CEUS Stakeholder Portals
Contrast enhanced ultrasound (CEUS) is a safe and versatile imaging technique used worldwide for numerous applications throughout the body. CEUS has been approved by the US Food and Drug Administration (FDA) for cardiac applications involving since 1997 and for liver and pediatric applications since 2016. In Europe, additional approved uses include the detection and characterization of breast masses as well as Doppler enhancement and the assessment of vasculature. Off-label uses are also common and widely accepted worldwide, with some reimbursement permitted (e.g., CEUS imaging of the kidney and bladder in the US).
CEUS uses ultrasound contrast agents (UCAs), sometimes also known as ultrasound enhancement agents, to improve the clarity of ultrasound images or to better characterize focal lesions or structures of organs. UCAs are injected intravenously during an ultrasound examination. They are comprised of liquid suspensions of biocompatible gas-filled microspheres (“microbubbles”) that are smaller than red blood cells, with a heavy gas mixture encapsulated by a phospholipid or protein shell. When UCAs interact with an ultrasound beam they allow characterization of enhancement patterns.
Unlike iodine contrast agents used for CT or gadolinium contrast agents used for MR, microbubble contrast agents used for ultrasound are pure blood agents with no interstitial or intracellular passage. This property in combination with the extraordinary spatial and temporal resolution allows UCAs to display enhancement patterns that are unique for the characterization of tissue.
Microbubbles are a safe and valuable diagnostic option for patients with allergies to other contrast agents, patients with renal insufficiency, and when avoidance of radiation by CT or exposure to magnetic fields in MR is a priority. UCAs are not excreted by the kidneys but are cleared mainly through the lungs; accordingly, they present no nephrotoxic potential. In addition they carry a lower risk for allergic reactions than iodine and gadolinium agents. Further, unlike CT or MR, ultrasound is portable and may be used at the patient’s bedside, in the interventional suite or in the operating room.
CEUS imaging requires intravenous access for administration of the agent and specific software for detection; this software is available from many ultrasound vendors as an option for their intermediate and high-end ultrasound systems. However, there are generally no other CEUS requirements other than customary patient preparation for the specific ultrasound application (e.g., avoidance of solid food prior to liver imaging).
Numerous studies have shown that CEUS images are of similar utility to, and indeed may be superior to, alternative imaging for the characterization of focal lesions in organs such as the liver or kidney.
Therapeutic applications of UCA microbubbles are in development. These applications include targeted drug and gene delivery, sonothrombolysis and other applications related to cavitation and to the transient nature of the UCAs when interacting with the ultrasound pulse.
For publications on specific topics please refer to the various bibliography sections.
Ultrasound contrast agents (UCAs), also known as ultrasound enhancement agents, are among the most valuable tools available to the medical or cardiac sonographer. UCAs significantly improve ultrasound image quality, increasing the reliability of echocardiograms as well as the physician’s ability to identify and characterize, focal lesions, tumors and abnormalities in blood vessels of various organs. UCAs also can reduce the need for additional or alternative testing, saving costs and precious time for the sonographer, medical team and patient.
UCAs are comprised of liquid suspensions of biocompatible gas-filled microspheres (“microbubbles”) that are smaller than red blood cells, with a heavy gas mixture encapsulated by a phospholipid or protein shell. When UCAs interact with an ultrasound beam they allow characterization of enhancement patterns.
Contrast enhanced ultrasound (CEUS) exams require intravenous access for injection and specific software for detection of the contrast agent. This software is available from many ultrasound vendors as an option for their intermediate and high-end ultrasound systems.
Sonographers often play an important role in administering CEUS to patients in a variety of clinical settings. Medical and cardiac sonographers are qualified to perform contrast injections when credentialed or certified to do so. Nonetheless, primarily in the US, some medical centers insist that a registered nurse be called to establish venous access and to administer the agent even when available sonographers have the appropriate education, certifications, clinical experience, and demonstrated competency. At those centers, when nurses are not available, patients are effectively denied access to medically indicated CEUS. This can negatively impact patient care, and if further testing is ordered patients may incur unnecessary additional costs, delays, and exposure to ionizing radiation.
ICUS policy (below) supports scope of practice policies and procedures that permit qualified sonographers to gain peripheral venous access and administer UCAs when medically indicated.
SCOPE OF PRACTICE
- International Contrast Ultrasound Society: ICUS Policy Statement on Role of Sonographer
- Society of Diagnostic Medical Sonographers: Scope of Practice and Clinical Standards for the Diagnostic Medical Sonographer
- American Society of Echocardiography: Contrast Zone
- The Intersocietal Accreditation Commission (IAC): Echocardiography Standards and Guidelines
PUBLICATIONS – Cardiovascular
- Agents in Echocardiography: 2018 American Society of Echocardiography Guidelines Update
- American Society of Echocardiography Guidelines and Recommendations for Contrast Echocardiography: A Summary for Applications Approved by the U.S. Food and Drug Administration
- Guidelines for the Cardiac Sonographer in the Performance of Contrast Echocardiography
PUBLICATIONS – Body Imaging
The positive patient results emerging from over two decades of Contrast Enhanced Ultrasound (CEUS) use is invigorating the healthcare industry with innovative ways to think about improving patient imaging and experiences while also reducing healthcare costs. A new generation of healthcare leaders is now equipped with the knowledge of the benefits of CEUS for achieving new standards of excellence.
UCAs are approved in more than 70 countries for use in diagnosing a wide variety of medical abnormalities of the heart, liver, gastrointestinal tract, kidneys, and other organ systems. At present, the following UCAs are available for a variety of indications in various countries:
- Definity (Lantheus Medical Imaging)
- Lumason, also marketed outside the United States as Sonovue (Bracco Diagnostics)
- Optison (GE Healthcare)
- Sonazoid (GE Healthcare)
ICUS policy statement endorsing sonographer administration of CEUS
Contrast Enhanced Ultrasound (CEUS) is an “enhanced” ultrasound exam that safely and inexpensively images cancers and serious medical conditions throughout the body, without radiation or contrast dyes.
Whether you or someone you love is considering or receiving a CEUS test, knowing what to expect is important to making an informed decision. This website provides basic information about CEUS and its uses, in addition to in-depth information and references on the clinical safety and cost effectiveness of these procedures.
CEUS uses an ultrasound “contrast agent” (UCA), sometimes also known as an “enhancement agent,” to improve the clarity and reliability of an ultrasound image.
These agents are not like the typical contrast agents used in other forms of diagnostic imaging, since UCAs do not contain contrast dyes or radioactive compounds, are not known to harm the kidneys, and have no known side effects except for rare allergic reactions. There is a particular interest in using CEUS is children because it is well tolerated, does not require sedation and does not expose these vulnerable patients to radiation.
UCAs are made of solutions containing tiny microbubbles that are smaller than red blood cells. UCAs are injected into an arm vein during the ultrasound exam. As the microbubbles flow through the bloodstream, they reflect ultrasound waves and light up the image seen on a television-like screen. . They are metabolized and expelled from the body, primarily through the lungs, within minutes.
UCAs are used in echocardiography to give healthcare professionals a better picture of the structure of the heart, assess cardiac perfusion, and evaluate obstructions in carotid arteries leading to the brain. In addition, UCAs are used in radiology (body ultrasound imaging) to assess masses in the liver, kidneys and other organs that are suspicious for cancer or infection. They also may be used to monitor therapy in patients with a variety of medical conditions.