SonoVue (TM) in transcranial Doppler investigations of the cerebral arteries

Background and Purpose. The authors investigated the safety and diagnostic potential of a new ultrasound contrast agent (SonoVue(TM)) using transcrani al color-coded duplex sonography (TCCS). Methods. Forty patients were enrol led in a multicenter, open-label (on-site), blind (off-site), randomized, d ose-ranging crossover study. SonoVue(TM) was administered as an intravenous bolus injection of 4 different dosages (0.3, 0.6, 1.2, and 2.4 mL). Effica cy was evaluated as (1) off-site assessment of global quality of the Dopple r investigation (based on color or power Doppler images and spectral analys is) at baseline and following each dose of SonoVue(TM) according to a 4-poi nt scale (from very poor to excellent imaging of blood flow) and (2) durati on of clinically useful signal enhancement and color or power Doppler visua lization of blood flow. Additional on-site efficacy assessments performed f ollowing each dose of SonoVue(TM) included confidence in diagnosis and glob al consequences of contrast enhancement on diagnosis. Safety evaluations in cluded 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(TM) significantly improved the global quality of Doppler examinations (P < .05). The median duration of cl inically useful enhancement was dose related (P < .001) and ranged from 2 t o 6 minutes at the highest dose. The administration of the contrast agent c hanged a nondiagnostic study to a diagnostic one in 66% of patients and inc reased the confidence in diagnosis in 74% of cases. No serious adverse even ts were recorded following SonoVue(TM) administration. The observed adverse reactions were all transient and mild in intensity. Conclusions. The resul ts obtained from this multicenter study demonstrate that the administration of SonoVue(TM) to patients with ischemic cerebrovascular disease who under go TCCS examination of cerebral vessels improves the visualization of intra cranial arteries, providing a dose-dependent contrast enhancement and a cli nically useful duration of signal enhancement related to the dose. During t his multicenter study, SonoVue(TM) proved to be a safe and well-tolerated c ompound.