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An Ascending Dose Comparison of MVT-100 to Definity in Healthy Volunteers

Primary Purpose

Heart Diseases

Status

Recruiting

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Echocardiogram

MVT-100

Definity

About this trial

This is an interventional diagnostic trial for Heart Diseases focused on measuring echo, echocardiogram, Healthy Volunteers, Definity

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Saint Luke's Hospital of Kansas CityRecruiting
University of Nebraska Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Definity

MVT-100

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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: Δ2min QT interval EKG(MVT-100) ≤ Δ2min QT interval EKG(Definity®) HA: Δ2min Blood Pressure(MVT-100) ≤ Δ2min Blood Pressure(Definity®) HA: Δ2min Heart Rate(MVT-100) ≤ Δ2min Heart Rate(Definity®) HA: Δ2min O2(MVT-100) ≤ Δ2min O2(Definity®) HA: Other Symptom(2min post MVT-100) ≤ Other Symptom(2min post Definity®)

Blood Pressure

Heart Rate

Oxygen Saturation

Other Symptoms

Secondary Outcome Measures

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®)

Cardiac Segment Visualization

Full Information

NCT ID

NCT03882359

First Posted

February 15, 2019

Last Updated

March 30, 2023

Sponsor

Microvascular Therapeutics, LLC

Collaborators

National Heart, Lung, and Blood Institute (NHLBI), University of Nebraska

1. Study Identification

Unique Protocol Identification Number

NCT03882359

Brief Title

An Ascending Dose Comparison of MVT-100 to Definity in Healthy Volunteers

Official Title

MVT-100: Advancing the Clinical Use of Perflutren Ultrasound Contrast Agents for Suboptimal Echocardiograms

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Recruiting

Study Start Date

April 25, 2019 (Actual)

Primary Completion Date

December 31, 2024 (Anticipated)

Study Completion Date

December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Microvascular Therapeutics, LLC

Collaborators

National Heart, Lung, and Blood Institute (NHLBI), University of Nebraska

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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.

Detailed 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Heart Diseases

Keywords

echo, echocardiogram, Healthy Volunteers, Definity

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Model Description

Ascending dose comparison in healthy volunteers

Masking

Outcomes Assessor

Masking Description

The interpreter of echocardiograms in the trial is blinded to the drug which was administered, MVT-100 or Definity.

Allocation

Randomized

Enrollment

16 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Definity

Arm Type

Active Comparator

Arm Description

Arm Title

MVT-100

Arm Type

Experimental

Arm Description

Intervention Type

Diagnostic Test

Intervention Name(s)

Echocardiogram

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

MVT-100

Intervention Description

After randomization, MVT-100, the experimental drug, is administered via IV infusion or bolus administration and echocardiograms are subsequently obtained.

Intervention Type

Drug

Intervention Name(s)

Definity

Intervention Description

After randomization, Definity, the active comparator, is administered via IV infusion or bolus administration and echocardiograms are subsequently obtained.

Primary Outcome Measure Information:

Title

QT Interval

Description

Time Frame

Day of study

Title

Blood Pressure

Description

Time Frame

Day of study

Title

Heart Rate

Description

Time Frame

Day of study

Title

Oxygen Saturation

Description

Time Frame

Day of study

Title

Other Symptoms

Description

Time Frame

Day of study

Secondary Outcome Measure Information:

Title

Left Ventricular Opacification (LVO)

Description

Time Frame

Day of Study

Title

Cardiac Segment Visualization

Description

Time Frame

Day of Study

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Saint Luke's Hospital of Kansas City

City

Kansas City

State/Province

Missouri

ZIP/Postal Code

64111

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Michael Main, MD

Phone

816-931-1883

mmain@saint-lukes.org

First Name & Middle Initial & Last Name & Degree

Caroline W Murray, CCRC

Phone

816-932-2057

cwmurray@saint-lukes.org

Facility Name

University of Nebraska Medical Center

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68198

Country

United States

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Sharon Mclean

Phone

402-559-7977

smclean@unmc.edu

First Name & Middle Initial & Last Name & Degree

Tom Porter, MD

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

22692172

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.

Results Reference

background

PubMed Identifier

23764145

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.

Results Reference

background

Citation

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

Results Reference

background

Citation

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

Results Reference

background

PubMed Identifier

17765820

Citation

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.

Results Reference

background

PubMed Identifier

25085408

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.

Results Reference

background

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An Ascending Dose Comparison of MVT-100 to Definity in Healthy Volunteers

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