3-D Transcranial Ultrasound Analysis Study (Definity)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00239525
First received: October 13, 2005
Last updated: April 9, 2014
Last verified: April 2014
  Purpose

The purpose of this study is to investigate real time 3-D ultrasound imaging of the brain for the diagnosis and evaluation of stroke.


Condition Intervention
Cerebrovascular Accident
Intracranial Hypertension
Device: 3-D ultrasound scanner
Drug: Perflutren Protein-Type A Microspheres for injection

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: 3-D Transcranial Ultrasound Analysis Using Definity Injectable Suspension

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • Phase aberration correction of skull bone [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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.


Enrollment: 28
Study Start Date: May 2006
Study Completion Date: December 2013
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: 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.
    Drug: 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.
    Other Name: Definity
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00239525

Locations
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
Investigators
Principal Investigator: Daniel T Laskowitz, MD Duke UMC
  More Information

Publications:
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00239525     History of Changes
Other Study ID Numbers: Pro00008393
Study First Received: October 13, 2005
Last Updated: April 9, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Duke University:
Cerebrovascular Accident
Intracranial Hypertension

Additional relevant MeSH terms:
Hypertension
Cerebral Infarction
Stroke
Intracranial Hypertension
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Definity
Perflutren
Contrast Media
Diagnostic Uses of Chemicals
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 16, 2014