tumors in the head and nec k region. A total of 90 in- and outpatients referred to MR examination for tumor in the head and neck area were included. Precontrast images consisted of T-1- and T-2-weighted sequences. A FATSAT sequence was a lso applied. After i.v. contrast administration T-1-weighted scans wer e obtained. Efficacy was evaluated by means of a comparisons of the pr e- and postcontrast images. Postcontrast images gave more diagnostic i nformation compared with precontrast images, which facilitated diagnos is in all patients. In 8 patients T-1-weighted post contrast images re vealed abnormal structure not seen on precontrast images and no lesion was obscured by the contrast medium. Gadodiamide injection at a dose of 0.3 mmol GD/kg bw was judged as safe and effective for the examinat ion of tumors in the head and neck region. Use of the contrast medium increased the diagnostic information in the images and increased the c onfidence in making the diagnosis.