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

This study has been terminated.
(Lack of Subject Recruitment)
Sponsor:
Information provided by (Responsible Party):
GE Healthcare
ClinicalTrials.gov Identifier:
NCT01394926
First received: July 13, 2011
Last updated: June 7, 2012
Last verified: June 2012
  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.


Condition Intervention Phase
Carotid Artery Disease
Drug: Optison
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by GE Healthcare:

Primary Outcome Measures:
  • 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 post contrast administration ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • 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 post contrast administration ] [ Designated as safety issue: No ]
    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/S by dose group.


Enrollment: 16
Study Start Date: June 2011
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01394926

Locations
United States, New Jersey
GE Healthcare
Princeton, New Jersey, United States, 08540
Sponsors and Collaborators
GE Healthcare
Investigators
Study Director: Andrea Perrone, M.D. GE Healthcare
  More Information

No publications provided

Responsible Party: GE Healthcare
ClinicalTrials.gov Identifier: NCT01394926     History of Changes
Other Study ID Numbers: GE-191-001
Study First Received: July 13, 2011
Last Updated: June 7, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by GE Healthcare:
CE-U/S - Contrast-Enhanced U/S
U/S - Ultrasound
Assess effectiveness

Additional relevant MeSH terms:
Carotid Artery Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 14, 2014