Journal of neuroimaging : official journal of the American Society of Neuroimaging
-
Multicenter Study
Preliminary MRI quality assessment and device acceptance guidelines for a multicenter bioclinical study: the GO Glioblastoma Project.
It is a major challenge to guarantee homogeneous acquisition during a prospective multicenter magnetic resonance imaging (MRI) study that makes use of different devices. The goal of the multicenter Grand Ouest Glioblastoma Project (GOGP) was to correlate MRI quantitative parameters with biological markers extracted from image-guided biopsies. Therefore, it was essential to ensure spatial coherence of the parameters as well as the signal intensity and homogeneity. ⋯ A fourth test-object was used to assess T1 accuracy. Although geometry-related parameters, signal-to-noise ratio, uniformity, and T1 measurements varied slightly depending on the different devices, they nevertheless remained within the recommendations and expectations of the multicenter project. This kind of quality control procedure should be undertaken as a prerequisite to any multicenter clinical project involving quantitative MRI and comparison of data acquisitions with quantitative biological image-guided biopsies.
-
Review Multicenter Study
Endovascular management of symptomatic extracranial stenosis associated with secondary intracranial tandem stenosis. A multicenter review.
Several studies have reported variable rates of perioperative risk of stroke in individuals with tandem stenoses after carotid endarterectomy. Endovascular treatment of extracranial lesions associated with tandem lesions is limited to case reports and small case series. ⋯ The high risk of postprocedural stroke and/or death observed in this series requires careful assessment of the risk/benefit ratio of endovascular procedures in patients with tandem stenosis.
-
Multicenter Study Clinical Trial
Intra-arterial tenecteplase for treatment of acute ischemic stroke: feasibility and comparative outcomes.
Tenecteplase (TNK) is a third-generation thrombolytic agent. We evaluated the safety and feasibility of intra-arterial (IA) administration of TNK in patients with acute ischemic stroke. ⋯ Our study demonstrates that administration of IA TNK in acute stroke is safe and results in rates of favorable outcomes that are comparable to those observed with currently used drugs. Additional studies are needed to further determine the safety and efficacy of IA TNK in acute stroke treatment.
-
Randomized Controlled Trial Multicenter Study Comparative Study Clinical Trial
CLOTBUST: design of a randomized trial of ultrasound-enhanced thrombolysis for acute ischemic stroke.
Intravenous tissue plasminogen activator (TPA) therapy can be monitored with 2 MHz transcranial Doppler (TCD). This article describes the design of CLOTBUST (combined lysis of thrombus in brain ischemia using transcranial ultrasound and systemic TPA), the first prospective international multicenter randomized clinical trial of noninvasive externally applied ultrasound to enhance systemic thrombolysis in human stroke. ⋯ The aim of phase II CLOTBUST trial is to determine the rates of early complete recanalization and dramatic/early clinical recovery in TPA + TCD and TPA groups. The sample size is set at 126 patients since a medium effect size (.50) is anticipated for TPA + TCD group vs TPA alone to achieve combined primary end-point.
-
Multicenter Study Clinical Trial Controlled Clinical Trial
Transcranial duplex imaging with a sulfurhexafluoride echocontrast agent: enhancement and diagnostic quality.
The authors investigate characteristics of ultrasound enhancement and diagnostic quality of a sulfurhexafluorides (SF6)-containing echocontrast agent (SonoVue) in cerebrovascular patients with insufficient temporal bone window by transcranial color-coded duplex (TCCD) sonography. ⋯ Administration of SonoVue led to a quality improvement in 21 patients. In TCCD, it optimizes visualization of the cerebral arteries in patients with inadequate bone window. A dose of at least 1.2 mL provides the best enhanced images.