A Single Ascending Dose Comparison of MVT-100 With Definity in Healthy Volunteers
Status: | Not yet recruiting |
---|---|
Conditions: | Peripheral Vascular Disease, Cardiology |
Therapuetic Areas: | Cardiology / Vascular Diseases |
Healthy: | No |
Age Range: | 19 - Any |
Updated: | 3/22/2019 |
Start Date: | March 31, 2019 |
End Date: | December 31, 2019 |
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.
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.
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
- Evaluation of endocardial border delineation
- Evaluation of endocardial border length
- Evaluation of duration of useful contrast
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
- Evaluation of endocardial border delineation
- Evaluation of endocardial border length
- Evaluation of duration of useful contrast
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 right-to-left, bi-directional, or transient right-to-left cardiac shunts
- 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
We found this trial at
2
sites
Tucson, Arizona 85721
(520) 621-2211
Principal Investigator: Raj Janardnanan, MD
Phone: 520-624-6688
University of Arizona The University of Arizona is a premier, public research university. Established in...
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Emile St
Omaha, Nebraska 68198
Omaha, Nebraska 68198
(402) 559-4000
Principal Investigator: Tom Porter, MD
Phone: 402-559-7977
Univ of Nebraska Med Ctr A vital enterprise in the nation’s heartland, the University of...
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