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Sulfur hexafluoride lipid-type A microspheres

(Lumason®)

Lumason®

Drug updated on 12/11/2024

Dosage FormInjection (intravenous: Lipid-type A/ sulfur hexafluoride [25 mg/60.7 mg])
Drug ClassUltrasound contrast agents
Ongoing and
Completed Studies		ClinicalTrials.gov

Indication

  • Indicated for use in echocardiography to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border in adult and pediatric patients with suboptimal echocardiograms
  • Indicated for use in ultrasonography of the liver for characterization of focal liver lesions in adult and pediatric patients
  • Indicated for use ultrasonography of the urinary tract for the evaluation of suspected or known vesicoureteral reflux in pediatric patients.

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Summary
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  • This summary is based on the review of two systematic review(s)/meta-analysis(es). [1-2]
  • Hysterosalpingo-contrast sonography (HyCoSy) using sulfur hexafluoride microbubbles demonstrated high diagnostic accuracy for fallopian tubal patency assessment with a sensitivity of 93% (95% confidence interval (CI): 90-95%) and specificity of 90% (95% CI: 87-92%). Four-dimensional (4D) HyCoSy had higher specificity than 2D/3D, and an increased contrast agent dose slightly reduced sensitivity without affecting specificity.
  • Silicone oil versus SF₆ gas for retinal detachment associated with proliferative vitreoretinopathy (PVR) showed no significant differences in visual acuity at two years; however, silicone oil provided better macular attachment outcomes at one year and two years (58% vs. 79%; relative risk (RR) 1.37; 95% CI 1.01-1.86; low-certainty evidence). In retinal detachment associated with PVR, there were no significant differences in adverse events between standard silicone oil (1000 centistoke) and heavy silicone oil (5000 centistoke) for outcomes like intraocular pressure elevation at 18 months (24% vs. 22%; RR 0.90; 95% CI 0.41-1.94), visually significant cataract formation (49% vs. 64%; RR 1.30; 95% CI 0.89-1.89), and retinal detachment following silicone oil removal (RR 0.36; 95% CI 0.08-1.67).
  • Silicone oil and heavy silicone oil also showed no significant difference in rates of retinal detachment at one year (25% vs. 22%; RR 0.89; 95% CI 0.54-1.48), suggesting similar safety profiles in managing PVR-related retinal detachment. HyCoSy using sulfur hexafluoride microbubbles found that 4D HyCoSy provided higher specificity than 2D/3D, and increased contrast agent doses slightly reduced sensitivity without impacting specificity. For retinal detachment associated with PVR, the population consisted predominantly of males aged 21 to 89 years, with no significant subgroup differences in adverse events between standard and heavy silicone oil.