News | Contrast Media | May 11, 2021

Medical Societies Support Safety and Benefits of Ultrasound Contrast Agents

The American Institute of Ultrasound in Medicine (AIUM) and the American Society of Echocardiography (ASE) have joined the International Contrast Ultrasound Society (ICUS) in recognizing the relatively low risk and important clinical benefits of ultrasound contrast agents (UCAs), which are used routinely around the world to help detect heart disease, stratify the risk of heart attack or stroke, identify and characterize tumors throughout the abdomen, and monitor the effectiveness of cancer therapies in adul

May 11, 2021 — The American Institute of Ultrasound in Medicine (AIUM) and the American Society of Echocardiography (ASE) have joined the International Contrast Ultrasound Society (ICUS) in recognizing the relatively low risk and important clinical benefits of ultrasound contrast agents (UCAs), which are used routinely around the world to help detect heart disease, stratify the risk of heart attack or stroke, identify and characterize tumors throughout the abdomen, and monitor the effectiveness of cancer therapies in adults and children.

All three medical societies issued statements reacting to a recent communication from the Food and Drug Administration “stakeholder engagement staff” citing 13 suspected adverse reactions to polyethylene glycol (PEG), an inactive ingredient in two UCAs, without mentioning that reactions to UCAs are extremely rare and the 13 cases at issue were drawn from historical data representing millions of doses of UCAs administered over more than a decade.

In addition, there was no apparent confirmation or data to show whether the 13 suspected reactions were caused by other conditions or exposures.

Noting that UCAs “provide very substantial benefits to our patients” the AIUM statement recommends no change to clinical policy regarding use of UCAs other than asking patients if they have a PEG allergy.

“Reactions to PEG, although extremely rare, need to be considered alongside the clear benefits of contrast-enhanced ultrasound (CEUS),” the AIUM statement said.

The ASE Expert Consensus Statement similarly concluded: “The FDA alert does not contain any information that would justify changes in laboratory policy for patient monitoring or treatment algorithms for hypersensitivity reactions,” but recommended asking patients if they are allergic to PEG.

“The FDA letter did not disclose a new risk, it just identified a specific type of risk that was already contemplated in product labels,” said Richard Barr, M.D., an ICUS board member, radiologist in Youngstown Ohio and CEUS expert. Dr. Barr also is editor-in-chief of the Journal of Ultrasound in Medicine. “UCA product labels have long warned against use in small numbers of patients with sensitivities to any product components,” he added.

UCAs (sometimes also known as “ultrasound enhancing agents”) are radiation-free imaging agents that enhance conventional ultrasound scans, often producing images with higher resolution than more expensive imaging options such as computed tomography (CT) or magnetic resonance imaging (MRI) — which present their own risks, according ICUS, a grassroots medical society with members in 60 countries.

In addition, a reliable CEUS scan may reduce the need for downstream tests, which in turn can lower overall imaging costs, expedite the patient’s diagnosis and treatment, and improve hospital workflows, according to the AIUM statement.

PEG is found in thousands of drugs including over the counter laxatives and bowel preps, skin creams, cosmetics and household products, according to the AIUM.

“UCAs are extremely safe and beneficial for the overwhelming number of our patients,” said Michael Main, M.D., Vice President of ICUS and co-executive medical director of Saint Luke’s Mid America Heart Institute in Kansas City. Main is the senior author of numerous UCA safety studies and co-authored the ASE statement.

“We use UCAs day in and day out to image soft tissue tumors of the abdomen and pelvis, providing a very safe, low-cost, versatile and reliable imaging option for our patients,” said Stephanie Wilson, M.D., Co-President of ICUS and expert in the use of CEUS for general imaging.

PEG is an inactive ingredient in Definity (Lantheus Medical Imaging) and Lumason (Bracco), and their product labels were recently updated to highlight PEG risk. A third UCA, Optison (GE Healthcare), does not contain PEG.

For more information: www.ICUS-SOCIETY.org

Related Content

Illustration of how spectral CT can help confirm findings on a conventional CT scan without requiring follow-up imaging, such as a nuclear scan. The conventional CT on the left, and the dual-energy CT on the right confirms an infarct.

Illustration of how spectral CT can help confirm findings on a conventional CT scan without requiring follow-up imaging, such as a nuclear scan. The conventional CT on the left, and the dual-energy CT on the right confirms an infarct. Image from Philips Healthcare.

Feature | Computed Tomography (CT) | May 27, 2021
May 27, 2021 — Philips Healthcare released a workhorse...
FDA Clears AiCE Image Reconstruction on Canon's Aquilion Precision CT
Technology | Computed Tomography (CT) | October 21, 2019
Canon Medical Systems USA Inc. has received U.S. Food and Drug Administration (FDA) 510(k) clearance on its Advanced...
FDA Clears Modules of AI-Rad Companion Chest CT From Siemens Healthineers
Technology | Computed Tomography (CT) | September 26, 2019
The U.S. Food and Drug Administration (FDA) has cleared three modules of AI-Rad Companion Chest CT, an intelligent...
Videos | Computed Tomography (CT) | August 07, 2019
This is an example of in-stent restenosis shown using spectral CT imaging.
Achenbach to Receive Inaugural 2019 Stephan Achenbach Pioneer Award in Cardiovascular CT
News | Computed Tomography (CT) | July 10, 2019
The Society of Cardiovascular Computed Tomography (SCCT) will present Stephan Achenbach, M.D., FSCCT with the inaugural...
New Type of Cardiac Care to Cut Imaging Wait Times and Unnecessary Hospital Admissions
News | Computed Tomography (CT) | June 20, 2019
A new type of care for cardiac patients at St. Paul’s Hospital, Vancouver, has the potential to reduce heart imaging...
Canon Medical Receives FDA Clearance for AiCE Reconstruction Technology for CT
Technology | Computed Tomography (CT) | June 18, 2019
Canon Medical Systems USA Inc. has received 510(k) clearance on its new deep convolutional neural network (DCNN) image...
SCCT Announces 2019 Gold Medal Award Recipients

Jonathon Leipsic, M.D., (left) and Gilbert Raff, M.D., (right)

News | Computed Tomography (CT) | June 05, 2019
The Society of Cardiovascular Computed Tomography (SCCT) will present the 2019 Gold Medal Award to Jonathon Leipsic, M....
Johns Hopkins Medicine First in U.S. to Install Canon Medical's Aquilion Precision
News | Computed Tomography (CT) | March 26, 2019
Johns Hopkins Medicine now has access to the first Ultra-High Resolution computed tomography (UHR CT) system for...