Heart DiseasesPhase 3NCT06400004
Lumason® Infusion vs. Bolus Administrations
A Phase 3 study testing Sulfur Hexafluoride Lipid Type A Microspheres 25 MG Injection Powder for Suspension [LUMASON] and Lumason in people with Heart Diseases, run by Bracco Diagnostics, Inc at 6 sites in United States.
Trial summary
A phase III study designed as a randomized, within-patient comparison of continuous infusion of diluted Lumason® versus the bolus administration of undiluted Lumason® for degree of LVO and assessment of LV EBD (co-primary endpoints). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Diseases
- What is being tested?
- Sulfur Hexafluoride Lipid Type A Microspheres 25 MG Injection Powder for Suspension [LUMASON] and Lumason
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 6 sitesUnited States
- Study dates
- 10 Jul 2024to 31 Dec 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Are at least 18-years old;
- Have suboptimal LV EBD, defined as ≥2 adjacent segments in any apical view that cannot be visualized, at pre-contrast echocardiogram;
- Provide their written informed consent and are willing to comply with protocol requirements.
Who cannot join
- Patient has severe congestive heart failure (class IV according to the classification of the New York Heart Association);
- Patient has uncontrolled angina (i.e., uncontrolled on medication);
- Patient had a recent myocardial infarction (within the last 3 days and not stabilized);
- Patient has severe arrhythmia, that in the opinion of the Investigator, would interfere with the study conduct;
- Patient has severe pulmonary hypertension, that in the opinion of the Investigator, would interfere with the study conduct;
- Patient had been treated with any other contrast medium, either intravascular or orally, within 48 hours prior to the first administration;
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- Has any known allergy to one or more of the ingredients of the investigational product;
- Is pregnant or lactating. Exclude the possibility of pregnancy by: testing on site (serum or urine βHCG) prior to the start of investigational product administration; surgical history (e.g., tubal ligation or hysterectomy); post-menopausal with a minimum 1 year without menses;
- Has previously entered the study or have received any other investigational drug within 30 days prior to admission in this study;
- Is determined by the Investigator that the patient is clinically unsuitable for the study.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
United States6 sites, 5 recruiting
- Recruiting
Piedmont Heart Institute
Atlanta, Georgia, 30309
Suzanne Corley, 404-605-3118, suzanne.corley@piedmont.org
Venkateshwar Polsani, MD
- Recruiting
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Constance Angell-James, MPH, cangellj@bidmc.harvard.edu
Madeline Cassidy, mcassid6@bidmc.harvard.edu
- Withdrawn
University of Texas Medical Branch
Galveston, Texas, 77555
- Recruiting
Vital Heart and Vein
Humble, Texas, 77338
Ovee Muhebb, 281-572-0109, s.muhebb@vitalheartandvein.com
Patrick Kee, MD
- Not yet recruiting
Oregon Health and Sciences University
Portland, Oregon, 97239
Amy Koski, 503-360-6705, koskia@ohsu.edu
David German, MD
- Recruiting
Interventional Cardiology Medical Group
West Hills, California, 91307
Michael Fam, MD, 818-743-0666, mfam@elegantrd.com
Farhad Rafii, MD
About this study
Official title: A Phase III Crossover Study to Evaluate Bolus Versus Continuous Infusion of Lumason® in Patients With Suboptimal Unenhanced Echocardiography
A phase III study designed as a randomized, within-patient comparison of continuous infusion of diluted Lumason® versus the bolus administration of undiluted Lumason® for degree of LVO and assessment of LV EBD (co-primary endpoints).
Read the detailed description
This is a phase III study designed as a randomized, within-patient comparison of continuous infusion of diluted Lumason® versus the bolus administration of undiluted Lumason® for degree of LVO and assessment of LV EBD (co-primary endpoints). The study will enroll patients with suboptimal LV EBD defined as ≥2 adjacent segments in any apical view that cannot be visualized at pre-contrast echocardiogram.
- Conditions
- Heart Diseases
- Being tested
- Sulfur Hexafluoride Lipid Type A Microspheres 25 MG Injection Powder for Suspension [LUMASON], Lumason
- Medical subject headings
- Heart Diseases
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
Also called Bolus Administration
Bolus administration of 2 mL undiluted Lumason®, to be administered in 20 seconds
LumasonDrug
Also called Infusion Administration
Continuous infusion of 8 mL of diluted Lumason® (4 mL of Lumason® diluted in 4 mL of saline) at a rate of 1.0 mL/min
| Study group | Role | What they receive |
|---|---|---|
| Bolus administration | Active comparator | Bolus administration of 2 mL undiluted Lumason® Receives: Drug: Sulfur Hexafluoride Lipid Type A Microspheres 25 MG Injection Powder for Suspension [LUMASON] |
| Continuous infusion | Experimental | Continuous infusion of 8 mL of diluted Lumason® Receives: Drug: Lumason |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adequate LV EBD Score
Compare the proportion of patients with adequate LV EBD score for infusion vs. bolus administrations in patients with suboptimal left ventricular endocardial border delineation at unenhanced echocardiography.
Measured: 2-3 Hours
Adequate LV Opacification
Compare the proportion of patients with adequate LV opacification for infusion vs. bolus administrations in patients with suboptimal left ventricular endocardial border delineation at unenhanced echocardiography.
Measured: 2-3 Hours
Secondary outcomes (2)
Clinically useful LVO
To compare the duration of clinically useful LVO in infusion vs. bolus administrations in terms of duration
Measured: 2-3 Hours
Adverse events
Compare adverse event rate after infusion vs. bolus administrations
Measured: 24 Hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2024
- Study start10 Jul 2024
- Primary completion29 Aug 2026
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart DiseasesStudies 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
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 106 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bracco Diagnostics, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jose Banchs, MD, Study director, Sr. Medical Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06400004
- Sponsor's protocol ID
- BR1-149
- Status last verified
- Mar 2026
- First submitted
- 23 Apr 2024
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Crossover Study to Evaluate Bolus Versus Continuous Infusion of Lumason® in Patients With Suboptimal Unenhanced Echocardiography
- ClinicalTrials.gov ID
- NCT06400004
- Acronym / sponsor ID
- BR1-149
- Conditions
- Heart Diseases
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 106 participants (estimated)
- Lead sponsor
- Bracco Diagnostics, IncIndustry (pharma, biotech, devices)
- Study start
- 10 Jul 2024 (actual)
- Primary completion
- 29 Aug 2026 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 6 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A phase III study designed as a randomized, within-patient comparison of continuous infusion of diluted Lumason® versus the bolus administration of undiluted Lumason® for degree of LVO and assessment of LV EBD (co-primary endpoints).
Detailed description
This is a phase III study designed as a randomized, within-patient comparison of continuous infusion of diluted Lumason® versus the bolus administration of undiluted Lumason® for degree of LVO and assessment of LV EBD (co-primary endpoints). The study will enroll patients with suboptimal LV EBD defined as ≥2 adjacent segments in any apical view that cannot be visualized at pre-contrast echocardiogram.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bolus administration | Active comparator | Drug: Sulfur Hexafluoride Lipid Type A Microspheres 25 MG Injection Powder for Suspension [LUMASON]Bolus administration of 2 mL undiluted Lumason® |
| Continuous infusion | Experimental | Drug: LumasonContinuous infusion of 8 mL of diluted Lumason® |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Are at least 18-years old;
- Have suboptimal LV EBD, defined as ≥2 adjacent segments in any apical view that cannot be visualized, at pre-contrast echocardiogram;
- Provide their written informed consent and are willing to comply with protocol requirements.
Key exclusion criteria (10 listed)
- Patient has severe congestive heart failure (class IV according to the classification of the New York Heart Association);
- Patient has uncontrolled angina (i.e., uncontrolled on medication);
- Patient had a recent myocardial infarction (within the last 3 days and not stabilized);
- Patient has severe arrhythmia, that in the opinion of the Investigator, would interfere with the study conduct;
- Patient has severe pulmonary hypertension, that in the opinion of the Investigator, would interfere with the study conduct;
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]Also: Bolus AdministrationBolus administration of 2 mL undiluted Lumason®, to be administered in 20 seconds | Drug | Bolus administration |
| LumasonAlso: Infusion AdministrationContinuous infusion of 8 mL of diluted Lumason® (4 mL of Lumason® diluted in 4 mL of saline) at a rate of 1.0 mL/min | Drug | Continuous infusion |
Primary outcome
Adequate LV EBD Score
Time frame: 2-3 Hours
Compare the proportion of patients with adequate LV EBD score for infusion vs. bolus administrations in patients with suboptimal left ventricular endocardial border delineation at unenhanced echocardiography.
Adequate LV Opacification
Time frame: 2-3 Hours
Compare the proportion of patients with adequate LV opacification for infusion vs. bolus administrations in patients with suboptimal left ventricular endocardial border delineation at unenhanced echocardiography.
2 secondary outcomes
Clinically useful LVO
Time frame: 2-3 Hours
Adverse events
Time frame: 24 Hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- 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.
Jose Banchs, MD study director
Sr. Medical Director
6 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 Sulfur Hexafluoride Lipid Type A Microspheres 25 MG Injection Powder for Suspension [LUMASON] and Lumason in people with Heart Diseases, run by Bracco Diagnostics, Inc at 6 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 3 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rushil Sankpal (609-514-2267, rushil.sankpal@diag.bracco.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adequate LV EBD Score (time frame: 2-3 Hours). 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 20 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.