Cerebral MR perfusion imaging: First clinical application of a 1 M gadolinium chelate (Gadovist 1.0) in a double-blinded randomized dose-finding study

The purpose of this study was to evaluate efficacy and safety of the 1 M ga dolinium chelate Gadovist 1.0 for assessment of cerebral hemodynamics with dynamic susceptibility contrast-enhanced magnetic resonance (AM) imaging. E ighty-nine patients with carotid artery stenosis or cerebral infarcts were included in this multicenter, double-blinded study using five dose groups f rom 0.1 to 0.5 mmol/kg. Imaging was performed with 1-T scanners using a T2* -weighted fast low-angle shot (FLASH) sequence. Dose-dependent changes in q uantitative and qualitative parameters describing signal-time curves and re lative regional cerebral blood volume maps were Investigated. For safety ev aluation, vital signs, clinical and laboratory tests, and adverse events we re assessed. The quantitative measurements revealed an optimal dose of 0.4 mmol/kg. The qualitative evaluation revealed that the required qualitative assessment for clinical purposes was already reached at a dose of 0.3 mmol/ kg. No significant changes in vital signs and laboratory tests were found. No serious adverse events were observed. The combined results revealed the dose of 0.3 mmol/kg as the diagnostically adequate dose given the gradient- echo sequence and field strength used. Gadovist 1.0 has been shown to be a safe and well-tolerated contrast agent. (C) 2000 Willey-Liss, Inc.