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3-D Transcranial Ultrasound Analysis Study (Definity)

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Duke University

Status

Completed

Conditions

Cerebrovascular Accident
Intracranial Hypertension

Treatments

Device: 3-D ultrasound scanner
Drug: Perflutren Protein-Type A Microspheres for injection

Study type

Interventional

Funder types

Other

Identifiers

NCT00239525
Pro00008393

Details and patient eligibility

About

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

Full 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.

Enrollment

28 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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