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: April 16, 2014
Last verified: April 2014
  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:
  • 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. ] [ Designated as safety issue: No ]
    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:
  • 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. ] [ Designated as safety issue: No ]
    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.


Enrollment: 21
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Results First Received: March 7, 2014
Last Updated: April 16, 2014
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
Brain Diseases
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Nervous System Diseases
Vascular Diseases
FS 069
Contrast Media
Diagnostic Uses of Chemicals
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 30, 2014