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.
![Examples of ultrasound findings and techniques. (A) Images in a 39-year-old male patient with a mass in the left thigh. The mass is heterogeneous on the B-mode US image (compared with the patient in D) and showed increased microvascularity (superb microvascular imaging [SMI]) and shear-wave elastography (SWE) values. Undifferentiated pleomorphic sarcoma was diagnosed at biopsy (with pleomorphic rhabdomyosarcoma in surgical specimen). (B) Images in an 18-year-old male patient with a mass in the left leg. The mass is hypoechoic on the B-mode image, with no other findings suggestive of malignancy. The lesion is in contact with the cortex of the tibia, which is slightly irregular. CT revealed a doubtful anteromedial tibial erosion. The microvascular study demonstrated high vascularization, suggestive of malignancy. Periosteal Ewing sarcoma was diagnosed with both histologic and immunohistochemical confirmation. (C) Images in a 69-year-old female patient with a lump growing on the outside of the left leg. Multiple SWE examinations were performed (please note the high values obtained in the measurements, whereas the color map highlights the stiffness relative to adjacent tissues). SMI showed areas of increased vascularization to target for sampling. Undifferentiated spindle cell sarcoma was diagnosed at biopsy, with residual leiomyosarcoma in the surgical specimen after neoadjuvant therapy. (D) Images in a 56-year-old female patient with a mass in the right thigh. The mass is heterogeneous at both B-mode ultrasound (similar to patient A) and MRI (coronal T2-weighted spectral attenuated inversion recovery [SPAIR]; T1-weighted pre-contrast and postcontrast imaging), which even shows uptake after the administration of paramagnetic contrast material, which is traditionally suggestive of malignancy. Low values at SMI and elastography are suggestive of benignity. Spindle cell lipoma was diagnosed at biopsy, with atypical spindle cell lipomatous tumor in the surgical specimen.](https://img.auntminnie.com/mindful/smg/workspaces/default/uploads/2026/08/images-radiol250278fig2.APCFLSvX6p.jpg?auto=format%2Ccompress&dpr=2&fit=crop&h=167&q=70&w=250)
