We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies. Cookie Policy.

Features Partner Sites Information LinkXpress
Sign In
Advertise with Us

Download Mobile App

Diagnostic Ultrasound Enhancing Agent to Improve Image Quality in Pediatric Heart Patients

By MedImaging International staff writers
Posted on 25 Mar 2024
Print article
Image: The DEFINITY ultrasound enhancing agent has received FDA approval for pediatric patients (Photo courtesy of Lantheus)
Image: The DEFINITY ultrasound enhancing agent has received FDA approval for pediatric patients (Photo courtesy of Lantheus)

Despite advancements in echocardiography, imaging can be suboptimal, which may lead to inadequate treatment plans, unnecessary additional testing, increased hospital stays and avoidable hospital readmissions. Now, the most utilized, extensively studied, and trusted diagnostic ultrasound enhancing agent in the U.S. can now also address the unmet medical needs of pediatric patients.

Lantheus Holdings (Bedford, MA, USA) has received the U.S. Food and Drug Administration (FDA) approval for its supplemental new drug application (sNDA) for DEFINITY (Perflutren Lipid Microsphere) as an ultrasound enhancing agent for use in pediatric patients with suboptimal echocardiograms. This approval provides healthcare professionals with a valuable tool to opacify the left ventricular chamber and better identify the left ventricular endocardial border, marking a significant step forward in pediatric medicine. The FDA decision was based on usage data from three pediatric clinical trials involving DEFINITY: the Golding study, which assessed 40 patients aged between 1 month and 17 years with significant heart conditions, such as heart transplants, Kawasaki disease, or congenital cardiovascular anomalies; the Fine study, which looked at 36 individuals aged between 10 to 21 years who had previously had a heart transplant; and the Kutty study, which was a retrospective review of medical records for 113 pediatric patients aged 5 to 21 years diagnosed with or suspected of having congenital or acquired heart disease. A total of 189 patients were evaluated in these studies, with 107 (56.5%) being male and 82 (43.5%) female.

The data from the Golding study, along with additional insights from the Fine and Kutty studies, show that DEFINITY can successfully enhance the left ventricular opacification in children at cumulative doses ranging from 6 µL/kg to 20 µL/kg, and that ultrasound contrast is vital for managing such patients. In the Golding study, enhancements were seen in detecting wall motion abnormalities and in performing ejection fraction determinations for the majority of subjects (70% and 80%, respectively). The Kutty and Fine studies both reported successful enhancement of the left ventricular chamber in all participants. Specifically, the Kutty study found wall motion or myocardial perfusion abnormalities in 13 (11.5%) patients, all identified during stress tests, and an increase in the average number of left ventricular segments visualized from 13 ± 1 per patient to 16 ± 1 segments per patient with the contrast. Meanwhile, the Fine study noted regional wall motion abnormalities in three patients (8.3%) and achieved successful myocardial perfusion imaging in 32 patients (88.9%), although some imaging results were affected by movement and/or inadequate heart rate.

“The expanded indication for DEFINITY is a testament to the rigorous research and development efforts undertaken by Lantheus to address unmet medical needs of pediatric patients,” said Jean-Claude Provost, MD, Chief Medical Officer. “We are proud that this approval will extend the benefits of DEFINITY to healthcare professionals who work with these young individuals.”

Gold Member
Solid State Kv/Dose Multi-Sensor
Ultrasound System
P20 Elite
Brachytherapy Planning System
Oncentra Brachy
Ultrasound Table
Ergonomic Advantage (EA) Line

Print article



view channel
Image: The emerging role of MRI alongside PSA testing is redefining prostate cancer diagnostics (Photo courtesy of 123RF)

Combining MRI with PSA Testing Improves Clinical Outcomes for Prostate Cancer Patients

Prostate cancer is a leading health concern globally, consistently being one of the most common types of cancer among men and a major cause of cancer-related deaths. In the United States, it is the most... Read more

Nuclear Medicine

view channel
Image: The new SPECT/CT technique demonstrated impressive biomarker identification (Journal of Nuclear Medicine: doi.org/10.2967/jnumed.123.267189)

New SPECT/CT Technique Could Change Imaging Practices and Increase Patient Access

The development of lead-212 (212Pb)-PSMA–based targeted alpha therapy (TAT) is garnering significant interest in treating patients with metastatic castration-resistant prostate cancer. The imaging of 212Pb,... Read more

General/Advanced Imaging

view channel
Image: The Tyche machine-learning model could help capture crucial information. (Photo courtesy of 123RF)

New AI Method Captures Uncertainty in Medical Images

In the field of biomedicine, segmentation is the process of annotating pixels from an important structure in medical images, such as organs or cells. Artificial Intelligence (AI) models are utilized to... Read more

Imaging IT

view channel
Image: The new Medical Imaging Suite makes healthcare imaging data more accessible, interoperable and useful (Photo courtesy of Google Cloud)

New Google Cloud Medical Imaging Suite Makes Imaging Healthcare Data More Accessible

Medical imaging is a critical tool used to diagnose patients, and there are billions of medical images scanned globally each year. Imaging data accounts for about 90% of all healthcare data1 and, until... Read more
Copyright © 2000-2024 Globetech Media. All rights reserved.