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. ]

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.


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 ]

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.


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. ]

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.


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 ]

To assess 3 different dose levels of 0.15 mL, 0.5 mL and 1.5 mL of Optison in 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.


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