Contrast-Enhanced Transcranial and Extracranial Duplex Sonography: Preliminary Results of a Multicenter Phase II/III Study with SonoVuetrade mark.
Transcranial sonography is an ultrasonographic application with real problems of insufficient signal to noise ratio, which make it a primary candidate for applying ultrasonographic contrast enhancing agents. Within an international randomized multicenter phase II/III study, we investigated ten patients with insufficient Doppler signal retrieval using transcranial and extracranial color-coded duplex sonography to define safety, toxicity, optimal dosing, and the potential of the new ultrasound contrast agent SonoVue(trade mark). Patients were studied with standard color duplex systems. SonoVue(trade mark) was administered by IV bolus injection at four different doses. Efficacy parameters included the assessment of global quality of Doppler investigations, color Doppler (CD), and spectral Doppler (SD) evaluated by semiquantitative analysis using a four-point scale from 0 to 3 (very poor to excellent) and the duration of clinically useful signal enhancement. In addition, CD enhancement, evaluated at best signal enhancement, was assessed using a five-point scale, from no enhancement, slight, moderate, optimal to excessive (0-4). All examinations were compared to "gold" standard imaging (magnetic resonance imaging, digital subtraction angiography) to evaluate diagnostic confidence at optimum dosage. No serious adverse events were observed. Mean signal increase over baseline in CD or SD was 2 out of 4 points. Mean time to appearance of contrast enhancement was 22.8 seconds (9-52 sec) at the optimal dosage. The mean duration of enhancement was 281 seconds(20-593 sec) at the optimal dosage, which was of 2.4 ml of SonoVuetrade mark in nine patients. CD and SD signal enhancement (n = 20, CD + SD) was considered optimal in 12 of 20, excessive in 1 of 20, and moderate or insufficient in 5 of 20 and 2 of 20 cases, respectively. There was a tendency for superior improvement in CD signal enhancement. Diagnostic confidence was improved in 8 of 10 cases without false diagnostic conclusions. SonoVuetrade mark has been demonstrated to be a powerful and safe echo signal enhancing agent, which significantly improves transcranial and extracranial ultrasound investigations and increases the confidence in diagnosis.
Bogdahn
Ulrich
U
Department of Neurology, University of Regensburg, Universitätsstr. 84, D-93053 Regensburg, Germany.
Hölscher
Thilo
T
Rosin
Ludger
L
Götz
Birgit
B
Schlachetzki
Felix
F