Study: SONAS Ultrasound for Detecting Stroke SONAS Ultrasound for Detecting Stroke

EARLY_PHASE1CompletedINTERVENTIONAL
Enrollment

12

Participants

Timeline

Start Date

April 19, 2018

Primary Completion Date

September 26, 2018

Study Completion Date

January 20, 2019

Conditions
Stroke, Acute
Interventions
DIAGNOSTIC_TEST

SONAS Ultrasound Device

To assess a baseline value, ultrasound will be transmitted following an automated protocol to increase subsequently the output voltage from 5 volts to 50 volts. At each voltage step the received signals will be acquired and stored. Once the maximum output voltage of 50 Volts has been reached an additional 10 ultrasound pulses will be transmitted and the received data acquired. The total duration of this first data acquisition is 20 seconds. Following the IV bolus injection of Lumason™, ultrasound will be transmitted and received signals acquired following the same protocol as before.

DRUG

Lumason

An IV line will be placed in a cubital or forearm vein. A bolus of 1.0ml of the ultrasound contrast agent (so called 'Microbubbles') Lumason™, internationally known as SonoVue (Bracco Pharmaceuticals, Italy), will be injected into the IV line, followed by a 5.0ml IV bolus injection of saline. Lumason™ has been FDA approved for cardiac applications to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border. In the context of the present study Lumason™ would be used off-label.

Trial Locations (1)

90095

UCLA Medical Center, Los Angeles

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Burl Concepts, Inc.

INDUSTRY

lead

University of California, Los Angeles

OTHER

NCT03296852 - Study: SONAS Ultrasound for Detecting Stroke SONAS Ultrasound for Detecting Stroke | Biotech Hunter | Biotech Hunter