Lennard Greenbaum

Contrast-Enhanced Ultrasound: What Is the Evidence and What Are the Obstacles?

OBJECTIVE Although ultrasound contrast agents (UCAs) are popular and widely used in Europe and Asia, the U.S. Food and Drug Administration (FDA) has not approved a microbubble agent for radiology imaging in the United States. Herein, we discuss the evidence for and the obstacles to using UCAs for contrast-enhanced ultrasound (CEUS). CONCLUSION Despite the obstacles to the use of UCAs for CEUS including regulatory and practice patterns, the evidence indicates that radiologists and patients will be missing an effectual imaging option if we do not encourage the use of CEUS and strongly support the approval of UCAs by the FDA. The evidence outweighs the obstacles: CEUS is cost-effective; can be performed at the bedside; uses no ionizing radiation; has no nephrotoxicity; and, most importantly, can provide accurate diagnostic information comparable to CT and MRI.

American Institute of Ultrasound in Medicine Recommendations for Contrast-Enhanced Liver Ultrasound Imaging Clinical Trials

Received January 25, 2007, from Orlando Regional Healthcare, Orlando, Florida USA (L.G.); Sunnybrook Health Sciences Center, Toronto, Ontario, Canada (P.B.); Yale University School of Medicine, New Haven, Connecticut USA (J.C.); Hammersmith Hospital, London, England (D.C.); University of Michigan Health System, Ann Arbor, Michigan (J.B.F.); Thomas Jefferson University Hospital, Philadelphia, Pennsylvania USA (B.G., D.M.); University of California San Diego Medical Center, San Diego, California USA (R.M.); University of Alabama at Birmingham, Birmingham, Alabama USA (M.R.); and University of Toronto, Toronto, Ontario, Canada (S.W.). Manuscript accepted for publication January 29, 2007. These recommendations were developed by the AIUM in consultation with the following companies: Bracco Imaging SpA, Bristol-Myers Squibb Medical Imaging, GE Healthcare, National Electrical Manufacturers Association, Philips Medical Systems Ultrasound, Siemens Medical Solutions, Inc, and SonoSite. The AIUM acknowledges these companies for the background that they provided; it was essential to the development of this document. Address correspondence to Lennard Greenbaum, MD, Winnie Palmer Hospital for Women & Babies, The Hughes Center for Fetal Diagnostics, 83 W Miller St, Orlando, FL 32806 USA. E-mail: lengreenbaum@msn.com Abbreviations AIUM, American Institute of Ultrasound in Medicine; ALARA, as low as reasonably achievable; CEUS, contrast-enhanced ultrasound; CT, computed tomographic; FDA, Food and Drug Administration; MI, mechanical index; MR, magnetic resonance; PVC, premature ventricular contraction Preamble

Foreword to Guidelines and Good Clinical Practice Recommendations for Contrast Enhanced Ultrasound (CEUS) in the Liver – Update 2012

Correspondence Lennard D. Greenbaum Winnie Palmer Hospital for Women & Babies Orlando, The Hughes Center for Fetal Diagnostics 83 West Miller Street Orlando, FL 32806 USA lengreenbaum@me.com Tel.: ++ 1/4 07/6 4969 10 The European Federation of Societies for Ultrasound in Medicine and Biology (EFSUMB) deserves our thanks for recognizing the need for ultrasound contrast agent (UCA) guidelines and for writing and publishing them in 2004 [1] and 2008 [2]. The third iteration of UCA guidelines in the liver, Guidelines and Good Clinical Practice Recommendations for Contrast Enhanced Ultrasound (CEUS) in the Liver – Update 2012, contains major changes from the two previous versions. In the 2012 guideline, EFSUMB acknowledges the almost worldwide acceptance and usage of CEUS in the liver. A major change is the fact that this new guideline is a collaborative document with the participation of World Federation for Ultrasound in Medicine and Biology (WFUMB), Asian Federation of Societies for Ultrasound in Medicine and Biology (AFSUMB), American Institute of Ultrasound in Medicine (AIUM), Australasian Society for Ultrasound in Medicine (ASUM) and International Contrast Ultrasound Society (ICUS). This is the first time that experts from around the world in the non-cardiac use of CEUS have come together to create a unified guideline on its use. This international participation gives the document more strength and proclaims the worldwide recognition of the use of CEUS to image the liver. The 2012 guideline begins with a most appreciated “List of Abbreviations,” which provides easy access for reference. There also is a new section on “Terminology,” which includes contributordefined descriptive terms that should be used when reporting and publishing CEUS findings, including a newer contrast agent that has a postvascular phase. Having worldwide agreement on terminology greatly improves communication of results. Utilizing this terminology, a most significant change in this guideline is a marked expansion of the description of various liver lesions and how they appear on contrast-enhanced images. The section on Safety Considerations has been brought up to date citing several new papers confirming the excellent safety profile of UCAs. The bulk of the guideline is divided into sections dealing with characterization of focal liver lesions (FLL) (subdivided into noncirrhotic and cirrhotic livers), characterization of portal vein thrombosis, the use of CEUS when performing a biopsy, detection of FLL, using CEUS intraoperatively, monitoring ablation treatment, evaluating liver transplants and monitoring systemic treatment of malignancies. This guideline should be a major reference for anyone performing CEUS of the liver. Hopefully, here in the United States, we will have approval by our Food and Drug Administration in the foreseeable future and will be able to put this excellent guideline to use.