Dose-Finding, Feasibility Study of Optison in Contrast Enhanced U/S for the Detection of Carotid Artery Disease
Information source: GE Healthcare
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Carotid Artery Disease
Intervention: Optison (Drug)
Phase: Phase 2
Status: Terminated
Sponsored by: GE Healthcare Official(s) and/or principal investigator(s): Andrea Perrone, M.D., Study Director, Affiliation: GE Healthcare
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.
Clinical Details
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 design: Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Primary outcome: Finding the Optimal Dose of Optison From 3 Different Dose Levels; 0.15mL, 0.5mL, and 1.5mL.
Secondary outcome: 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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
GE Healthcare, Princeton, New Jersey 08540, United States
Additional Information
Starting date: June 2011
Last updated: April 16, 2014
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