Ultrasound Contrast Agents for Heart Imaging

Recruiting in Palo Alto (17 mi)

+2 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Microvascular Therapeutics, LLC

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial tests MVT-100, a new ultrasound contrast agent, in healthy volunteers. It aims to see if MVT-100 is safe and effective for improving heart images by using tiny bubbles that reflect ultrasound waves. The study compares MVT-100 to an existing product.

Research Team

Eligibility Criteria

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

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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.

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Treatment Details

Interventions

Definity (Ultrasound Contrast Agent)
MVT-100 (Ultrasound Contrast Agent)

Trial OverviewThe 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.

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: MVT-100Experimental Treatment2 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: DefinityActive Control2 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.