FDA OKs Bracco's ultrasound enhancing agent

By AuntMinnie.com staff writers

December 4, 2019 -- Contrast developer Bracco Diagnostics announced its contrast agent Lumason is the first ultrasound enhancing agent to obtain U.S. Food and Drug Administration (FDA) clearance for use in echocardiography to opacify the left ventricular chamber. The agent also improves the delineation of the left ventricular endocardial border in pediatric patients with suboptimal echocardiograms.

Lumason is distributed globally outside the U.S. as SonoVue and has been marketed since 2001 for use in adult populations.

In other Bracco news, an experimental artificial intelligence study of two gadolinium-based contrast agents found that ProHance (gadoteridol) at 279.3 mg/mL and Gadavist provided a similar degree and pattern of contrast enhancement in brain MR images. The study specifically looked at patients with glioblastoma multiforme previously enrolled in a large-scale, multicenter, randomized, double-blinded controlled clinical study (TRUTH study).

Each of the 32 patients with glioblastoma multiforme received both ProHance contrast and Gadavist contrast in a double-blind, randomized crossover method. The images were evaluated in a blinded fashion using a layered machine-learning system. Enhancement characteristics for both agents were processed and the differences for each set of image pairs were calculated and analyzed.

In the 27 evaluable patients, the machine-learning system found no statistically significant difference in enhancement characteristics between the standard concentration of ProHance contrast and the double concentration of Gadavist contrast.

Full study results will be presented at RSNA 2019 in Chicago.

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