The U.S. Food and Drug Administration (FDA) has approved a pediatric indication for GE HealthCare’s (GEHC’s) Optison ultrasound enhancing agent.
Optison (Perflutren Protein-Type A Microspheres Injectable Suspension, USP) contains gas-filled microbubbles that reflect ultrasound waves more effectively than surrounding tissues or blood to improve visibility of the heart chambers and endocardial borders for assessing and diagnosing heart conditions. Optison does not contain polyethylene glycol (PEG), which allows it to be safely used by patients with PEG hypersensitivity, GEHC said.
Optison, which was approved by the FDA for adult use in 1997, is currently indicated for patients with suboptimal echocardiograms.
In a statement, GEHC noted that the FDA approval for Optison’s pediatric use follows GEHC’s Phase IV, prospective open-label multicenter study to evaluate the efficacy of Optison for contrast-enhanced echocardiograms. The study found that the use of intravenous Optison improved endocardial border delineation, visualization of left ventricular wall segments, and reduced the number of suboptimal echocardiogram images in pediatric patients.
![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)
