Expired Study
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Princeton, New Jersey 08540


Purpose:

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.


Criteria:

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 is Available At:


Original ID:

GE-191-001


NCT ID:

NCT01394926


Secondary ID:


Study Acronym:


Brief Title:

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


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


Overall Status:

Terminated


Study Phase:

Phase 2


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

GE Healthcare


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:

Lack of Subject Recruitment


Study Type:

Interventional


Study Design:

Allocation: Non-Randomized, Intervention Model:


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

16


Enrollment Type:

Actual


Overall Contact Information

Official Name:Andrea Perrone, M.D.
Study Director
GE Healthcare

Study Dates

Start Date:June 2011
Completion Date:June 2012
Completion Type:Actual
Primary Completion Date:June 2012
Primary Completion Type:Actual
Verification Date:June 2012
Last Changed Date:June 7, 2012
First Received Date:July 13, 2011

Study Outcomes

Outcome Type:Secondary Outcome
Measure: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
Safety Issues:False
Description: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/
Outcome Type:Primary Outcome
Measure: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
Safety Issues:False
Description: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.

Study Interventions

Intervention Type:Drug
Name:Optison
Description:Optison is a sterile non-pyrogenic suspension of perflutren for IV administration.
Arm Name:Arm Number 1
Other Name:Perflutren Protein-Type A Microspheres Injectable

Study Arms

Study Arm Type:Experimental
Arm Name:Arm Number 1

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:GE Healthcare

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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