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 gadolinium chelate Gadovist 1.0 for assessment of cerebral hemodynamics with dynamic susceptibility contrast-enhanced magnetic resonance (MR) imaging. Eighty-nine patients with carotid artery stenosis or cerebral infarcts were included in this multicenter, double-blinded study using five dose groups from 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 quantitative and qualitative parameters describing signal-time curves and relative regional cerebral blood volume maps were investigated. For safety evaluation, vital signs, clinical and laboratory tests, and adverse events were 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. J. Magn. Reson. Imaging 2000;12:371-380. Copyright 2000 Wiley-Liss, Inc.

RCT Entities:   Population Interventions Outcomes