Contrast Enhanced 3D Echocardiographic Quantification of Right Ventricular Volumes in Repaired CHD

NCT05186415 | Completed Phase 1 Results DMC FDA Drug

• 1 other identifier: 1764041-1
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Tetralogy of Fallot; Pulmonary Insufficiency

Keywords

ultrasound enhancing agent; echocardiography; lumason

Outcome Measures

Primary Outcomes (3)

• Accuracy of 3D Echocardiography Based Measurements of Right Ventricular Size Compared to MRI Derived Values.

  Echocardiography derived measurements of right ventricular end-diastolic volume, end-systolic volume, with and without contrast, and MRI derived values in patients with repaired congenital heart disease

  All images were obtained on the same day of the study. MRI analysis performed by clinical reading attending. Echo analysis performed offline after completing of imaging.

• Accuracy of 3D Echocardiography Based Measurements of Right Ventricular Function Compared to MRI Derived Values.

  Echocardiography derived measurements of right ventricular ejection fraction, with and without contrast, and MRI derived values in patients with repaired congenital heart disease

  All images were obtained on the same day of the study. MRI analysis performed by clinical reading attending. Echo analysis performed offline after completing of imaging.

• Inter-rater Reliability of 3D Echocardiography Based Measurements of Right Ventricular Size and Function With and Without Contrast

  The agreement of echocardiography derived measurements of right ventricular end-diastolic volume, end-systolic volume, and ejection fraction, with and without contrast, will be compared between the two readers using the intraclass correlation coefficient.

  All echocardiographic images obtained on the day of the study participation. Analysis done offline.

Secondary Outcomes (1)

• Comparing Echocardiographic and MRI Derived Right Ventricular Strain Measurement.

  Echocardiography and MRI images obtained on the day of study participation. Analysis done after image acquisition complete

Study Arms (1)

diagnostic arm

EXPERIMENTAL

Contrast enhanced 3D echo (Lumason)

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

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.

diagnostic arm

Eligibility Criteria

• Age: 11 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Informed written consent of parent or legal guardian.
• Informed written assent of subject, if appropriate.

You may not qualify if:

• Any patients in which Lumason is contraindicated (i.e. prior anaphylactoid reaction) will be ineligible for the clinical ultrasound and ineligible for the study.
• History of allergic reaction to Lumason, sulfur hexafluoride, sulfur hexafluoride lipid microsphere components, or other ingredients in Lumason (polyethylene glycol, distearoylphosphatidylcholine (DSPC), dipalmitoylphosphatidylglycerol sodium (DPPG-Na), palmitic acid)
• Pregnant women will be excluded from the study as well since Lumason has not been studied in pregnancy.

Sponsors & Collaborators

• Nemours Children's Clinic: lead
• Thomas Jefferson University: collaborator

Study Sites (1)

Nemours Childrens Hospital

Wilmington, Delaware, 19803, United States

Location

Related Publications (21)

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MeSH Terms

Conditions

Tetralogy of Fallot; Respiratory Insufficiency

Interventions

Suspensions

Condition Hierarchy (Ancestors)

Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Respiration Disorders; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations

Limitations and Caveats

We acknowledge several limitations in our single-center study including the small sample size. Many patients had poor or suboptimal image quality which likely contributes to inaccuracies in calculation of RV size by echocardiography. The software used to analyze the RD echocardiography images was not designed for use with contrast enhanced echocardiograms potentially limiting the accuracy.

Results Point of Contact

• Title: Shannon Nees, MD
• Organization: Nemours Children's Hospital, Delaware

shannon.nees@nemours.org

302-651-6600

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pediatric Cardiologist

Study Record Dates

• First Submitted: December 20, 2021
• First Posted: January 11, 2022
• Study Start: August 23, 2022
• Primary Completion: June 25, 2024
• Study Completion: June 25, 2024
• Last Updated: April 27, 2026
• Results First Posted: November 28, 2025

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)