Tetralogy of FallotPhase 1/2NCT05186415
Contrast Enhanced 3D Echocardiographic Quantification of Right Ventricular Volumes in Repaired CHD
A Phase 1/2 study testing Sulfur Hexafluoride Lipid Type A Microspheres 25 MG Injection Powder for Suspension [LUMASON] in people with Tetralogy of Fallot and Pulmonary Insufficiency, run by Nemours Children's Clinic at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 11 years and older
- Conditions the study is for
- Tetralogy of Fallot, Pulmonary Insufficiency
- What is being tested?
- Sulfur Hexafluoride Lipid Type A Microspheres 25 MG Injection Powder for Suspension [LUMASON]
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Aug 2022to 25 Jun 2024
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All patients aged 11 or greater with repaired congenital heart disease and residual pulmonary insufficiency who are referred to Nemours A.I. DuPont Hospital for Children for clinically indicated cardiac MRI will be eligible for inclusion.
- Informed written consent of parent or legal guardian.
- Informed written assent of subject, if appropriate.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Nemours Childrens Hospital
Wilmington, Delaware, 19803
About this study
Official title: Contrast Enhanced Three Dimensional Echocardiographic Quantification of Right Ventricular Volumes in Repaired Congenital Heart Disease
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.
Read the detailed description
Patients with repaired congenital heart disease with residual pulmonary insufficiency represent a challenging group of patients with congenital heart disease as they develop progressive right ventricular dilation and failure, increasing the risk for sudden cardiac death and often necessitating pulmonary valve replacement. These patients require close follow-up with serial cardiac imaging; however, the complex three-dimensional structure of these dilated right ventricles renders them difficult to adequately image with traditional two-dimensional echocardiography. Due to these difficulties, cardiac MRI is the current gold standard for assessing right ventricular size and function in these patients. However, cardiac MRI is costly and less accessible for patients than echocardiography. Although initial studies comparing 3D echocardiography with MRI showed that 3D echocardiography underestimates right ventricular size, recent advances in three-dimensional imaging technologies which utilize automated ultrasound "speckle-tracking" and artificial intelligence technology are lessening this inherent bias. Furthermore, the use of commercially-available ultrasound enhancing agents made of lipid microspheres has improved left ventricular endocardial border detection, inter-rater reliability and correlation of 3D echocardiography obtained estimates of left ventricular size and function compared with Cardiac Magnetic Resonance (CMR). However, their use has yet to be applied to the three-dimensional echocardiographic assessment of the right ventricle in congenital heart disease despite their ability to improve right ventricular endocardial border detection with three-dimensional echocardiography in adults. The investigators 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 change the paradigm of how clinicians assess the right ventricles of patients with repaired congenital heart disease with residual pulmonary insufficiency. The investigators hypothesize that ultrasound enhancing agents will improve the inter-rater reliability and accuracy of various measures of right ventricular size and function, compared with cardiac MRI, thereby filling an important gap in existing methods for assessing right ventricular function. Lastly, because of the current limitations in assessing right ventricular function in this population, as a secondary aim, the investigators will also assess three-dimensional right ventricular strain -- a novel quantitative surrogate of right ventricular function.
Overall Objectives: To shift the paradigm in the assessment of right ventricular size and function by developing a protocol to assess the right ventricles in patients with repaired congenital heart disease with residual pulmonary insufficiency by integrating the use of three-dimensional echocardiography with semi-automated right ventricular analysis software with the intravenous administration of ultrasound enhancing agents.
Specific Aim 1. To compare the accuracy and inter-rater reliability of 3D echocardiography-based measurements of right ventricular end-diastolic volume, end-systolic volume, and ejection fraction, with and without contrast, with MRI derived values in patients with repaired congenital heart disease with residual pulmonary insufficiency.
Specific Aim 2. To compare the accuracy and inter-rater reliability of 3D echocardiography measurement of right ventricular strain with MRI derived right ventricular (RV) strain in patients with repaired congenital heart disease with residual pulmonary insufficiency.
- Conditions
- Tetralogy of Fallot, Pulmonary Insufficiency
- Being tested
- Sulfur Hexafluoride Lipid Type A Microspheres 25 MG Injection Powder for Suspension [LUMASON]
- Keywords
- ultrasound enhancing agent, echocardiography, lumason
- Medical subject headings
- Tetralogy of Fallot, Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| diagnostic arm | Experimental | Contrast enhanced 3D echo (Lumason) Receives: Drug: Sulfur Hexafluoride Lipid Type A Microspheres 25 MG Injection Powder for Suspension [LUMASON] |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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.
Measured: 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.
3D echocardiography measurement of right ventricular strain will be compared with MRI derived RV strain in patients with repaired congenital heart disease using an intraclass correlation coefficient.
Measured: Echocardiography and MRI images obtained on the day of study participation. Analysis done after image acquisition complete
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2022
- Study start23 Aug 2022
- Primary completion25 Jun 2024
- Study completion25 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Tetralogy of FallotStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nemours Children's Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Thomas Jefferson University
- Responsible party
- Principal investigator, Shannon N. Nees, MD, Nemours Children's Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05186415
- Sponsor's protocol ID
- 1764041-1
- Status last verified
- Apr 2026
- First submitted
- 20 Dec 2021
- Last updated
- 27 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Weinberg CR, McElhinney DB. Pulmonary valve replacement in tetralogy of Fallot. Circulation. 2014 Aug 26;130(9):795-8. doi: 10.1161/CIRCULATIONAHA.114.005551. No abstract available.
PubMed 25156915Geva T. Repaired tetralogy of Fallot: the roles of cardiovascular magnetic resonance in evaluating pathophysiology and for pulmonary valve replacement decision support. J Cardiovasc Magn Reson. 2011 Jan 20;13(1):9. doi: 10.1186/1532-429X-13-9.
PubMed 21251297Valente AM, Cook S, Festa P, Ko HH, Krishnamurthy R, Taylor AM, Warnes CA, Kreutzer J, Geva T. Multimodality imaging guidelines for patients with repaired tetralogy of fallot: a report from the AmericanSsociety of Echocardiography: developed in collaboration with the Society for Cardiovascular Magnetic Resonance and the Society for Pediatric Radiology. J Am Soc Echocardiogr. 2014 Feb;27(2):111-41. doi: 10.1016/j.echo.2013.11.009. No abstract available.
PubMed 24468055Shimada YJ, Shiota M, Siegel RJ, Shiota T. Accuracy of right ventricular volumes and function determined by three-dimensional echocardiography in comparison with magnetic resonance imaging: a meta-analysis study. J Am Soc Echocardiogr. 2010 Sep;23(9):943-53. doi: 10.1016/j.echo.2010.06.029.
PubMed 20797527Muraru D, Spadotto V, Cecchetto A, Romeo G, Aruta P, Ermacora D, Jenei C, Cucchini U, Iliceto S, Badano LP. New speckle-tracking algorithm for right ventricular volume analysis from three-dimensional echocardiographic data sets: validation with cardiac magnetic resonance and comparison with the previous analysis tool. Eur Heart J Cardiovasc Imaging. 2016 Nov;17(11):1279-1289. doi: 10.1093/ehjci/jev309. Epub 2015 Dec 8.
PubMed 26647080Laser KT, Karabiyik A, Korperich H, Horst JP, Barth P, Kececioglu D, Burchert W, DallaPozza R, Herberg U. Validation and Reference Values for Three-Dimensional Echocardiographic Right Ventricular Volumetry in Children: A Multicenter Study. J Am Soc Echocardiogr. 2018 Sep;31(9):1050-1063. doi: 10.1016/j.echo.2018.03.010. Epub 2018 Jun 19.
PubMed 29908725Medvedofsky D, Addetia K, Patel AR, Sedlmeier A, Baumann R, Mor-Avi V, Lang RM. Novel Approach to Three-Dimensional Echocardiographic Quantification of Right Ventricular Volumes and Function from Focused Views. J Am Soc Echocardiogr. 2015 Oct;28(10):1222-31. doi: 10.1016/j.echo.2015.06.013. Epub 2015 Aug 1.
PubMed 26237996Jenner J, Sorensson P, Pernow J, Caidahl K, Eriksson MJ. Contrast Enhancement and Image Quality Influence Two- and Three-dimensional Echocardiographic Determination of Left Ventricular Volumes: Comparison With Magnetic Resonance Imaging. Clin Med Insights Cardiol. 2019 Mar 5;13:1179546819831980. doi: 10.1177/1179546819831980. eCollection 2019.
PubMed 30858745van den Bosch AE, Meijboom FJ, McGhie JS, Roos-Hesselink JW, Ten Cate FJ, Roelandt JR. Enhanced visualisation of the right ventricle by contrast echocardiography in congenital heart disease. Eur J Echocardiogr. 2004 Mar;5(2):104-10. doi: 10.1016/S1525-2167(03)00048-9.
PubMed 15036021Mueller M, Rentzsch A, Hoetzer K, Raedle-Hurst T, Boettler P, Stiller B, Lemmer J, Sarikouch S, Beerbaum P, Peters B, Vogt M, Vogel M, Abdul-Khaliq H. Assessment of interventricular and right-intraventricular dyssynchrony in patients with surgically repaired tetralogy of Fallot by two-dimensional speckle tracking. Eur J Echocardiogr. 2010 Oct;11(9):786-92. doi: 10.1093/ejechocard/jeq067. Epub 2010 May 30.
PubMed 20513701Friedberg MK, Fernandes FP, Roche SL, Slorach C, Grosse-Wortmann L, Manlhiot C, Fackoury C, McCrindle BW, Mertens L, Kantor PF. Relation of right ventricular mechanics to exercise tolerance in children after tetralogy of Fallot repair. Am Heart J. 2013 Apr;165(4):551-7. doi: 10.1016/j.ahj.2012.06.029. Epub 2013 Mar 5.
PubMed 23537972Hoffman JI, Kaplan S. The incidence of congenital heart disease. J Am Coll Cardiol. 2002 Jun 19;39(12):1890-900. doi: 10.1016/s0735-1097(02)01886-7.
PubMed 12084585Stout KK, Daniels CJ, Aboulhosn JA, Bozkurt B, Broberg CS, Colman JM, Crumb SR, Dearani JA, Fuller S, Gurvitz M, Khairy P, Landzberg MJ, Saidi A, Valente AM, Van Hare GF. 2018 AHA/ACC Guideline for the Management of Adults With Congenital Heart Disease: Executive Summary: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. J Am Coll Cardiol. 2019 Apr 2;73(12):1494-1563. doi: 10.1016/j.jacc.2018.08.1028. Epub 2018 Aug 16. No abstract available.
PubMed 30121240Heng EL, Gatzoulis MA, Uebing A, Sethia B, Uemura H, Smith GC, Diller GP, McCarthy KP, Ho SY, Li W, Wright P, Spadotto V, Kilner PJ, Oldershaw P, Pennell DJ, Shore DF, Babu-Narayan SV. Immediate and Midterm Cardiac Remodeling After Surgical Pulmonary Valve Replacement in Adults With Repaired Tetralogy of Fallot: A Prospective Cardiovascular Magnetic Resonance and Clinical Study. Circulation. 2017 Oct 31;136(18):1703-1713. doi: 10.1161/CIRCULATIONAHA.117.027402.
PubMed 29084778Oosterhof T, van Straten A, Vliegen HW, Meijboom FJ, van Dijk AP, Spijkerboer AM, Bouma BJ, Zwinderman AH, Hazekamp MG, de Roos A, Mulder BJ. Preoperative thresholds for pulmonary valve replacement in patients with corrected tetralogy of Fallot using cardiovascular magnetic resonance. Circulation. 2007 Jul 31;116(5):545-51. doi: 10.1161/CIRCULATIONAHA.106.659664. Epub 2007 Jul 9.
PubMed 17620511
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contrast Enhanced Three Dimensional Echocardiographic Quantification of Right Ventricular Volumes in Repaired Congenital Heart Disease
- ClinicalTrials.gov ID
- NCT05186415
- Acronym / sponsor ID
- 1764041-1
- Conditions
- Tetralogy of Fallot, Pulmonary Insufficiency
- Keywords
- ultrasound enhancing agent, echocardiography, lumason
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Nemours Children's ClinicUniversity, hospital or other
- Collaborators
- Thomas Jefferson University
- Study start
- 23 Aug 2022 (actual)
- Primary completion
- 25 Jun 2024 (actual)
- Study completion
- 25 Jun 2024 (actual)
- First posted
- 11 Jan 2022 (actual)
- Results
- Posted 28 Nov 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Patients with repaired congenital heart disease with residual pulmonary insufficiency represent a challenging group of patients with congenital heart disease as they develop progressive right ventricular dilation and failure, increasing the risk for sudden cardiac death and often necessitating pulmonary valve replacement. These patients require close follow-up with serial cardiac imaging; however, the complex three-dimensional structure of these dilated right ventricles renders them difficult to adequately image with traditional two-dimensional echocardiography. Due to these difficulties, cardiac MRI is the current gold standard for assessing right ventricular size and function in these patients. However, cardiac MRI is costly and less accessible for patients than echocardiography. Although initial studies comparing 3D echocardiography with MRI showed that 3D echocardiography underestimates right ventricular size, recent advances in three-dimensional imaging technologies which utilize automated ultrasound "speckle-tracking" and artificial intelligence technology are lessening this inherent bias. Furthermore, the use of commercially-available ultrasound enhancing agents made of lipid microspheres has improved left ventricular endocardial border detection, inter-rater reliability and correlation of 3D echocardiography obtained estimates of left ventricular size and function compared with Cardiac Magnetic Resonance (CMR). However, their use has yet to be applied to the three-dimensional echocardiographic assessment of the right ventricle in congenital heart disease despite their ability to improve right ventricular endocardial border detection with three-dimensional echocardiography in adults. The investigators 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 change the paradigm of how clinicians assess the right ventricles of patients with repaired congenital heart disease with residual pulmonary insufficiency. The investigators hypothesize that ultrasound enhancing agents will improve the inter-rater reliability and accuracy of various measures of right ventricular size and function, compared with cardiac MRI, thereby filling an important gap in existing methods for assessing right ventricular function. Lastly, because of the current limitations in assessing right ventricular function in this population, as a secondary aim, the investigators will also assess three-dimensional right ventricular strain -- a novel quantitative surrogate of right ventricular function.
Overall Objectives: To shift the paradigm in the assessment of right ventricular size and function by developing a protocol to assess the right ventricles in patients with repaired congenital heart disease with residual pulmonary insufficiency by integrating the use of three-dimensional echocardiography with semi-automated right ventricular analysis software with the intravenous administration of ultrasound enhancing agents.
Specific Aim 1. To compare the accuracy and inter-rater reliability of 3D echocardiography-based measurements of right ventricular end-diastolic volume, end-systolic volume, and ejection fraction, with and without contrast, with MRI derived values in patients with repaired congenital heart disease with residual pulmonary insufficiency.
Specific Aim 2. To compare the accuracy and inter-rater reliability of 3D echocardiography measurement of right ventricular strain with MRI derived right ventricular (RV) strain in patients with repaired congenital heart disease with residual pulmonary insufficiency.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| diagnostic arm | Experimental | Drug: Sulfur Hexafluoride Lipid Type A Microspheres 25 MG Injection Powder for Suspension [LUMASON]Contrast enhanced 3D echo (Lumason) |
Who may qualify
- Ages
- 11 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- All patients aged 11 or greater with repaired congenital heart disease and residual pulmonary insufficiency who are referred to Nemours A.I. DuPont Hospital for Children for clinically indicated cardiac MRI will be eligible for inclusion.
- Informed written consent of parent or legal guardian.
- Informed written assent of subject, if appropriate.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sulfur Hexafluoride Lipid Type A Microspheres 25 MG Injection Powder for Suspension [LUMASON]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. | Drug | diagnostic arm |
Primary outcome
Accuracy of 3D Echocardiography Based Measurements of Right Ventricular Size Compared to MRI Derived Values.
Time frame: 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.
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
Accuracy of 3D Echocardiography Based Measurements of Right Ventricular Function Compared to MRI Derived Values.
Time frame: 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.
Echocardiography derived measurements of right ventricular ejection fraction, with and without contrast, and MRI derived values in patients with repaired congenital heart disease
Inter-rater Reliability of 3D Echocardiography Based Measurements of Right Ventricular Size and Function With and Without Contrast
Time frame: All echocardiographic images obtained on the day of the study participation. Analysis done offline.
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.
1 secondary outcome
Comparing Echocardiographic and MRI Derived Right Ventricular Strain Measurement.
Time frame: Echocardiography and MRI images obtained on the day of study participation. Analysis done after image acquisition complete
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 25156915Weinberg CR, McElhinney DB. Pulmonary valve replacement in tetralogy of Fallot. Circulation. 2014 Aug 26;130(9):795-8. doi: 10.1161/CIRCULATIONAHA.114.005551. No abstract available.
- Background: PubMed 21251297Geva T. Repaired tetralogy of Fallot: the roles of cardiovascular magnetic resonance in evaluating pathophysiology and for pulmonary valve replacement decision support. J Cardiovasc Magn Reson. 2011 Jan 20;13(1):9. doi: 10.1186/1532-429X-13-9.
- Background: PubMed 24468055Valente AM, Cook S, Festa P, Ko HH, Krishnamurthy R, Taylor AM, Warnes CA, Kreutzer J, Geva T. Multimodality imaging guidelines for patients with repaired tetralogy of fallot: a report from the AmericanSsociety of Echocardiography: developed in collaboration with the Society for Cardiovascular Magnetic Resonance and the Society for Pediatric Radiology. J Am Soc Echocardiogr. 2014 Feb;27(2):111-41. doi: 10.1016/j.echo.2013.11.009. No abstract available.
- Background: PubMed 20797527Shimada YJ, Shiota M, Siegel RJ, Shiota T. Accuracy of right ventricular volumes and function determined by three-dimensional echocardiography in comparison with magnetic resonance imaging: a meta-analysis study. J Am Soc Echocardiogr. 2010 Sep;23(9):943-53. doi: 10.1016/j.echo.2010.06.029.
- Background: PubMed 26647080Muraru D, Spadotto V, Cecchetto A, Romeo G, Aruta P, Ermacora D, Jenei C, Cucchini U, Iliceto S, Badano LP. New speckle-tracking algorithm for right ventricular volume analysis from three-dimensional echocardiographic data sets: validation with cardiac magnetic resonance and comparison with the previous analysis tool. Eur Heart J Cardiovasc Imaging. 2016 Nov;17(11):1279-1289. doi: 10.1093/ehjci/jev309. Epub 2015 Dec 8.
- Background: PubMed 29908725Laser KT, Karabiyik A, Korperich H, Horst JP, Barth P, Kececioglu D, Burchert W, DallaPozza R, Herberg U. Validation and Reference Values for Three-Dimensional Echocardiographic Right Ventricular Volumetry in Children: A Multicenter Study. J Am Soc Echocardiogr. 2018 Sep;31(9):1050-1063. doi: 10.1016/j.echo.2018.03.010. Epub 2018 Jun 19.
- Background: PubMed 26237996Medvedofsky D, Addetia K, Patel AR, Sedlmeier A, Baumann R, Mor-Avi V, Lang RM. Novel Approach to Three-Dimensional Echocardiographic Quantification of Right Ventricular Volumes and Function from Focused Views. J Am Soc Echocardiogr. 2015 Oct;28(10):1222-31. doi: 10.1016/j.echo.2015.06.013. Epub 2015 Aug 1.
- Background: PubMed 30858745Jenner J, Sorensson P, Pernow J, Caidahl K, Eriksson MJ. Contrast Enhancement and Image Quality Influence Two- and Three-dimensional Echocardiographic Determination of Left Ventricular Volumes: Comparison With Magnetic Resonance Imaging. Clin Med Insights Cardiol. 2019 Mar 5;13:1179546819831980. doi: 10.1177/1179546819831980. eCollection 2019.
- Background: PubMed 15036021van den Bosch AE, Meijboom FJ, McGhie JS, Roos-Hesselink JW, Ten Cate FJ, Roelandt JR. Enhanced visualisation of the right ventricle by contrast echocardiography in congenital heart disease. Eur J Echocardiogr. 2004 Mar;5(2):104-10. doi: 10.1016/S1525-2167(03)00048-9.
- Background: PubMed 20513701Mueller M, Rentzsch A, Hoetzer K, Raedle-Hurst T, Boettler P, Stiller B, Lemmer J, Sarikouch S, Beerbaum P, Peters B, Vogt M, Vogel M, Abdul-Khaliq H. Assessment of interventricular and right-intraventricular dyssynchrony in patients with surgically repaired tetralogy of Fallot by two-dimensional speckle tracking. Eur J Echocardiogr. 2010 Oct;11(9):786-92. doi: 10.1093/ejechocard/jeq067. Epub 2010 May 30.
- Background: PubMed 23537972Friedberg MK, Fernandes FP, Roche SL, Slorach C, Grosse-Wortmann L, Manlhiot C, Fackoury C, McCrindle BW, Mertens L, Kantor PF. Relation of right ventricular mechanics to exercise tolerance in children after tetralogy of Fallot repair. Am Heart J. 2013 Apr;165(4):551-7. doi: 10.1016/j.ahj.2012.06.029. Epub 2013 Mar 5.
- Background: PubMed 12084585Hoffman JI, Kaplan S. The incidence of congenital heart disease. J Am Coll Cardiol. 2002 Jun 19;39(12):1890-900. doi: 10.1016/s0735-1097(02)01886-7.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Sulfur Hexafluoride Lipid Type A Microspheres 25 MG Injection Powder for Suspension [LUMASON] in people with Tetralogy of Fallot and Pulmonary Insufficiency, run by Nemours Children's Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of 3D Echocardiography Based Measurements of Right Ventricular Size Compared to MRI Derived Values. (time frame: 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.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05186415, which also lists 21 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2026.