Abstract
In order to evaluate the safety and efficacy of a high-dose gadodiamide injection a phase-III trial was conducted using a dose of 0.3 mmol Gd/kg bw in patients with known or suspected tumors in the head and neck 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 T1- and T2-weighted sequences. A FATSAT sequence was also applied. After i. v. contrast administration T1-weighted scans were obtained. Efficacy was evaluated by means of a comparison of the pre- and postcontrast images. Postcontrast images gave more diagnostic information compared with precontrast images, which facilitated diagnosis in all patients. In 8 patients T1-weighted postcontrast images revealed abnormal structures 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 examination of tumors in the head and neck region. Use of the contrast medium increased the diagnostic information in the images and increased the confidence in making the diagnosis.
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Vogl, T.J., Western, A., Mack, M.G. et al. MR imaging of head and neck lesions using high-dose gadodiamide injection: a phase III clinical trial. Eur. Radiol. 5, 609–614 (1995). https://doi.org/10.1007/BF00190926
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DOI: https://doi.org/10.1007/BF00190926