Dose-Finding, Feasibility Study of Optison in Contrast Enhanced U/S for the Detection of Carotid Artery Disease

Study Overview
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Brief Summary
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The purpose of this study is to find the optimal dose from 3 different dose levels - 0.15 mL, 0.5 mL and 1.5 mL of Optison in assessing the presence of disease of the carotid arteries when comparing pre-contrast to post-contrast ultrasound (U/S) by dose group.

Official Title
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A Multi-Center, Open-Label, Dose-Finding, Feasibility Study of Optison in Contrast Enhanced U/S for the Detection of Carotid Artery Disease

Conditions
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Carotid Artery Disease

Intervention / Treatment
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* Drug: Optison


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The subject is is greater than or equal to 18 years of age. The subjects has highly suspected or established carotid artery disease. The subject has undergone or been referred for either unilateral or bilateral intra-arterial X-ray carotid angiography for the determination of subject management (within 30 days before or after the U/S procedure). The subject has non-diagnostic U/S of the carotids as defined by institutional standards. Exclusion Criteria: The subject presents any clinically active, serious, life-threatening disease, with a life expectancy of less than 1 month or where study participation may compromise the management of the subject or other reason that in the judgment of the investigator makes the subject unsuitable for participation in the study. The subject has a history of acute occlusion requiring medical intervention of any artery (including aorta) within 6 months of consent. The subject has a known or suspected hypersensitivity to any of the components of Optison, blood, blood products, or albumin. The subject has right to left, bi-directional or transient right to left cardiac shunts.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm Number 1<br> | Drug: Optison<br>* Optison is a sterile non-pyrogenic suspension of perflutren for IV administration.<br>* Other names: Perflutren Protein-Type A Microspheres Injectable Suspension, USP;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Finding the Optimal Dose of Optison From 3 Different Dose Levels; 0.15mL, 0.5mL, and 1.5mL. | Assessing the presence of disease of the carotid arteries when comparing pre-contrast to post-contrast ultrasound (U/S) by dose group. Using the optimal dose from 3 different dose levels - 0.15 mL, 0.5 mL and 1.5 mL of Optison. | Up to 10 minutes post contrast administration. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detecting the Presence of Greater Than or Equal to 50% Stenosis and Greater Than or Equal to 75% Stenosis in the Carotid Arteries When Comparing Pre-contrast to Post-contrast Ultrasound by Dose Group. | Detecting the presence of greater than or equal to 50% stenosis and greater than or equal to 75% stenosis in the carotid arteries when comparing pre contrast to post-contrast U/S by dose group.Using the 3 different dose levels of 0.15 mL, 0.5 mL and 1.5 mL of Optison. | Up to 10 minutes post contrast administration. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CE-U/S - Contrast-Enhanced U/S, U/S - Ultrasound, Assess effectiveness