CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 25 enrolled
Drug / intervention
Sulfur Hexafluoride Lipid Type A Microspheres 25 MG Injection Powder for Suspension [LUMASON]drug
Likely dose
Sulfur Hexafluoride Lipid Type A Microspheres 25 MG Injection Powder for Suspension [LUMASON]from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05186415
NCT05186415Phase 2Completed
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Contrast Enhanced Three Dimensional Echocardiographic Quantification of Right Ventricular Volumes in Repaired Congenital Heart Disease

Nemours Children's Clinic·interventional·Posted Jan 11, 2022·Updated Apr 27, 2026

In Brief

A Phase 2 clinical trial evaluating Sulfur Hexafluoride Lipid Type A Microspheres 25 MG Injection Powder for Suspension [LUMASON] for Tetralogy of Fallot and Pulmonary Insufficiency. Completed, enrolled 25 participants across 1 site.

Detailed Summary

We propose the novel integration of two echocardiographic technologies - three-dimensional echocardiography using semi-automated right ventricular analysis coupled with the administration of ultrasound enhancing agents - to improve the inter-rater reliability and accuracy of various measures of right ventricular size and function, compared with cardiac MRI.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTetralogy of Fallot, Pulmonary Insufficiency
CountriesUnited States
CollaboratorsThomas Jefferson University

Timeline

Phase 2CompletedFinished
20222023202420252026
First PostedJan 11, 2022
Enrollment StartAug 23, 2022
Primary CompletionJun 25, 2024
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 4.5 years ago

Interventions

Sulfur Hexafluoride Lipid Type A Microspheres 25 MG Injection Powder for Suspension [LUMASON]drug

The patient will receive the weight-based dose of Lumason of 0.03 mL/kg per injection, not to exceed 2.4 mL per injection per the FDA and manufacturer recommendations.