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

• Sponsor: GE Healthcare (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT01394926
• Collaborator: (none)
• Enrollment: 21
• Location: 1
• Arm: 1
• Duration (Months): 12
• Patients Per Site Per Month: 1.7

Study Details

Study Description

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

• Study Type: Interventional
• 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: Jun 1, 2011
• Actual Primary Completion Date: Jun 1, 2012
• Actual Study Completion Date: Jun 1, 2012

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Finding the Optimal Dose of Optison From 3 Different Dose Levels; 0.15mL, 0.5mL, and 1.5mL. [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. [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

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	GE Healthcare	Princeton	New Jersey	United States	08540

Sponsors and Collaborators

• GE Healthcare

Investigators

• Study Director: Andrea Perrone, M.D., GE Healthcare

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: GE Healthcare
• ClinicalTrials.gov Identifier: NCT01394926
• Other Study ID Numbers: GE-191-001
• First Posted: Jul 15, 2011
• Last Update Posted: May 2, 2014
• Last Verified: Apr 1, 2014

• Keywords provided by GE Healthcare: CE-U/S - Contrast-Enhanced U/S; U/S - Ultrasound; Assess effectiveness
• Additional relevant MeSH terms: Carotid Artery Diseases

Study Results

Participant Flow

Recruitment Details	21 Subjects enrolled in study. 21 subjects completed this study. 0 subjects did not complete the study.

Arm/Group Title	Optison
Arm/Group Description	Optison is a sterile non-pyrogenic suspension of perflutren for IV administration.
Period Title: Overall Study
STARTED	21
COMPLETED	21
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Optison
Arm/Group Description	Optison is a sterile non-pyrogenic suspension of perflutren for IV administration.
Overall Participants	21
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	67.3 (9.40)
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	8 38.1%
>=65 years	13 61.9%
Sex: Female, Male (Count of Participants)
Female	11 52.4%
Male	10 47.6%
Region of Enrollment (participants) [Number]
United States	21 100%

Outcome Measures

1. Primary Outcome

Title	Finding the Optimal Dose of Optison From 3 Different Dose Levels; 0.15mL, 0.5mL, and 1.5mL.
Description	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.
Time Frame	Up to 10 minutes post contrast administration.

Outcome Measure Data

Analysis Population Description

Due to difficulty enrolling subjects in all three dose levels of Optison, this study was stopped prematurely. No efficacy analyses were performed.

Arm/Group Title	Dose Level 1: Injection of 0.15mL Optison at Time 0.	Dose Level 2: 0.5mL of Optsion at Time 6.5 Minutes	Dose Level 3: 1.5mL Optison 8 Minutes
Arm/Group Description	Dose Level 1 given as an Injection of 0.15mL of Optison at time 0.	Dose Level 2: Inj. of 0.5mL Optsion at time 6.5 minutes post dose level 1.	Dose Level 3: Injection of 1.5mL of Optison 8 minutes post level 2.
Measure Participants	0	0	0

2. Secondary Outcome

Title	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.
Description	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.
Time Frame	Up to 10 minutes post contrast administration.

Outcome Measure Data

Analysis Population Description

Due to difficulty enrolling subjects in all three dose levels of Optison , this study was stopped prematurely. No efficacy analyses were performed.

Arm/Group Title	Dose Level 1: Injection of 0.15mL Optison at Time 0.	Dose Level 2: 0.5mL Optison at Time 6.5 Minutes	Dose Level 3: 1.5mL Optison 8 Minutes
Arm/Group Description	Dose Level 1: Injection of 0.15mL Optison at time 0.	Dose Level 2: Injection given of 0.5mL of Optison at 6.5 minutes post dose level 1.	Dose Level 3: Injection of 1.5mL of Optison 8 minutes post dose level 2.
Measure Participants	0	0	0

Adverse Events

Arm/Group Title	Optison
Arm/Group Description	Optison is a sterile non-pyrogenic suspension of perflutren for IV administration.
All Cause Mortality
	Optison
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Optison
	Affected / at Risk (%)	# Events
Total	0/21 (0%)
Other (Not Including Serious) Adverse Events
	Optison
	Affected / at Risk (%)	# Events
Total	2/21 (9.5%)
Nervous system disorders
Dysgeusia	2/21 (9.5%)	2

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.