Lumason Administration Methods for Heart Disease

Not yet recruiting at 2 trial locations

Overseen By Audrey Sahns

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Bracco Diagnostics, Inc

Disqualifiers: Severe heart failure, Uncontrolled angina, Recent myocardial infarction, Severe arrhythmia, Severe pulmonary hypertension, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 2-3 hours

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine the best method for administering Lumason®, a treatment for heart disease, by comparing a quick shot (bolus) and a slow, continuous drip (infusion). The researchers seek to identify which method improves heart imaging results more effectively. Suitable participants are adults with heart conditions that obscure parts of their heart during an ultrasound. As a Phase 3 trial, this study represents the final step before FDA approval, allowing participants to contribute to the validation of a potentially groundbreaking treatment.

Do I need to stop my current medications for the trial?

The trial information does not specify if you need to stop your current medications. However, if you have uncontrolled angina or have been treated with another contrast medium recently, you may not be eligible to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Lumason, a drug used for heart imaging, has a very low death rate of just 0.03% in patients who received it, which is lower than in those who did not receive the drug. However, serious reactions, including some heart and lung problems, have rarely occurred. These reactions are uncommon but can be serious. The two methods being studied—bolus administration (a quick injection) and continuous infusion (slowly given over time)—carry similar risks because they use the same drug. Lumason is already FDA-approved for certain uses, indicating it is generally considered safe when used as directed. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Lumason® administration methods for heart disease because they explore new ways to deliver the treatment more effectively. Unlike standard ultrasound contrast agents that are typically administered via a single bolus injection, this trial compares a bolus administration of 2 mL of undiluted Lumason® with a continuous infusion of 8 mL of diluted Lumason®. The continuous infusion method is particularly intriguing because it could potentially provide a more consistent contrast enhancement during cardiac imaging, which might improve the accuracy of heart disease diagnosis. By testing these two methods, researchers hope to determine which is more efficient and beneficial for patients, potentially leading to better outcomes in heart disease management.

What evidence suggests that this trial's treatments could be effective for heart disease?

Research has shown that Lumason® improves heart imaging, allowing doctors to see the heart's structure and function more clearly. In this trial, participants will receive Lumason® either through bolus administration, a quick injection of 2 mL undiluted Lumason®, or through continuous infusion, a slow, steady drip of 8 mL diluted Lumason®. Studies have found that Lumason® greatly enhances the view of the heart's left ventricle, aiding in the diagnosis of heart conditions. Additionally, real-world evidence supports its safety and effectiveness, indicating a lower risk of death when used in heart imaging. These findings suggest Lumason® is a dependable tool for assessing heart health. ^{1 3 6 7 8}

Who Is on the Research Team?

Jose Banchs, MD

Principal Investigator

Sr. Medical Director

Are You a Good Fit for This Trial?

This trial is for individuals with heart disease who can safely receive Lumason, a diagnostic drug used in ultrasounds. Participants must be eligible based on specific health criteria not detailed here.

Inclusion Criteria

Provide their written informed consent and are willing to comply with protocol requirements

My heart's left ventricle has areas that can't be seen clearly on an echo without contrast.

Exclusion Criteria

Has any known allergy to one or more of the ingredients of the investigational product

Is determined by the Investigator that the patient is clinically unsuitable for the study

Has previously entered the study or have received any other investigational drug within 30 days prior to admission in this study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Randomized, within-patient comparison of continuous infusion of diluted Lumason® versus bolus administration of undiluted Lumason®

2-3 hours

1 visit (in-person)

Follow-up

Participants are monitored for adverse events and effectiveness after treatment

24 hours

What Are the Treatments Tested in This Trial?

Interventions

• Lumason®

Trial Overview The study compares two ways of giving Lumason: a continuous diluted infusion versus a single concentrated dose (bolus). It measures how well each method shows left ventricular opacification and endocardial border definition during an ultrasound.

How Is the Trial Designed?

Group I: Continuous infusion Experimental Treatment 1 Intervention

Continuous infusion of 8 mL of diluted Lumason®

Group II: Bolus administration Active Control 1 Intervention

Bolus administration of 2 mL undiluted Lumason®

Who Is Running the Clinical Trial?

Bracco Diagnostics, Inc

Lead Sponsor

Trials

62

Recruited

9,500+

Diana Bracco

Bracco Diagnostics, Inc

Chief Executive Officer since 1999

Degree in Chemistry from the University of Pavia

Alberto Spinazzi

Bracco Diagnostics, Inc

Chief Medical Officer since 2023

MD

Citations

1. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2021/203684s009lbl.pdf

Lumason - accessdata.fda.gov WARNING: SERIOUS CARDIOPULMONARY REACTIONS. Serious cardiopulmonary reactions, including fatalities, have occurred uncommonly during or following the injection ...

2. bracco.com bracco.com/en-us/media/3810

New Nationwide Real-World Data Validates the Safety of ... Lower odds of death when LUMASON® (an injectable suspension, sulphur hexafluoride lipid-type A microsphere for intravenous and intravesical ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT02282163

Evaluation of Safety and Efficacy of Lumason in Pediatric ... All patients were administered, Lumason (sulphur hexafluoride lipid-type A microspheres) an ultrasound contrast agent as a single 0.03 mL/kg bolus injection ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4676450/

Update on the safety and efficacy of commercial ultrasound ... The present review focuses on the use of UCAs in today's clinical practice, including the approved indications, a variety of off-label uses, and the most ...

5. asecho.org asecho.org/wp-content/uploads/2019/07/2018-LUMASON-Formulary-Kit-APPROVED.pdf

LUMASON FORMULARY KIT Serious cardiopulmonary reactions, including fatalities, have occurred uncommonly during or following the injection of ultrasound contrast agents, including ...

6. lumason.com lumason.com/safety/

Safety Patients who received LUMASON UEA had a mortality rate of only 0.03%—lower than in those who didn't receive a UEA.

7. mayoclinic.org mayoclinic.org/drugs-supplements/sulfur-hexafluoride-lipid-type-a-microspheres-injection-route-intravenous-route/description/drg-20405988

Sulfur hexafluoride lipid type a microspheres (injection ... Sulfur hexafluoride lipid type A microspheres injection is used during an echocardiogram to help diagnose or find problems in the heart.

8. clinicaltrials.gov clinicaltrials.gov/study/NCT02282163

Evaluation of Safety and Efficacy of Lumason in Pediatric ... All patients were administered, Lumason (sulphur hexafluoride lipid-type A microspheres) an ultrasound contrast agent as a single 0.03 mL/kg bolus injection ...