Bogdahn, Ulrich and Hoelscher, Thilo and Rosin, Ludger and Goetz, Birgit and Schlachetzki, Felix (1999) Contrast-enhanced transcranial and extracranial duplex sonography: Preliminary results of a multicenter phase II/III study with SonoVue (TM). ECHOCARDIOGRAPHY-A JOURNAL OF CARDIOVASCULAR ULTRASOUND AND ALLIED TECHNIQUES, 16 (7). pp. 761-766. ISSN 0742-2822,
Full text not available from this repository. (Request a copy)Abstract
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(TM) Patients were studied with standard color duplex systems. SonoVue(TM) 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 mi of SonoVue(TM) 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. SonoVue(TM) 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.
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | REAL-TIME SONOGRAPHY; ultrasound contrast agents; SonoVue (TM) (BR1); transcranial color-coded duplex sonography; signal-to-noise ratio |
| Subjects: | 600 Technology > 610 Medical sciences Medicine |
| Divisions: | Medicine > Lehrstuhl für Neurologie |
| Depositing User: | Dr. Gernot Deinzer |
| Date Deposited: | 20 Dec 2022 09:50 |
| Last Modified: | 20 Dec 2022 09:50 |
| URI: | https://pred.uni-regensburg.de/id/eprint/48943 |
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