Stroke, AcuteEarly Phase 1NCT03296852
Study: SONAS Ultrasound for Detecting Stroke SONAS Ultrasound for Detecting Stroke
A Early Phase 1 study testing SONAS Ultrasound Device and Lumason in people with Stroke, Acute, run by University of California, Los Angeles at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stroke, Acute
- What is being tested?
- SONAS Ultrasound Device and Lumason
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Apr 2018to 20 Jan 2019
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: SONAS Ultrasound Device for the Detection of Ischemic and Hemorrhagic Stroke
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.
Read the detailed description
Specific Aims: Indicate the purpose of the research, specifying the problems and/or hypotheses to be addressed.
Aim 1: Determine safety of the SONAS device Aim 1a: Obtain perfusion MRI (PWI) / quantitative MRI Aim 1b: Obtain MRI with gadolinium (gdMRI) Aim 2: Determine feasibility to detect microbubble specific frequencies
Research Design and Methods: Describe in detail the design and methodology of the study.
Since this is a 'first in human' study, testing primarily for the overall safety of the diagnostic approach, the aim is to enroll only healthy volunteers (e.g. no cerebro-/cardio-vascular history, no vascular risk factors etc.) into the study. We anticipate a total number of N=10 volunteers to be sufficient for this study.
Step 1 After written informed consent and prior to the SONAS ultrasound study each volunteer will undergo a baseline assessment in form of a physical exam, including vital signs, National Institute of Health Stroke Scale (NIHSS) assessment and Modified Ranking Scale as well as the assessment of the Medical History.
Step 2 Next, the volunteer will undergo a cranial MRI study. The MRI study will include a perfusion-weighted sequence to assess a baseline value for brain perfusion as well as gadolinium-enhanced T1-weighted images to assess the integrity of the blood-brain barrier.
Step 3
After the MRI study, the volunteer will undergo the SONAS ultrasound study. The study will be performed in supine position:
Two ultrasound transducers/probes will be positioned on both sides of the volunteer's head at the temporal bone (above and in front of the ear on each side). To hold the transducers/probes in place a customized headset has been designed which is easy to use and comforting for the proband.
Step 4 An IV line will be placed in a cubital or forearm vein. 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.
Step 5 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.
Step 6 Following the IV bolus injection of Lumason™, ultrasound will be transmitted and received signals acquired following the same protocol as detailed under Step 4.
Step 7 3 -5 hours after the SONAS ultrasound study has been performed Step 1 and Step 2 will be repeated.
- Conditions
- Stroke, Acute
- Being tested
- SONAS Ultrasound Device, Lumason
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SONAS Ultrasound DeviceDiagnostic 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.
LumasonDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Volunteers | Experimental | Not described Receives: Diagnostic Test: SONAS Ultrasound Device; Drug: Lumason |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2017
- Study start19 Apr 2018
- Primary completion26 Sep 2018
- Study completion20 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stroke, AcuteStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- Burl Concepts, Inc.
- Responsible party
- Principal investigator, David Liebeskind, University of California, Los Angeles
- Investigators
- David S Liebeskind, MD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03296852
- Sponsor's protocol ID
- 16-001538
- Status last verified
- Mar 2019
- First submitted
- 19 Sep 2017
- Last updated
- 26 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No: No plans to share any IPD with other researchers
Publications
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.
PubMed 35399083
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SONAS Ultrasound Device for the Detection of Ischemic and Hemorrhagic Stroke
- ClinicalTrials.gov ID
- NCT03296852
- Acronym / sponsor ID
- 16-001538
- Conditions
- Stroke, Acute
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- Burl Concepts, Inc.
- Study start
- 19 Apr 2018 (actual)
- Primary completion
- 26 Sep 2018 (actual)
- Study completion
- 20 Jan 2019 (actual)
- First posted
- 28 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Specific Aims: Indicate the purpose of the research, specifying the problems and/or hypotheses to be addressed.
Aim 1: Determine safety of the SONAS device Aim 1a: Obtain perfusion MRI (PWI) / quantitative MRI Aim 1b: Obtain MRI with gadolinium (gdMRI) Aim 2: Determine feasibility to detect microbubble specific frequencies
Research Design and Methods: Describe in detail the design and methodology of the study.
Since this is a 'first in human' study, testing primarily for the overall safety of the diagnostic approach, the aim is to enroll only healthy volunteers (e.g. no cerebro-/cardio-vascular history, no vascular risk factors etc.) into the study. We anticipate a total number of N=10 volunteers to be sufficient for this study.
Step 1 After written informed consent and prior to the SONAS ultrasound study each volunteer will undergo a baseline assessment in form of a physical exam, including vital signs, National Institute of Health Stroke Scale (NIHSS) assessment and Modified Ranking Scale as well as the assessment of the Medical History.
Step 2 Next, the volunteer will undergo a cranial MRI study. The MRI study will include a perfusion-weighted sequence to assess a baseline value for brain perfusion as well as gadolinium-enhanced T1-weighted images to assess the integrity of the blood-brain barrier.
Step 3
After the MRI study, the volunteer will undergo the SONAS ultrasound study. The study will be performed in supine position:
Two ultrasound transducers/probes will be positioned on both sides of the volunteer's head at the temporal bone (above and in front of the ear on each side). To hold the transducers/probes in place a customized headset has been designed which is easy to use and comforting for the proband.
Step 4 An IV line will be placed in a cubital or forearm vein. 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.
Step 5 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.
Step 6 Following the IV bolus injection of Lumason™, ultrasound will be transmitted and received signals acquired following the same protocol as detailed under Step 4.
Step 7 3 -5 hours after the SONAS ultrasound study has been performed Step 1 and Step 2 will be repeated.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteers | Experimental | Diagnostic Test: SONAS Ultrasound Device, Drug: Lumason |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SONAS Ultrasound DeviceTo 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. | Diagnostic test | Healthy Volunteers |
| LumasonAn 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. | Drug | Healthy Volunteers |
Primary outcome
Blood brain barrier impairment by extravasation of Gadolinium into the brain tissue
Time frame: 5 hours
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2019.
- Derived from this study: PubMed 35399083Kilic 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.
- Individual participant dataSharing planned: No. No plans to share any IPD with other researchers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David S Liebeskind, MD principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing SONAS Ultrasound Device and Lumason in people with Stroke, Acute, run by University of California, Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood brain barrier impairment by extravasation of Gadolinium into the brain tissue (time frame: 5 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03296852, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2019.