Ultrasound Contrast Agents for Heart Imaging

No longer recruiting at 2 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Microvascular Therapeutics, LLC

Disqualifiers: Myocardial infarction, Unstable angina, Arrhythmia, COPD, others

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

Compensation: Varies

Number of Visits: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the safety and effectiveness of MVT-100, a new ultrasound contrast agent for heart imaging. Researchers compare it to an existing agent, Definity (also known as Perflutren Lipid Microsphere), to determine if it performs as well or better in enhancing the visibility of the heart's inner walls during ultrasound tests. The trial seeks healthy adults who have not experienced a heart attack in the past six months and do not have severe lung or heart issues. Participants will receive either MVT-100 or Definity and undergo heart imaging to assess the results. As a Phase 1, Phase 2 trial, this research aims to understand how the treatment works in people and measure its effectiveness in an initial, smaller group, offering participants a chance to contribute to groundbreaking heart imaging advancements.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

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

Research has shown that Definity, a contrast agent used for heart imaging, is generally safe, even for individuals with heart and lung conditions. Although rare, some serious heart and lung reactions have been reported. An allergic reaction to one of its ingredients has also been documented, but this is uncommon.

For MVT-100, the new contrast agent under testing, early studies have shown promising safety results. Research suggests it is safe, with lab tests supporting this. Like Definity, MVT-100 aims to improve heart imaging but uses a slightly different formula.

In summary, both Definity and MVT-100 have been generally well-tolerated in studies. While any contrast agent carries rare risks, the data so far suggest these treatments are safe for heart imaging. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these ultrasound contrast agents, Definity and MVT-100, because they could enhance heart imaging in a way current options don't. Unlike traditional echocardiography methods that rely on standard ultrasound waves alone, these agents improve the clarity and detail of heart images by helping to highlight blood flow and cardiac structures. This could lead to more accurate diagnoses and better treatment plans for heart conditions. Moreover, both agents are delivered in a unique way, with a controlled infusion that allows for consistent imaging quality, potentially making them more reliable than existing contrast agents.

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

Research has shown that Definity, an agent used in this trial, clarifies heart images by improving the view of the heart's left chamber. This agent employs tiny bubbles, a well-known technology, to enhance the accuracy of heart tests, particularly when initial images are unclear.

MVT-100, another agent in this trial, resembles Definity but has a slightly different composition. Researchers are studying its potential to improve heart imaging. Early results suggest that MVT-100 can also enhance heart images. This new agent uses tiny bubbles to reflect sound waves, potentially offering a better method to assess heart health. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

Healthy adults over 19, who can't have children or will use birth control, with normal blood counts and organ function. Excluded are those with recent heart attacks, unstable angina, severe heart failure, significant arrhythmias in the last six months, allergies to similar drugs or soy/egg products, participation in other trials within 30 days, conditions making lying flat for an hour difficult or certain lung issues.

Inclusion Criteria

I am 19 years old or older.

I am a woman who cannot become pregnant or I am using effective birth control.

Subject must be willing and able to understand the study and provide written Informed Consent to participate in the study

Exclusion Criteria

I have severe lung problems that aren't well-controlled by medication or need oxygen often.

You are allergic to perflutren or other echo contrast agents.

I do not have severe heart problems like unstable chest pain or heart failure.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either MVT-100 or Definity and undergo echocardiograms after administration via bolus or IV infusion

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1-2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Definity
• MVT-100

Trial Overview

The trial tests MVT-100 against Definity (both ultrasound contrast agents) in healthy volunteers using a single ascending dose method. Participants receive one of the two drugs and then undergo echocardiograms to assess safety and how well they help visualize the heart's inner lining during ultrasound.

How Is the Trial Designed?

Group I: MVT-100 Experimental Treatment 2 Interventions

Each subject receives 100 uL x 2, 200 uL x 3, 300 uL x 2 or 1 vial of MVT-100 diluted in 50 mL of NS as follows: Two milliliter bolus over 10 seconds prior to each infusion rate;, then infusions will run for 5 minutes at 60 mL per hour, 5 minutes at 90 mL per hour, 5 minutes at 100 mL per hour and 5 minutes at 120 mL per hour.

Group II: Definity Active Control 2 Interventions

Each subject receives 100 uL x 2, 200 uL x 3, 300 uL x 2 or 1 vial of DEFINITY® 100 diluted in 50 mL of NS as follows: Two milliliter bolus over 10 seconds prior to each infusion rate;, then infusions will run for 5 minutes at 60 mL per hour, 5 minutes at 90 mL per hour, 5 minutes at 100 mL per hour and 5 minutes at 120 mL per hour.

Who Is Running the Clinical Trial?

Microvascular Therapeutics, LLC

Lead Sponsor

Trials

2

Recruited

20+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

University of Nebraska

Collaborator

Trials

563

Recruited

1,147,000+

Published Research Related to This Trial

In the first year of using the second-generation contrast agent Definity in echocardiography, 161 patients showed a significant improvement in endocardial definition scores (p=0.0001), enhancing the clarity of heart imaging.

The use of contrast echocardiography led to the detection of clinically significant conditions that were missed in standard 2D imaging, with a very low adverse event rate of only 0.6%, indicating its safety and efficacy in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Contrast echocardiography in Australian clinical practice. Hamilton-Craig, C., Boga, T., West, C., et al.[2022]

In a study involving 4,786 patients undergoing stress echocardiography, the use of perflutren-based contrast agents like Definity and Optison did not increase the risk of severe adverse events compared to patients who did not receive contrast.

The rates of serious complications, including death within 24 hours and cardiac arrest, were similar between those receiving contrast and those who did not, indicating that the use of these contrast agents is generally safe in this context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of ultrasound contrast agents in stress echocardiography. Gabriel, RS., Smyth, YM., Menon, V., et al.[2015]

In response to serious safety concerns, including 4 patient deaths and 190 serious reactions, the FDA issued a 'black box' warning for ultrasound contrast agents Definity and Optison, leading to a significant decline in their use in the US.

Recent safety data and discussions from the FDA Cardio-Renal panel indicate ongoing evaluation of these agents, with revised labeling aimed at improving safety protocols for contrast echocardiography.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ultrasound contrast agents: balancing safety versus efficacy. Main, ML., Goldman, JH., Grayburn, PA.[2022]

Echocardiography, while commonly used to assess heart function, can be suboptimal in 15-20% of cases, but using ultrasound microbubble contrast like DEFINITY® significantly improves diagnostic accuracy and helps salvage nondiagnostic studies.

DEFINITY® is an FDA-approved microbubble contrast agent that enhances left ventricular imaging, providing clearer assessments of cardiac function and wall motion abnormalities, with a well-defined safety profile and clinical indications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Review of ultrasound contrast agents in current clinical practice with special focus on DEFINITY® in cardiac imaging. Salih, M., Ali, SM., Jena, N., et al.[2022]

A 73-year-old patient experienced sudden death shortly after receiving a perflutren contrast agent during an echocardiogram, highlighting potential risks associated with its use in patients with severe heart conditions.

Despite the timing of the death, autopsy results did not establish a direct link between the perflutren agent and the fatal event, suggesting that this case may represent a pseudocomplication rather than a direct adverse effect.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sudden death after intravenous administration of a perflutren contrast agent: a case of pseudocomplication? Mahjoub, H., Roméo, P., Leung, TK., et al.[2014]

In a study involving 1,060 patients, Definity (perflutren lipid microsphere) was found to be well tolerated, with no deaths or serious adverse events reported during or within 30 minutes after administration.

The overall adverse event rate was 10.8%, with a low drug-related adverse event rate of 3.5%, indicating that most adverse events were mild or moderate, making Definity a safe option for patients with suboptimal echocardiograms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

CaRES (Contrast Echocardiography Registry for Safety Surveillance): a prospective multicenter study to evaluate the safety of the ultrasound contrast agent definity in clinical practice. Weiss, RJ., Ahmad, M., Villanueva, F., et al.[2022]

In two patients with cardiac tamponade, echocardiographic-guided pericardiocentesis successfully drained bloody fluid, demonstrating the procedure's efficacy in managing this condition.

The use of Definity perflutren lipid microspheres as echocardiographic contrast during the procedure is a novel approach that enhanced the accuracy of needle placement, marking the first reported application of this technique.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perflutren microspheres for contrast echocardiography in a bloody pericardiocentesis. Escabí-Mendoza, JE., Martínez-Díaz, JD., Avilés-Rivera, ED.[2018]

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Demonstrating the Efficacy of DEFINITY® in Clinical Settings

Review clinical data showing how DEFINITY® improves diagnostic accuracy and patient outcomes in echocardiography.

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DEFINITY is a diagnostic ultrasound enhancing agent that uses advanced microbubble technology to opacify the left ventricular chamber.

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Office of Clinical Pharmacology Supplement Review

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Perflutren lipid microsphere injectable suspension for cardiac ...

Efficacy and safety of the novel ultrasound contrast agent perflutren (definity) in patients with suboptimal baseline left ventricular echocardiographic images.

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sciencedirect.com

sciencedirect.com/science/article/pii/S0002914924007975

Comparative Safety of Ultrasound Enhancing Agents

In the first study, death occurred within 24 hours in 1 of 5,947 echocardiograms performed using OPTISON (0.02%) and no death occurred in 12,802 ...

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definityimaging.com

definityimaging.com/safety

Safety Profile of DEFINITY® for Medical Imaging

DEFINITY® is demonstrated to be safe in patients with a high prevalence of cardiopulmonary disease and pulmonary hypertension.

7.

accessdata.fda.gov

accessdata.fda.gov/drugsatfda_docs/label/2021/021064s025s029lbl.pdf

Definity - accessdata.fda.gov

WARNING: SERIOUS CARDIOPULMONARY REACTIONS. See full prescribing information for complete boxed warning. Serious cardiopulmonary reactions, including ...

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mayoclinic.org

mayoclinic.org/drugs-supplements/perflutren-lipid-microsphere-intravenous-route/description/drg-20067608

Perflutren lipid microsphere (intravenous route)

Perflutren lipid microsphere injection is used during an echocardiogram to help diagnose or find problems in the heart.

9.

rxlist.com

rxlist.com/definity-drug.htm

Definity (Perflutren Lipid Microsphere): Side Effects, Uses, ...

Definity (perflutren lipid microsphere) Injectable Suspension is a contrast agent used to brighten and clarify images of the heart during echocardiograms.

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12060560/

Perflutren lipid microspheres for echocardiogram contrast

Anaphylaxis to perflutren lipid microsphere is very rare, with only one case report clearly attributing the reaction to the PEG excipient.