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

Carotid Artery Disease Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01394926
• Other study ID #: GE-191-001
• Status: Terminated
• Phase: Phase 2
• First received: July 13, 2011
• Last updated: April 16, 2014
• Start date: June 2011
• Est. completion date: June 2012

Study information

• Verified date: April 2014
• Source: GE Healthcare
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 21
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Carotid Artery Disease
• Carotid Artery Diseases

Intervention

Drug:
• Optison
Optison is a sterile non-pyrogenic suspension of perflutren for IV administration.

Locations

Country	Name	City	State
United States	GE Healthcare	Princeton	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
GE Healthcare

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Finding the Optimal Dose of Optison From 3 Different Dose Levels; 0.15mL, 0.5mL, and 1.5mL.	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.	Up to 10 minutes post contrast administration.	No
Secondary	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.	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.	Up to 10 minutes post contrast administration.	No