PIO 7707 The use of microbubble contrast angiography in monochorionic twin fetuses: Work in progress

✍ Scribed by M. Denbow; M. Blomley; D. Cosgrove; N. Fisk

• Book ID: 104325223
• Publisher: Elsevier Science
• Year: 1997
• Tongue: English
• Weight: 143 KB
• Volume: 23
• Category: Article
• ISSN: 0301-5629
• DOI: 10.1016/s0301-5629(97)80813-7

✦ Synopsis

Purpose: To present clinical pharmacology of Sonovue (BRl) a new contrast medium (CM) for ultrasound imaging. Methods: Ninety-eight healthy volunteers in five single-or repeateddose phase I trials (two placebo-controlled). Sonovue doses from 0.003 (single) to 0.6 mlikg bw (cumulative of three consecutive doses). Efficacy evaluation: improvement of B-mode signal in cardiac and of Doppler signal in extracardiac studies. Safety assessments: adverse events (AEs) and safety parameters (subjective/ physical observations, vital signs, 9 saturation, Halter ECG and echocardiography, Mini-Mental State test, visual acuity, pre-and post-CM laboratory tests) monitored up to 24-72 hours post-dosing. Tolerance evaluated as patient discomfort associated with CM injection. Results: Sonovue always passed through the pulmonary circulation and improved left ventricle endocardibl .border defmition and Doppler signal in different vascular districts. No serious AEs were recorded. The non-serious AEs were transient, mild in intensity and unrelated to CM. No clinically significant changes in safety parameters were observed. Conclusions: Under the conditions tested, Sonovue is a safe and effective CM for ultrasound imaging.