Ultrasound Molecular Agent Gets FDA Fast Track Designation for Active Bowel Inflammation with Crohn’s Disease
Phase 2 studies of the BR55 ultrasound contrast agent reportedly demonstrated a 95 percent accuracy in showing the expression of vascular endothelial growth factor receptor 2 (VEGFR2) in bowel segments reflecting active inflammation in patients with Crohn’s disease.
The Food and Drug Administration (FDA) has granted fast track designation to BR55, an emerging molecular ultrasound contrast agent, for the diagnosis of active bowel inflammation in patients with Crohn’s disease.
Targeting the vascular endothelial growth factor receptor 2 (VEGFR2), the injection of BR55 (perfluorobutane/nitrogen lipopeptide-coated microbubbles) achieved a 95 percent accuracy in revealing active bowel inflammation in patients with Crohn’s disease in phase 2 studies, according to Bracco Imaging, the developer of the ultrasound contrast agent.
The company maintained that the use of BR55 to detect angiogenesis through non-invasive, radiation-free ultrasound imaging may enhance monitoring and facilitate timely treatment in this patient population.
“The FDA fast track process is aimed at improving the management of patients with serious conditions and filling an unmet medical need, such as the accurate monitoring of disease activity in patients with Crohn's disease,” noted Alberto Spinazzi, M.D., the chief medical and regulatory officer for the Bracco Imaging Group. “This fast track designation supports our goal to get BR55 to the patient earlier and more efficiently."
Bracco Imaging noted that the efficacy and safety of BR55 will be evaluated in forthcoming multicenter, multinational phase 3 studies.
Recent Videos
Related Content
Can Ultrasound-Based Radiomics Enhance Differentiation of HER2 Breast Cancer?
March 11th 2025Article
Multicenter research revealed that a combined model of clinical factors and ultrasound-based radiomics exhibited greater than a 23 percent higher per patient-level accuracy rate for identifying HER2 breast cancer than a clinical model.
The Reading Room: Racial and Ethnic Minorities, Cancer Screenings, and COVID-19
November 3rd 2020Podcast
In this podcast episode, Dr. Shalom Kalnicki, from Montefiore and Albert Einstein College of Medicine, discusses the disparities minority patients face with cancer screenings and what can be done to increase access during the pandemic.
Can CT-Based AI Help Predict Renal Function Decline After Radioligand Therapy for mCRPC?
February 25th 2025Article
In patients who had at least four cycles of 177Lu-PSMA-I&T for mCRPC, new research shows that a 10 percent or greater decrease in total kidney volume on CT at six months has a 90 percent AUC for predicting estimated glomerular filtration rates (eGFRs) of 30 percent or greater at one year.
Study: AI Boosts Ultrasound AUC for Predicting Thyroid Malignancy Risk by 34 Percent Over TI-RADS
February 17th 2025Article
In a study involving assessment of over 1,000 thyroid nodules, researchers found the machine learning model led to substantial increases in sensitivity and specificity for estimating the risk of thyroid malignancy over traditional TI-RADS and guidelines from the American Thyroid Association.
