Cerebrovascular AccidentDefinityNCT00239525
3-D Transcranial Ultrasound Analysis Study
A study testing 3-D ultrasound scanner and Perflutren Protein-Type A Microspheres for injection in people with Cerebrovascular Accident and Intracranial Hypertension, run by Duke University at 1 site in United States.
Trial summary
The purpose of this study is to investigate real time 3-D ultrasound imaging of the brain for the diagnosis and evaluation of stroke. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Cerebrovascular Accident, Intracranial Hypertension
- What is being tested?
- 3-D ultrasound scanner and Perflutren Protein-Type A Microspheres for injection
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- May 2006to Dec 2013
- Phase
- Interventional
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- persons <18 years old
- pregnant or nursing women
- history of neurological disease
- congenital heart defect
- severe liver dysfunction
- respiratory distress syndrome
- hypersensitivity or an allergic reaction to blood products.
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
Official title: 3-D Transcranial Ultrasound Analysis Using Definity Injectable Suspension
The purpose of this study is to investigate real time 3-D ultrasound imaging of the brain for the diagnosis and evaluation of stroke.
Read the detailed description
The objective of this proposal is to extend our previous advances to investigate real time 3-D ultrasound imaging of the brain for the diagnosis and evaluation of stroke. Over the last decade, with the availability of color flow Doppler combined with effective ultrasound contrast agents, a renaissance has occurred in transcranial sonography as a low cost, bedside method for evaluation and management of patients with cerebrovascular disease in spite of the image degrading properties of the skull. Our hypothesis is that we can combine new generations of 2D array transducers with ultrasound contrast agents and phase aberration correction to enable real time 3D ultrasound imaging and 3D color flow Doppler of the brain with a factor of 10 improvement in spatial resolution compared to conventional transcranial sonography for improved diagnosis and evaluation of stroke.
- Being tested
- 3-D ultrasound scanner, Perflutren Protein-Type A Microspheres for injection
- Keywords
- Cerebrovascular Accident, Intracranial Hypertension
- Medical subject headings
- Stroke, Intracranial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3-D ultrasound scannerDevice
The availability of color flow Doppler combined with effective ultrasound contrast agents in transcranial sonography serves as a low cost, bedside method for evaluation and management of patients with cerebrovascular disease in spite of the image degrading properties of the skull.
Perflutren Protein-Type A Microspheres for injectionDrug
Also called Definity
Activated DEFINITY® (Perflutren Lipid Microsphere) Injectable Suspension is indicated for use in patients with suboptimal echocardiograms to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border.Bolus: The recommended dose for activated DEFINITY® is 10 microliters (μL)/kg of the activated product by intravenous bolus injection within 30-60 seconds, followed by a 10 mL saline flush. If necessary, a second 10 microliters (μL)/kg dose followed by a second 10 mL saline flush may be administered 30 minutes after the first injection to prolong contrast enhancement. Infusion: The recommended dose for activated DEFINITY® is via an IV infusion of 1.3 mL added to 50 mL of preservative-free saline. The rate of infusion should be initiated at 4.0 mL/minute, but titrated as necessary to achieve optimal image enhancement, not to exceed 10 mL/minute.
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase aberration correction of skull bone
This study will look to improve adaptive signal processing techniques for phase aberration correction of the skull while incorporating ultrasound contrast agent to increase signal to noise ratio in an ultrasound B-scan system with high speed RF data acquisition and 2-D arrays.In addition,we hope to develop adaptive transcranial real time 3D ultrasound and real time 3D color flow Doppler scanning of the brain incorporating ultrasound contrast agent to increase signal to noise ratio. A clinical evaluation of adaptive transcranial ultrasound imaging of the brain with phase aberration correction and ultrasound contrast agent will be conducted.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2005 (estimated)
- Study startMay 2006
- Primary completionApr 2007
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cerebrovascular AccidentStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniel T Laskowitz, MD, Principal investigator, Duke UMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00239525
- Sponsor's protocol ID
- Pro00008393
- Acronym
- Definity
- Status last verified
- Apr 2014
- First submitted
- 13 Oct 2005
- Last updated
- 11 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lindsey BD, Light ED, Nicoletto HA, Bennett ER, Laskowitz DT, Smith SW. The ultrasound brain helmet: new transducers and volume registration for in vivo simultaneous multi-transducer 3-D transcranial imaging. IEEE Trans Ultrason Ferroelectr Freq Control. 2011 Jun;58(6):1189-202. doi: 10.1109/TUFFC.2011.1929.
PubMed 21693401Ivancevich NM, Pinton GF, Nicoletto HA, Bennett E, Laskowitz DT, Smith SW. Real-time 3-D contrast-enhanced transcranial ultrasound and aberration correction. Ultrasound Med Biol. 2008 Sep;34(9):1387-95. doi: 10.1016/j.ultrasmedbio.2008.01.015. Epub 2008 Apr 18.
PubMed 18395321Smith SW, Ivancevich NM, Lindsey BD, Whitman J, Light E, Fronheiser M, Nicoletto HA, Laskowitz DT. The ultrasound brain helmet: feasibility study of multiple simultaneous 3D scans of cerebral vasculature. Ultrasound Med Biol. 2009 Feb;35(2):329-38. doi: 10.1016/j.ultrasmedbio.2008.08.016. Epub 2008 Oct 23.
PubMed 18947918
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 3-D Transcranial Ultrasound Analysis Using Definity Injectable Suspension
- ClinicalTrials.gov ID
- NCT00239525
- Acronym / sponsor ID
- Definity / Pro00008393
- Keywords
- Cerebrovascular Accident, Intracranial Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- May 2006
- Primary completion
- Apr 2007 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 17 Oct 2005 (estimated)
- 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 study is to investigate real time 3-D ultrasound imaging of the brain for the diagnosis and evaluation of stroke.
Detailed description
The objective of this proposal is to extend our previous advances to investigate real time 3-D ultrasound imaging of the brain for the diagnosis and evaluation of stroke. Over the last decade, with the availability of color flow Doppler combined with effective ultrasound contrast agents, a renaissance has occurred in transcranial sonography as a low cost, bedside method for evaluation and management of patients with cerebrovascular disease in spite of the image degrading properties of the skull. Our hypothesis is that we can combine new generations of 2D array transducers with ultrasound contrast agents and phase aberration correction to enable real time 3D ultrasound imaging and 3D color flow Doppler of the brain with a factor of 10 improvement in spatial resolution compared to conventional transcranial sonography for improved diagnosis and evaluation of stroke.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (7 listed)
- persons <18 years old
- pregnant or nursing women
- history of neurological disease
- congenital heart defect
- severe liver dysfunction
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 |
|---|---|---|
| 3-D ultrasound scannerThe availability of color flow Doppler combined with effective ultrasound contrast agents in transcranial sonography serves as a low cost, bedside method for evaluation and management of patients with cerebrovascular disease in spite of the image degrading properties of the skull. | Device | – |
| Perflutren Protein-Type A Microspheres for injectionAlso: DefinityActivated DEFINITY® (Perflutren Lipid Microsphere) Injectable Suspension is indicated for use in patients with suboptimal echocardiograms to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border.Bolus: The recommended dose for activated DEFINITY® is 10 microliters (μL)/kg of the activated product by intravenous bolus injection within 30-60 seconds, followed by a 10 mL saline flush. If necessary, a second 10 microliters (μL)/kg dose followed by a second 10 mL saline flush may be administered 30 minutes after the first injection to prolong contrast enhancement. Infusion: The recommended dose for activated DEFINITY® is via an IV infusion of 1.3 mL added to 50 mL of preservative-free saline. The rate of infusion should be initiated at 4.0 mL/minute, but titrated as necessary to achieve optimal image enhancement, not to exceed 10 mL/minute. | Drug | – |
Primary outcome
Phase aberration correction of skull bone
Time frame: 6 months
This study will look to improve adaptive signal processing techniques for phase aberration correction of the skull while incorporating ultrasound contrast agent to increase signal to noise ratio in an ultrasound B-scan system with high speed RF data acquisition and 2-D arrays.In addition,we hope to develop adaptive transcranial real time 3D ultrasound and real time 3D color flow Doppler scanning of the brain incorporating ultrasound contrast agent to increase signal to noise ratio. A clinical evaluation of adaptive transcranial ultrasound imaging of the brain with phase aberration correction and ultrasound contrast agent will be conducted.
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 11 Apr 2014.
- Results publication: PubMed 21693401Lindsey BD, Light ED, Nicoletto HA, Bennett ER, Laskowitz DT, Smith SW. The ultrasound brain helmet: new transducers and volume registration for in vivo simultaneous multi-transducer 3-D transcranial imaging. IEEE Trans Ultrason Ferroelectr Freq Control. 2011 Jun;58(6):1189-202. doi: 10.1109/TUFFC.2011.1929.
- Results publication: PubMed 18395321Ivancevich NM, Pinton GF, Nicoletto HA, Bennett E, Laskowitz DT, Smith SW. Real-time 3-D contrast-enhanced transcranial ultrasound and aberration correction. Ultrasound Med Biol. 2008 Sep;34(9):1387-95. doi: 10.1016/j.ultrasmedbio.2008.01.015. Epub 2008 Apr 18.
- Results publication: PubMed 18947918Smith SW, Ivancevich NM, Lindsey BD, Whitman J, Light E, Fronheiser M, Nicoletto HA, Laskowitz DT. The ultrasound brain helmet: feasibility study of multiple simultaneous 3D scans of cerebral vasculature. Ultrasound Med Biol. 2009 Feb;35(2):329-38. doi: 10.1016/j.ultrasmedbio.2008.08.016. Epub 2008 Oct 23.
Related trials for Cerebrovascular Accident
Recruiting
Connectomic Alterations Following Acute Ischemic Stroke in the MCA Territory
Ischemic Stroke
RecruitingObservational study
Clevidipine for the Antihypertensive Treatment of Acute Intracerebral Hemorrhage
Intracerebral Hemorrhage, Stroke
Active, not recruitingPhase 4
A Study Testing How Well the Drug Extract of Ginkgo Biloba Leaves Tablets Works for People With Memory or Thinking Problems After a Stroke When Added to Standard Treatment
Ischemic Stroke Hospitalized, Impairment, Cognitive
Not yet recruitingPhase 4
Anti-inflammatory and Anti-thrombotic Therapy With colcHicine and Low Dose Rivaroxaban for Major Adverse Cardiovascular Events Reduction in Ischemic Stroke
Ischemic Stroke
RecruitingObservational study
CoMind Early Feasibility Study
Intracranial Pressure, Intracranial Pressure Changes
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.
Daniel T Laskowitz, MD principal investigator
Duke UMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3-D ultrasound scanner and Perflutren Protein-Type A Microspheres for injection in people with Cerebrovascular Accident and Intracranial Hypertension, run by Duke University 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 0 inclusion and 7 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 11 Apr 2014. 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.
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?
Phase aberration correction of skull bone (time frame: 6 months). 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 NCT00239525, which also lists 3 linked publications.
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 11 Apr 2014.