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

NCT03296852 | Completed Early Phase 1 FDA Drug FDA Device

• 1 other identifier: 16-001538
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research study is to test a new medical device, called SONAS. The SONAS device is a portable, battery-powered ultrasound device to detect strokes in the prehospital environment, such as emergency vehicles (eg. ambulances, helicopters). To demonstrate the safety of the device the goal is test it in a small number of healthy volunteers first. The SONAS device will be used to detect changes in blood flow to the brain through ultrasound, otherwise known as TransCranial Doppler (TCD). To date, the SONAS device has been tested extensively in the laboratory, in animals and in human cadavers. The purpose of the present study is to test the device for safety and efficacy in a small group of healthy volunteers. This study will test the device on 10 healthy volunteers. Each volunteer will have a physical examination, neurological examination, and brain MRI both before and after the TCD test is performed. All of these study procedures will be performed on 1 visit, lasting approximately 5 hours. The brain MRI's will be used to verify the effectiveness of the SONAS device on detecting changes in blood flow to the brain.

Conditions

Stroke, Acute

Outcome Measures

Primary Outcomes (1)

• Blood brain barrier impairment by extravasation of Gadolinium into the brain tissue

  BBB impairment will be assessed by extravasation of Gadolinium into the brain tissue. Because of its molecular weight Gadolinium cannot enter the extravascular space, unless the BBB integrity is impaired. BBB impairment causes leakage of Gadolinium in into the extravascular space which, in turn, can be visualized by T1-weighted sequences.

  5 hours

Study Arms (1)

Healthy Volunteers

EXPERIMENTAL

Diagnostic Test: SONAS Ultrasound Device; Drug: Lumason

Interventions

SONAS Ultrasound Device DIAGNOSTIC_TEST

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.

Healthy Volunteers

Lumason DRUG

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.

Healthy Volunteers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be at least 18 years of age
• No prior history of cerebro- or cardio-vascular disease
• Be willing to comply with study protocol
• Provide written informed consent

You may not qualify if:

• Lumason™ is contraindicated in subjects known to have right-to-left shunts, severe pulmonary hypertension (pulmonary artery pressure \>90 mmHg), uncontrolled systemic hypertension, and in subjects with adult respiratory distress syndrome.
• Lumason™ should not be used in combination with dobutamine in subjects with conditions suggesting cardiovascular instability where dobutamine is contraindicated.
• Lumason™ should not be used in subjects with known hypersensitivity to the following substances:
• Macrogol 4000
• Distearoylphosphatidylcholine
• Dipalmitoylphosphatidylglycerol
• Sodium Palmitic acid
• Female who is pregnant or a nursing mother (the possibility of pregnancy has to be excluded by negative serum or urine HCG results, obtained within 24 hours before Lumason™ administration, or on the basis patient history, e.g.: tubal ligation, hysterectomy, or a minimum of 1 year history without menses
• Contraindications to MRI, pregnancy, lactation, morbid obesity, and severe claustrophobia
• Known allergy to gadolinium

Sponsors & Collaborators

• University of California, Los Angeles: lead
• Burl Concepts, Inc.: collaborator

Study Sites (1)

UCLA Medical Center

Los Angeles, California, 90095, United States

Location

Related Publications (1)

• Kilic M, Scalzo F, Lyle C, Baldaranov D, Dirnbacher M, Honda T, Liebeskind DS, Schlachetzki F. A mobile battery-powered brain perfusion ultrasound (BPU) device designed for prehospital stroke diagnosis: correlation to perfusion MRI in healthy volunteers. Neurol Res Pract. 2022 Apr 11;4(1):13. doi: 10.1186/s42466-022-00179-8.

  PMID: 35399083 DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

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

Study Officials

• David S Liebeskind, MD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Neurology

Study Record Dates

• First Submitted: September 19, 2017
• First Posted: September 28, 2017
• Study Start: April 19, 2018
• Primary Completion: September 26, 2018
• Study Completion: January 20, 2019
• Last Updated: March 26, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)