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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03882359
Other study ID # 00029941
Secondary ID 1R44HL137447-01A
Status Recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date April 25, 2019
Est. completion date December 31, 2024

Study information

Verified date March 2023
Source Microvascular Therapeutics, LLC
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Definity (perflutren lipid microspheres, Lantheus Medical Imaging) is an ultrasound contrast indicated for use in patients with suboptimal echocardiograms to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border. MVT-100 (the investigational pharmaceutical) is similar to Definity, with the exception of the removal of one lipid in the lipid blend and substitution of another lipid. This study is intended to evaluate the safety and efficacy of MVT-100 using a single ascending dose design in healthy volunteers. Patients are randomized to receive either MVT-100 or Definity and undergo echocardiograms after receiving either MVT-100 or Definity via bolus or IV infusion administration. The primary endpoints evaluated are safety and endocardial border delineation.


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 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


Recruitment information / eligibility

Status Recruiting
Enrollment 16
Est. completion date December 31, 2024
Est. primary completion date December 31, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 19 Years and older
Eligibility Inclusion Criteria: - Adult subjects 19 years of age or older, male or female - Female subjects must no longer have child-bearing potential (>1-year post menopause or surgically sterilized), or must - have a negative urine pregnancy test, and - be using and continue to use for 30 days after the study a medically effective method of contraception - Adequate hematologic, renal and hepatic function, as defined by: - Absolute neutrophil count (ANC) = 1.5 x 109/L - Platelet count = 100 x 109/L - Hemoglobin = 90 g/L - Plasma creatinine< 1.5 x ULN - Total bilirubin within normal limits (< 2.5 x ULN if Gilbert's syndrome) - Aspartate transaminase (AST) and Alanine transaminase (ALT) < 2.5 x ULN - Subject must be willing and able to understand the study and provide written Informed Consent to participate in the study Exclusion Criteria: - Myocardial infarction within six months prior to enrollment - Unstable angina, NYHA Class II or greater congestive heart failure - EKG evidence of uncontrolled arrhythmia or history of clinically significant arrhythmia within the past six months - Clinically significant Chronic Obstructive Pulmonary Disease (COPD) or other pulmonary condition that is not controlled by medication or requires oxygen frequently or continuously - A history of pulmonary emboli - Known hypersensitivity to perflutren, DEFINITY® or other echo contrast agent - Inability to remain supine for 60 minutes - Oxygen saturation < 95% on room air - History of allergic reaction attributed to compounds of similar chemical composition to MVT-100 or DEFINITY® or soy or egg allergies (see Investigator's Brochure) - Subject has received any investigational drug within thirty (30) days prior to enrollment into the study - Inability to comply with study procedures - Subjects with any medical condition deemed by the investigator to make the subject inappropriate for participation

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Echocardiogram
Images will be recorded in parasternal long, short axis, apical four, two, and three chamber views according to the American Society of Echocardiography (ASE) 17 segment model. Each assessment will include one round of low MI imaging (<0.3) and one round of very low MI imaging (<0.2) in each of the pre-specified windows according to the 2014 ASE Sonographer Guidelines. A baseline echocardiogram will be performed prior to the administration of DEFINITY® or MVT-100. Assessments will be made three times, once from 0 - 1 ½ minutes following injection, once between 1 ½ minutes to 3 minutes following IV injection and once from 3 - 4 ½ minutes following IV injection. Assessments at each time point will include one round of low MI imaging (<0.3) and one round of very low MI imaging (<0.2). Each round will include the views in the following order: parasternal long, parasternal short, apical 4, apical 2 and apical 3.
Drug:
MVT-100
After randomization, MVT-100, the experimental drug, is administered via IV infusion or bolus administration and echocardiograms are subsequently obtained.
Definity
After randomization, Definity, the active comparator, is administered via IV infusion or bolus administration and echocardiograms are subsequently obtained.

Locations

Country Name City State
United States Saint Luke's Hospital of Kansas City Kansas City Missouri
United States University of Nebraska Medical Center Omaha Nebraska

Sponsors (3)

Lead Sponsor Collaborator
Microvascular Therapeutics, LLC National Heart, Lung, and Blood Institute (NHLBI), University of Nebraska

Country where clinical trial is conducted

United States, 

References & Publications (6)

Lantheus Medical Imaging. Definity Package Insert. Definity Imaging. [Online] http://www.definityimaging.com/pdf/DEFINITY_US_PI_515987-0117.pdf.

Pellikka PA, Nagueh SF, Elhendy AA, Kuehl CA, Sawada SG; American Society of Echocardiography. American Society of Echocardiography recommendations for performance, interpretation, and application of stress echocardiography. J Am Soc Echocardiogr. 2007 Sep;20(9):1021-41. doi: 10.1016/j.echo.2007.07.003. No abstract available. — View Citation

Platts DG, Luis SA, Roper D, Burstow D, Call T, Forshaw A, Pascoe R. The safety profile of perflutren microsphere contrast echocardiography during rest and stress imaging: results from an Australian multicentre cohort. Heart Lung Circ. 2013 Dec;22(12):996-1002. doi: 10.1016/j.hlc.2013.05.637. Epub 2013 Jun 10. — View Citation

Porter TR, Abdelmoneim S, Belcik JT, McCulloch ML, Mulvagh SL, Olson JJ, Porcelli C, Tsutsui JM, Wei K. Guidelines for the cardiac sonographer in the performance of contrast echocardiography: a focused update from the American Society of Echocardiography. J Am Soc Echocardiogr. 2014 Aug;27(8):797-810. doi: 10.1016/j.echo.2014.05.011. No abstract available. — View Citation

Smith-Bindman R, Miglioretti DL, Johnson E, Lee C, Feigelson HS, Flynn M, Greenlee RT, Kruger RL, Hornbrook MC, Roblin D, Solberg LI, Vanneman N, Weinmann S, Williams AE. Use of diagnostic imaging studies and associated radiation exposure for patients enrolled in large integrated health care systems, 1996-2010. JAMA. 2012 Jun 13;307(22):2400-9. doi: 10.1001/jama.2012.5960. — View Citation

Weissman, Neil J., Warren J. Manning, and Brian C. Downey. Contrast echocardiography: clinical applications. Waltham, MA : UpToDate, 2013.

Outcome

Type Measure Description Time frame Safety issue
Primary QT Interval The null hypothesis for safety (H0) will be: MVT-100 is not as safe as DEFINITY®. The alternative hypothesis (HA) for safety will be: MVT-100 is equivalent to, or safer than, DEFINITY®. Specifically, the following hypotheses will be tested:
HA: ?2min QT interval EKG(MVT-100) = ?2min QT interval EKG(Definity®) HA: ?2min Blood Pressure(MVT-100) = ?2min Blood Pressure(Definity®) HA: ?2min Heart Rate(MVT-100) = ?2min Heart Rate(Definity®) HA: ?2min O2(MVT-100) = ?2min O2(Definity®) HA: Other Symptom(2min post MVT-100) = Other Symptom(2min post Definity®)
Day of study
Primary Blood Pressure The null hypothesis for safety (H0) will be: MVT-100 is not as safe as DEFINITY®. The alternative hypothesis (HA) for safety will be: MVT-100 is equivalent to, or safer than, DEFINITY®. Specifically, the following hypotheses will be tested:
HA: ?2min QT interval EKG(MVT-100) = ?2min QT interval EKG(Definity®) HA: ?2min Blood Pressure(MVT-100) = ?2min Blood Pressure(Definity®) HA: ?2min Heart Rate(MVT-100) = ?2min Heart Rate(Definity®) HA: ?2min O2(MVT-100) = ?2min O2(Definity®) HA: Other Symptom(2min post MVT-100) = Other Symptom(2min post Definity®)
Day of study
Primary Heart Rate The null hypothesis for safety (H0) will be: MVT-100 is not as safe as DEFINITY®. The alternative hypothesis (HA) for safety will be: MVT-100 is equivalent to, or safer than, DEFINITY®. Specifically, the following hypotheses will be tested:
HA: ?2min QT interval EKG(MVT-100) = ?2min QT interval EKG(Definity®) HA: ?2min Blood Pressure(MVT-100) = ?2min Blood Pressure(Definity®) HA: ?2min Heart Rate(MVT-100) = ?2min Heart Rate(Definity®) HA: ?2min O2(MVT-100) = ?2min O2(Definity®) HA: Other Symptom(2min post MVT-100) = Other Symptom(2min post Definity®)
Day of study
Primary Oxygen Saturation The null hypothesis for safety (H0) will be: MVT-100 is not as safe as DEFINITY®. The alternative hypothesis (HA) for safety will be: MVT-100 is equivalent to, or safer than, DEFINITY®. Specifically, the following hypotheses will be tested:
HA: ?2min QT interval EKG(MVT-100) = ?2min QT interval EKG(Definity®) HA: ?2min Blood Pressure(MVT-100) = ?2min Blood Pressure(Definity®) HA: ?2min Heart Rate(MVT-100) = ?2min Heart Rate(Definity®) HA: ?2min O2(MVT-100) = ?2min O2(Definity®) HA: Other Symptom(2min post MVT-100) = Other Symptom(2min post Definity®)
Day of study
Primary Other Symptoms The null hypothesis for safety (H0) will be: MVT-100 is not as safe as DEFINITY®. The alternative hypothesis (HA) for safety will be: MVT-100 is equivalent to, or safer than, DEFINITY®. Specifically, the following hypotheses will be tested:
HA: ?2min QT interval EKG(MVT-100) = ?2min QT interval EKG(Definity®) HA: ?2min Blood Pressure(MVT-100) = ?2min Blood Pressure(Definity®) HA: ?2min Heart Rate(MVT-100) = ?2min Heart Rate(Definity®) HA: ?2min O2(MVT-100) = ?2min O2(Definity®) HA: Other Symptom(2min post MVT-100) = Other Symptom(2min post Definity®)
Day of study
Secondary Left Ventricular Opacification (LVO) The null hypothesis for efficacy (H0) will be: MVT-100 is not as effective as DEFINITY®. The alternative hypothesis (HA) for efficacy will be: MVT-100 is equivalently or more effective than DEFINITY®. Specifically, the following hypotheses will be tested:
HA: LVO(MVT-100) = LVO(Definity®) HA: SegmentVisualization(MVT-100) = SegmentVisualization(Definity®)
Day of Study
Secondary Cardiac Segment Visualization The null hypothesis for efficacy (H0) will be: MVT-100 is not as effective as DEFINITY®. The alternative hypothesis (HA) for efficacy will be: MVT-100 is equivalently or more effective than DEFINITY®. Specifically, the following hypotheses will be tested:
HA: LVO(MVT-100) = LVO(Definity®) HA: SegmentVisualization(MVT-100) = SegmentVisualization(Definity®)
Day of Study
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