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Unable to reliably reproduce, visualize, or quantify microvascular flow in the subcutaneous tissue, the skeletal muscle or peri-adventitia
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The purpose of this study is to test a method of imaging (taking a picture) of the abdomen (belly), neck, thigh and calf (lower leg) areas of the body, using ultrasound along with a drug which makes the pictures look clearer. Ultrasound is a type of imaging that uses sound waves to create a picture of the inside of the human body. Two sets of pictures will be taken on two different days to see if the results are the same each time.
DEFINITY® is a drug given intravenously (through the vein). DEFINITY® is approved by the FDA to be used as an ultrasound contrast agent (makes the pictures look clearer) while taking pictures of the heart. In this study, DEFINITY® will be used while taking pictures of blood vessels in your abdomen (belly), neck, thigh and calf (lower leg). Since this use of DEFINITY® is different than the use approved by the FDA, this study will be performed under an FDA Investigational New Drug (IND) application.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lean Healthy Subjects | Other | "Lean" defined as (BMI ≥18 and ≤25) |
|
| Obese Healthy Subjects | Other | Obese grade I-II defined as (BMI>30 and ≤35) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Perflutren Lipid Microsphere Injectable Suspension | Drug | 1.3 mL activated DEFINITY® diluted in 50 mL of preservative-free saline will be used |
|
| Measure | Description | Time Frame |
|---|---|---|
| Variability of Repeated Measures for Each Subject | The variability of repeated measures for each subject, expressed as coefficient of variation (CV), in the periadventitial microvascular flow, subcutaneous microvascular flow and skeletal muscle flow. | up to 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Microvascular Flow in the Periadventitial, Subcutaneous and Skeletal Muscle Tissues | up to 30 days |
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Inclusion Criteria:
Exclusion Criteria:
Subjects must not have been diagnosed with:
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| Name | Affiliation | Role |
|---|---|---|
| Muredach P Reilly, MB, MSCE | University of Pennsylvania | Principal Investigator |
| Luis H. Eraso, MD, MPH | University of Pennsylvania | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical and Translational Research Center | Philadelphia | Pennsylvania | 19104 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Lean Healthy Subjects | "Lean" defined as (BMI ≥18 and ≤25) Perflutren Lipid Microsphere Injectable Suspension: 1.3 mL activated DEFINITY® diluted in 50 mL of preservative-free saline will be used |
| FG001 | Obese Healthy Subjects | Obese grade I-II defined as (BMI>30 and ≤35) Perflutren Lipid Microsphere Injectable Suspension: 1.3 mL activated DEFINITY® diluted in 50 mL of preservative-free saline will be used |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Lean Healthy Subjects | "Lean" defined as (BMI ≥18 and ≤25) Perflutren Lipid Microsphere Injectable Suspension: 1.3 mL activated DEFINITY® diluted in 50 mL of preservative-free saline will be used |
| BG001 | Obese Healthy Subjects |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Variability of Repeated Measures for Each Subject | The variability of repeated measures for each subject, expressed as coefficient of variation (CV), in the periadventitial microvascular flow, subcutaneous microvascular flow and skeletal muscle flow. | Reliable data for periadventitial microvascular flow, subcutaneous microvascular flow, and skeletal microvascular flow were not collected for the Outcome Measure. | Posted | up to 30 days |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Lean Healthy Subjects | "Lean" defined as (BMI ≥18 and ≤25) Perflutren Lipid Microsphere Injectable Suspension: 1.3 mL activated DEFINITY® diluted in 50 mL of preservative-free saline will be used |
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Early termination (not feasible with available equipment) leading to small number of subjects analyzed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Muredach P. Reilly, MBBCh, MSCE | Associate Dean for Clinical and Translational Research, College of Physicians and Surgeons | 212-305-9453 | mpr2144@cumc.columbia.edu |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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Obese grade I-II defined as (BMI>30 and ≤35)
Perflutren Lipid Microsphere Injectable Suspension: 1.3 mL activated DEFINITY® diluted in 50 mL of preservative-free saline will be used
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
Obese grade I-II defined as (BMI>30 and ≤35)
Perflutren Lipid Microsphere Injectable Suspension: 1.3 mL activated DEFINITY® diluted in 50 mL of preservative-free saline will be used
|
| Secondary | Microvascular Flow in the Periadventitial, Subcutaneous and Skeletal Muscle Tissues | Reliable data for periadventitial microvascular flow, subcutaneous microvascular flow, and skeletal muscle microvascular flow were not be collected for this outcome measure. | Posted | up to 30 days |
|
|
| 0 |
| 6 |
| 0 |
| 6 |
| 0 |
| 6 |
| EG001 | Obese Healthy Subjects | Obese grade I-II defined as (BMI>30 and ≤35) Perflutren Lipid Microsphere Injectable Suspension: 1.3 mL activated DEFINITY® diluted in 50 mL of preservative-free saline will be used | 0 | 0 | 0 | 0 | 0 | 0 |
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |