Current Status and Prospectives of CEUS in Taiwan

Abstract

The clinical experiences of Levovist (Schering AG, Germany) in Taiwan (1996) were promising in the characterization of focal liver tumors. Although effective in the application in various organs, Levovist has certain shortcomings, e.g., shorter longevity of the echo-enhancing effect and incapability of being satisfactorily with harmonic imaging techniques with these limitations. Levovist was withdrew from Taiwan market in 2003. Since there was a general consensus that contrast-enhanced US (CEUS) may facilitate an accurate US diagnosis and can overcome the limitation of conventional US imaging, it was believed CEUS should be introduced to Taiwan. SonoVue, Definity, and Sonazoid are three of the more successful contrast agents in the past 10-15 years. SonoVue have been widely used in Europe and parts of Asia and Sonazoid is now in the process to obtain approval to be used in Asian countries out of Japan, Korea, and Taiwan, as well as America. Definity is now in the process to get approval in Taiwan. Other echopharmaceuticals are now designed to change the attenuation or impedance of sound for enhancing the differentiation of signals of a target organ from that of the surrounding tissue. During the past 9 years, a lot of efforts have been made to introduce USCA into the Taiwan healthcare community. In order to conduct a pilot study to convince Taiwan Food and Drug Administration (TFDA) for the possible approval of USCA to be used in Taiwan, three manufacturers (SonoVue, Sonazoid, and Definity) were invited to survey the Taiwan market. Finally, GE Healthcare got the first chance to convince the subcommittee of USCA (under the umbrella of Commission of Research and Development of Medical Ultrasound, Chinese Taipei Society of Ultrasound in Medicine, CTSUM). And Sonazoid was the priority agent accepted by CTSUM. We expect with the wide applications of USCA in Taiwan, more experience can be accumulated. The subcommittee of USCA with its 40 committee members subspecialized in different fields (e.g., gastroenterology, gynecology, cardiovascular, small parts, neurology, pediatric, etc.) will conduct more studies to find out other utilities of CEUS to benefit patients.