Clinical Trial: Dose-Finding, Feasibility Study of Optison in Contrast Enhanced U/S for the Detection of Carotid Artery Disease
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
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
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.
Detailed Summary:
Sponsor: GE Healthcare
Current Primary Outcome: Finding the Optimal Dose of Optison From 3 Different Dose Levels; 0.15mL, 0.5mL, and 1.5mL. [ Time Frame: Up to 10 minutes post contrast administration. ]
Original Primary Outcome: Assessing the presence of disease of the carotid arteries [ Time Frame: Time zero equals the date of contrast imaging (day 1) and for up to 60 minutes for safety monitoring post contrast administration ]
Current 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. [ Time Frame: Up to 10 minutes post contrast administration. ]
Original Secondary Outcome: Detecting the presence of stenosis [ Time Frame: Time zero equals the date of contrast imaging (day 1) and for up to 60 minutes for safety monitoring post contrast administration ]
Information By: GE Healthcare
Dates:
Date Received: July 13, 2011
Date Started: June 2011
Date Completion:
Last Updated: April 16, 2014
Last Verified: April 2014