Clinical trial NCT00239525: 3-D Transcranial Ultrasound Analysis Study
Official title: 3-D Transcranial Ultrasound Analysis Using Definity Injectable Suspension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebrovascular Accident
Intracranial Hypertension
Keywords: Cerebrovascular Accident
Intracranial Hypertension
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2005-10-17
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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.

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 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.

Primary outcomes:
measure: Phase aberration correction of skull bone
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke UMC
name: Daniel T Laskowitz, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.