MRI staging using gadodiamide for soft-tissue tumors of the head and neck region. Results from a phase II trial and a 5-year clinical follow-up

In order to document the safety, tolerability and efficacy of gadodiamide o utside CNS, an open, non-drug comparative study was performed in patients w ith tumors of the head and neck region. Fifty adult patients were included and 48 patients received the contrast medium. The examinations were perform ed on a 1.5 T imager using transverse. non-enhanced T1- and PD-/T2-weighted conventional spin-echo sequences, followed by a contrast-enhanced transver se T1-weighted sequence. Post-contrast images provided more diagnostic info rmation compared to unenhanced images in 33 of 48 patients (69%). This info rmation was of significant help in four and of moderate help in 14 cases. P ost-contrast images compared to non-enhanced TI-weighted showed improvement in lesion delineation for 29 of the 43 patients where a lesion was observe d. Only in two patients was the diagnostic information lower post-contrast. A comparison between all pre-contrast images versus contrast medium enhanc ed showed post-contrast images to give more diagnostic information in 14 an d less in nine patients. No patient experienced discomfort in relation to g adodiamide injection. Only one adverse event occurred which was described a s thirst, being of moderate intensity. The 5-year clinical outcome was anal yzed and compared with the pre-operative staging. The case-books of till pa tients were reviewed and in 44 patients all information could be found. Of those, 18 were still alive, one with active disease (AAD) and 17 with no ev idence of disease (NED). Two of those four patients, where information was incomplete, showed NED and two had died. This trial showed that contrast-en hancement using gadodiamide for evaluation of soft tissue tumors in the hea d and neck region was safe and provided statistically significant more diag nostic information compared with unenhanced images. MRI, when compared with palpation/inspection, changed tumor staging in approximate to 30% of all c ases. (C) 2001 Elsevier Science Ireland Ltd. All rights reserved.