An Ascending Dose Comparison of MVT-100 to Definity in Healthy Volunteers
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 32
Summary
- Conditions
- Heart Diseases
- Type
- Interventional
- Phase
- Phase 1Phase 2
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Ascending dose comparison in healthy volunteersMasking: Single (Outcomes Assessor)Masking Description: The interpreter of echocardiograms in the trial is blinded to the drug which was administered, MVT-100 or Definity.Primary Purpose: Diagnostic
Participation Requirements
- Age
- Between 19 years and 125 years
- Gender
- Both males and females
Description
Ultrasound is one of the most common imaging examinations and has advantages of absence of ionizing radiation, portability and relatively low cost. Ultrasound contrast agents are used to improve the accuracy of ultrasound and Definity (perflutren) is the world's leading ultrasound contrast agent but...
Ultrasound is one of the most common imaging examinations and has advantages of absence of ionizing radiation, portability and relatively low cost. Ultrasound contrast agents are used to improve the accuracy of ultrasound and Definity (perflutren) is the world's leading ultrasound contrast agent but perflutren has to be refrigerated and has a side effect of back pain. The investigators have developed a new, improved perflutren, MVT-100, with potential for room temperature storage. Ultrasound contrast agents are used to increase the backscatter (signal intensity of blood vessels and tissues to improve diagnostic accuracy) of ultrasound imaging. In the US ultrasound contrast agents are FDA approved for echocardiography to improve endomyocardial border definition. MVT-100 reflects the ultrasound to provide strong back-scattering. MVT-100 microbubbles resonate with ultrasound to provide strong harmonic signals. MVT-100 microbubbles will cavitate with higher levels of ultrasound and cavitation may be stable or inertial depending upon acoustic parameters and other factors. The study is a multi centre ascending dose comparison of Definity and MVT-100 for use in echocardiography and will be performed in a sample of healthy volunteers who are randomized to receive either Definity or MVT-100. This trial will assess safety and evaluate the following imaging metrics: Determine the optimal dose of MVT-100 by comparing MVT-100 vs Definity in the change from baseline of quantitative left ventricular opacification Evaluation of qualitative left ventricular opacification (LVO) Evaluation of endocardial border delineation Evaluation of endocardial border length Evaluation of duration of useful contrast
Tracking Information
- NCT #
- NCT03882359
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- University of Nebraska
- Investigators
- Not Provided
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