Back to resultsDose-Finding, Feasibility Study of Optison in Contrast Enhanced U/S for the Detection of Carotid Artery Disease
Primary Purpose
Carotid Artery Disease
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Optison
Sponsored by
About this trial
This is an interventional diagnostic trial for Carotid Artery Disease focused on measuring CE-U/S - Contrast-Enhanced U/S, U/S - Ultrasound, Assess effectiveness
Eligibility Criteria
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.
Sites / Locations
- GE Healthcare
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Arm Number 1
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01394926
Brief Title
Dose-Finding, Feasibility Study of Optison in Contrast Enhanced U/S for the Detection of Carotid Artery Disease
Official Title
A Multi-Center, Open-Label, Dose-Finding, Feasibility Study of Optison in Contrast Enhanced U/S for the Detection of Carotid Artery Disease
Study Type
Interventional
2. Study Status
Record Verification Date
April 2014
Overall Recruitment Status
Terminated
Why Stopped
Lack of Subject Recruitment
Study Start Date
June 2011 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GE Healthcare
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carotid Artery Disease
Keywords
CE-U/S - Contrast-Enhanced U/S, U/S - Ultrasound, Assess effectiveness
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm Number 1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Optison
Other Intervention Name(s)
Perflutren Protein-Type A Microspheres Injectable Suspension, USP
Intervention Description
Optison is a sterile non-pyrogenic suspension of perflutren for IV administration.
Primary Outcome Measure Information:
Title
Finding the Optimal Dose of Optison From 3 Different Dose Levels; 0.15mL, 0.5mL, and 1.5mL.
Description
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.
Time Frame
Up to 10 minutes post contrast administration.
Secondary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
Up to 10 minutes post contrast administration.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrea Perrone, M.D.
Organizational Affiliation
GE Healthcare
Official's Role
Study Director
Facility Information:
Facility Name
GE Healthcare
City
Princeton
State/Province
New Jersey
ZIP/Postal Code
08540
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Dose-Finding, Feasibility Study of Optison in Contrast Enhanced U/S for the Detection of Carotid Artery Disease
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