Heart DiseasePhase 3NCT02282163
Evaluation of Safety and Efficacy of Lumason in Pediatric Echocardiography
A Phase 3 study testing sulphur hexafluoride lipid-type A microspheres in people with Heart Disease, run by Bracco Diagnostics, Inc at 2 sites in United States.
Trial summary
Safety and Efficacy Study in pediatric subjects aged 9 to 17 years of age with suboptimal LV EBD on non-contrast 2D echocardiography. Imaging modalities that are used throughout the study in pediatric subjects represented those utilized in routine clinical practice in adults. Read more about this study
- Who is it for?
- Ages 9 to 17 years
- Conditions the study is for
- Heart Disease
- What is being tested?
- sulphur hexafluoride lipid-type A microspheres
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2015to Aug 2018
- Phase
- Phase 3
- 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 9 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Provide Written informed consent from parent(s) or legal guardian
- Provide assent when required according to local regulations
- Suspected of having cardiac disease or undergoing evaluation of cardiac anatomy for congenital heart disease
- Undergone a previous transthoracic echocardiogram within one month prior to enrollment resulting in suboptimal left ventricular endocardial border defined as ≥ 2 contiguous segments in any given view that cannot be visualized.
Who cannot join
- Children < 9 years of age
- Previously enrolled in the study
- Administered any other contrast agent either intravascularly or orally within 48 hours of Lumason administration
- Known right-to-left, bidirectional or transient cardiac shunt (ruled out with agitated saline study performed before administration of Lumason)
- Known hypersensitivity to one or more of the ingredients of the investigational product
- Received an investigational compound within 30 days before enrolling into this study
- Pregnant or lactating female
- Determined by investigator to be unsuitable for the study
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Nebraska
Omaha, Nebraska, 68114
Washington University School of Medicine in Saint Louis
St Louis, Missouri, 63110
About this study
Official title: A Multicenter Clinical Evaluation of Safety and Efficacy of Lumason as a Contrast Agent in Pediatric Echocardiography
Safety and Efficacy Study in pediatric subjects aged 9 to 17 years of age with suboptimal LV EBD on non-contrast 2D echocardiography. Imaging modalities that are used throughout the study in pediatric subjects represented those utilized in routine clinical practice in adults.
Read the detailed description
This was a Phase III, multicenter, open-label study that was to be conducted at approximately 7-12 sites in the United States, Canada and Europe in pediatric patients with suboptimal LV EBD on non-contrast 2D transthoracic echocardiography. It was estimated that 92 patients were to be enrolled to provide 73 evaluable patients.
Three cardiologists unaffiliated with enrolling centers (blinded readers), blinded to the patient's identity and clinical profile were to independently evaluate the echocardiograms. The efficacy analysis was primarily based on the blinded reader evaluations.
Imaging modalities that are used throughout the study in pediatric subjects represented those utilized in routine clinical practice in adults.
One of the sites participating in this study was to be asked to consent a subset of patients for additional blood sampling for analysis of SF6 concentration in blood from a total of 6 patients (3 males and 3 females) in the age group 9 up to 12 years of age and 6 patients (3 males and 3 females) in the age of >12 up to and including 17 years.
The current study was designed to assess the efficacy of Lumason-enhanced echocardiography in pediatric patients.
- Conditions
- Heart Disease
- Being tested
- sulphur hexafluoride lipid-type A microspheres
- Medical subject headings
- Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sulphur hexafluoride lipid-type A microspheresDrug
Also called Lumason, SonoVue
Ultrasound imaging contrast agent
| Study group | Role | What they receive |
|---|---|---|
| Lumason | Experimental | All patients were administered, Lumason (sulphur hexafluoride lipid-type A microspheres) an ultrasound contrast agent as a single 0.03 mL/kg bolus injection during echocardiography. Receives: Drug: sulphur hexafluoride lipid-type A microspheres |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Total Left Ventricular Endocardial Border Delineation (LV EBD) Scores
The total LV EBD score for a subject was the total of the EBD scores (Inadequate - 0, sufficient - 1, Good - 2) from the 17 segments (from the apical 4-chamber, apical 2-chamber and apical long (3-chamber) views, according to the guidelines of the American Society of Echocardiography). The total LV EBD scores could range from 0 to 34 and are presented below for each of the three readers for both unenhanced ultrasound (UEUS) and contrast-enhanced ultrasound (CEUS).
Change from baseline is the difference between UEUS and CEUS in total LV EBD scores.
Measured: Immediately post dose-Day 1
Percentage of Participants With Adequate Left Ventricular Opacification (LVO)
LVO was graded as 0 to +3, 4-point rating scale. Left ventricular opacification rating of +2 (non-homogeneous) or +3 (complete and homogeneous) was considered as adequate LVO.
Measured: Immediately post dose-Day 1
Secondary outcomes (1)
Number of Participants With Adverse Events
To obtain safety data in pediatric subjects administered Lumason for LV EBD improvement during echocardiography
Measured: Up to 72 hours post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2014 (estimated)
- Study startOct 2015
- Primary completion31 May 2018
- Study completionAug 2018
Why it stopped: FDA agreed to early termination due to difficulties enrolling patients.
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.
- Other trials for Heart DiseaseStudies 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 3
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bracco Diagnostics, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Melda Dolan, M.D., Study director, Bracco Diagnostics, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02282163
- Sponsor's protocol ID
- BR1-140
- Status last verified
- Jun 2020
- First submitted
- 30 Oct 2014
- Last updated
- 13 Jul 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Clinical Evaluation of Safety and Efficacy of Lumason as a Contrast Agent in Pediatric Echocardiography
- ClinicalTrials.gov ID
- NCT02282163
- Acronym / sponsor ID
- BR1-140
- Conditions
- Heart Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: FDA agreed to early termination due to difficulties enrolling patients.
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Bracco Diagnostics, IncIndustry (pharma, biotech, devices)
- Study start
- Oct 2015 (actual)
- Primary completion
- 31 May 2018 (actual)
- Study completion
- Aug 2018 (actual)
- First posted
- 4 Nov 2014 (estimated)
- Results
- Posted 16 Jun 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Safety and Efficacy Study in pediatric subjects aged 9 to 17 years of age with suboptimal LV EBD on non-contrast 2D echocardiography. Imaging modalities that are used throughout the study in pediatric subjects represented those utilized in routine clinical practice in adults.
Detailed description
This was a Phase III, multicenter, open-label study that was to be conducted at approximately 7-12 sites in the United States, Canada and Europe in pediatric patients with suboptimal LV EBD on non-contrast 2D transthoracic echocardiography. It was estimated that 92 patients were to be enrolled to provide 73 evaluable patients.
Three cardiologists unaffiliated with enrolling centers (blinded readers), blinded to the patient's identity and clinical profile were to independently evaluate the echocardiograms. The efficacy analysis was primarily based on the blinded reader evaluations.
Imaging modalities that are used throughout the study in pediatric subjects represented those utilized in routine clinical practice in adults.
One of the sites participating in this study was to be asked to consent a subset of patients for additional blood sampling for analysis of SF6 concentration in blood from a total of 6 patients (3 males and 3 females) in the age group 9 up to 12 years of age and 6 patients (3 males and 3 females) in the age of >12 up to and including 17 years.
The current study was designed to assess the efficacy of Lumason-enhanced echocardiography in pediatric patients.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lumason | Experimental | Drug: sulphur hexafluoride lipid-type A microspheresAll patients were administered, Lumason (sulphur hexafluoride lipid-type A microspheres) an ultrasound contrast agent as a single 0.03 mL/kg bolus injection during echocardiography. |
Who may qualify
- Ages
- 9 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Provide Written informed consent from parent(s) or legal guardian
- Provide assent when required according to local regulations
- Suspected of having cardiac disease or undergoing evaluation of cardiac anatomy for congenital heart disease
- Undergone a previous transthoracic echocardiogram within one month prior to enrollment resulting in suboptimal left ventricular endocardial border defined as ≥ 2 contiguous segments in any given view that cannot be visualized.
Key exclusion criteria (8 listed)
- Children < 9 years of age
- Previously enrolled in the study
- Administered any other contrast agent either intravascularly or orally within 48 hours of Lumason administration
- Known right-to-left, bidirectional or transient cardiac shunt (ruled out with agitated saline study performed before administration of Lumason)
- Known hypersensitivity to one or more of the ingredients of the investigational product
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 |
|---|---|---|
| sulphur hexafluoride lipid-type A microspheresAlso: Lumason, SonoVueUltrasound imaging contrast agent | Drug | Lumason |
Primary outcome
Change From Baseline in Total Left Ventricular Endocardial Border Delineation (LV EBD) Scores
Time frame: Immediately post dose-Day 1
The total LV EBD score for a subject was the total of the EBD scores (Inadequate - 0, sufficient - 1, Good - 2) from the 17 segments (from the apical 4-chamber, apical 2-chamber and apical long (3-chamber) views, according to the guidelines of the American Society of Echocardiography). The total LV EBD scores could range from 0 to 34 and are presented below for each of the three readers for both unenhanced ultrasound (UEUS) and contrast-enhanced ultrasound (CEUS). Change from baseline is the difference between UEUS and CEUS in total LV EBD scores.
Percentage of Participants With Adequate Left Ventricular Opacification (LVO)
Time frame: Immediately post dose-Day 1
LVO was graded as 0 to +3, 4-point rating scale. Left ventricular opacification rating of +2 (non-homogeneous) or +3 (complete and homogeneous) was considered as adequate LVO.
1 secondary outcome
Number of Participants With Adverse Events
Time frame: Up to 72 hours post dose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Melda Dolan, M.D. study director
Bracco Diagnostics, Inc
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing sulphur hexafluoride lipid-type A microspheres in people with Heart Disease, run by Bracco Diagnostics, Inc at 2 sites 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 4 inclusion and 8 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: stopped early, as of the sponsor's last update on 13 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 16 Jun 2020). 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?
Change From Baseline in Total Left Ventricular Endocardial Border Delineation (LV EBD) Scores (time frame: Immediately post dose-Day 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Jul 2020.