SonoVue in transcranial Doppler investigations of the cerebral arteries.
OBJECTIVE
The authors investigated the safety and diagnostic potential of a new ultrasound contrast agent (SonoVue) using transcranial color-coded duplex sonography (TCCS).


METHODS
Forty patients were enrolled in a multicenter, open-label (on-site), blind (off-site), randomized, dose-ranging crossover study. SonoVue was administered as an intravenous bolus injection of 4 different dosages (0.3, 0.6, 1.2, and 2.4 mL). Efficacy was evaluated as (1) off-site assessment of global quality of the Doppler investigation (based on color or power Doppler images and spectral analysis) at baseline and following each dose of SonoVue according to a 4-point scale (from very poor to excellent imaging of blood flow) and (2) duration of clinically useful signal enhancement and color or power Doppler visualization of blood flow. Additional on-site efficacy assessments performed following each dose of SonoVue included confidence in diagnosis and global consequences of contrast enhancement on diagnosis. Safety evaluations included clinical laboratory tests, neurological examination, injection site tolerability, and incidence of adverse events and their relationship to the study agent.


RESULTS
All doses of SonoVue significantly improved the global quality of Doppler examinations (P < .05). The median duration of clinically useful enhancement was dose related (P < .001) and ranged from 2 to 6 minutes at the highest dose. The administration of the contrast agent changed a nondiagnostic study to a diagnostic one in 66% of patients and increased the confidence in diagnosis in 74% of cases. No serious adverse events were recorded following SonoVue administration. The observed adverse reactions were all transient and mild in intensity.


CONCLUSIONS
The results obtained from this multicenter study demonstrate that the administration of SonoVue to patients with ischemic cerebrovascular disease who undergo TCCS examination of cerebral vessels improves the visualization of intracranial arteries, providing a dose-dependent contrast enhancement and a clinically useful duration of signal enhancement related to the dose. During this multicenter study, SonoVue proved to be a safe and well-tolerated compound.
Kaps
M
M
Department of Neurology, Medical Centre of Neurology and Neurosurgery, Justus-Liebig-University of Giessen, Am Steg 14, D-35385 Giessen, Germany. manfred.kaps@neuro.med.uni-giessen.de
Legemate
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Ries
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Ackerstaff
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Markus
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Pezzoll
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Llull
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Spinazzi
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D000704:Analysis of Variance; D001783:Blood Flow Velocity; D002560:Cerebrovascular Circulation; D002561:Cerebrovascular Disorders / Q000000981:diagnostic imaging*; D003287:Contrast Media / Q000008:administration & dosage*; D018592:Cross-Over Studies; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010743:Phospholipids / Q000008:administration & dosage*; D018709:Statistics, Nonparametric; D013459:Sulfur Hexafluoride / Q000008:administration & dosage*; D017585:Ultrasonography, Doppler, Transcranial; D014743:Videotape Recording
D003287:Contrast Media; D010743:Phospholipids; C420843:contrast agent BR1; D013459:Sulfur Hexafluoride