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

Phase 2

Terminated

• Conditions: Carotid Artery Disease
• Interventions: Drug: Optison

• Registration Number: NCT01394926
• Lead Sponsor: GE Healthcare

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 Description

Not available

Study Timeline

• Study Start: 2011-06
• Study First Submitted: 2011-07-13
• Study First Submitted QC: 2011-07-14
• Study First Posted: 2011-07-15
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Results First Submitted: 2014-03-07
• Results First Submitted QC: 2014-03-07
• Status Verified: 2014-04
• Results First Posted: 2014-04-16
• Last Update Submitted: 2014-04-16
• Last Update Posted: 2014-05-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 21

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm Number 1	Optison	-

Primary Outcome Measures

Name	Time	Method
Finding the Optimal Dose of Optison From 3 Different Dose Levels; 0.15mL, 0.5mL, and 1.5mL.	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.

Secondary Outcome Measures

Name	Time	Method
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.	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.

Trial Locations

Locations (1)

GE Healthcare; 🇺🇸 Princeton, New Jersey, United States