Sulfur hexafluoride lipid-type A microspheres

(Lumason®)

Lumason®

Drug updated on 9/4/2024

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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  • Lumason (sulfur hexafluoride lipid-type A microspheres) is indicated for use in echocardiography to opacify the left ventricular chamber and improve the delineation of the left ventricular endocardial border in adult and pediatric patients with suboptimal echocardiograms. It is also indicated for use in ultrasonography of the liver for the characterization of focal liver lesions in adult and pediatric patients. Additionally, Lumason is used in ultrasonography of the urinary tract for the evaluation of suspected or known vesicoureteral reflux in pediatric patients.
  • This summary is based on the review of two systematic review(s)/meta-analysis(es). [1-2]
  • For renal mass characterization in patients with complex cystic renal lesions, Lumason demonstrated a sensitivity of 95% (95% CI: 91%-99%) and a specificity of 84% (95% CI: 77%-90%); for solid renal lesions, the sensitivity was 98% (95% CI: 95%-100%) and specificity was 78% (95% CI: 68%-88%).
  • In the assessment of fallopian tubal patency in infertile females, Lumason exhibited a sensitivity of 93% (95% CI: 90%-95%), a specificity of 90% (95% CI: 87%-92%), and an area under the ROC curve of 0.96 (95% CI: 94%-98%). The four-dimensional HyCoSy subgroup displayed higher specificity compared to the 2D/3D subgroup.
  • There is no safety information available in the reviewed studies regarding the use of Lumason for renal mass characterization.
  • There is no safety information available in the reviewed studies regarding the use of sulfur hexafluoride microbubbles for fallopian tubal patency assessment.
  • Population Types and Subgroup Considerations: The evidence source indicates that for renal mass characterization, the study does not specify findings relevant to specific population types or subgroups. In the case of fallopian tubal patency assessment, infertile females were the population type studied, with subgroup analysis showing higher specificity in the four-dimensional HyCoSy subgroup compared to the 2D/3D subgroup; increasing the contrast agent dose did not significantly affect specificity but slightly reduced sensitivity.