3-D Transcranial Ultrasound Analysis Study

NCT ID: NCT00239525

Last Updated: 2014-04-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-05-31

Study Completion Date

2013-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cerebrovascular Accident Intracranial Hypertension

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

3-D ultrasound scanner

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.

Intervention Type DEVICE

Perflutren Protein-Type A Microspheres for injection

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.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Definity

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Duke University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Daniel T Laskowitz, MD

Role: PRINCIPAL_INVESTIGATOR

Duke UMC

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Duke University Medical Center

Durham, North Carolina, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type RESULT
PMID: 21693401 (View on PubMed)

Ivancevich 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.

Reference Type RESULT
PMID: 18395321 (View on PubMed)

Smith 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.

Reference Type RESULT
PMID: 18947918 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Pro00008393

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

SHAPE for ICP Assessment
NCT06571786 COMPLETED PHASE2
tSCI Contrast Enhanced Ultrasound Study
NCT04056988 COMPLETED PHASE4
Blood Flow Restriction Concussion
NCT03695042 TERMINATED NA