DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

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


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.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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


Locations and Contacts

GE Healthcare, Princeton, New Jersey 08540, United States
Additional Information

Starting date: June 2011
Last updated: April 16, 2014

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017