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

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ClinicalTrials.gov Identifier: NCT01394926
Recruitment Status : Terminated (Lack of Subject Recruitment)
First Posted : July 15, 2011
Results First Posted : April 16, 2014
Last Update Posted : May 2, 2014
Sponsor:
Information provided by (Responsible Party):
GE Healthcare

Study Description
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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.

Condition or disease Intervention/treatment Phase
Carotid Artery Disease Drug: Optison Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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 Start Date : June 2011
Actual Primary Completion Date : June 2012
Actual Study Completion Date : June 2012

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Arm Number 1 Drug: Optison
Optison is a sterile non-pyrogenic suspension of perflutren for IV administration.
Other Name: Perflutren Protein-Type A Microspheres Injectable Suspension, USP


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01394926


Locations
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United States, New Jersey
GE Healthcare
Princeton, New Jersey, United States, 08540
Sponsors and Collaborators
GE Healthcare
Investigators
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Study Director: Andrea Perrone, M.D. GE Healthcare
More Information
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Responsible Party: GE Healthcare
ClinicalTrials.gov Identifier: NCT01394926    
Other Study ID Numbers: GE-191-001
First Posted: July 15, 2011    Key Record Dates
Results First Posted: April 16, 2014
Last Update Posted: May 2, 2014
Last Verified: April 2014
Keywords provided by GE Healthcare:
CE-U/S - Contrast-Enhanced U/S
U/S - Ultrasound
Assess effectiveness
Additional relevant MeSH terms:
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Carotid Artery Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases