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

NCT01394926 | Terminated Phase 2 Results

• 1 other identifier: GE-191-001
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Carotid Artery Disease

Keywords

CE-U/S - Contrast-Enhanced U/S; U/S - Ultrasound; Assess effectiveness

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (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.

  Up to 10 minutes post contrast administration.

Study Arms (1)

Arm Number 1

EXPERIMENTAL

Drug: Optison

Interventions

Optison DRUG

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

Also known as: Perflutren Protein-Type A Microspheres Injectable Suspension, USP

Arm Number 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GE Healthcare: lead

Study Sites (1)

GE Healthcare

Princeton, New Jersey, 08540, United States

Location

MeSH Terms

Conditions

Carotid Artery Diseases

Interventions

FS 069

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Paul Sherwin, M.D.
• Organization: GE Healthcare

Paulsherwin@ge.com

1-609-514-6820

Study Officials

• Andrea Perrone, M.D.

  GE Healthcare

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2011
• First Posted: July 15, 2011
• Study Start: June 1, 2011
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: May 2, 2014
• Results First Posted: April 16, 2014

Record last verified: 2014-04

Locations

US (1)