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Pre-clinical testing of a phased array ultrasound system for MRI-guided noninvasive surgery of the brain--a primate study.

Authors: Hynynen K, McDannold N, Clement G, Jolesz FA, Zadicario E, Killiany R, Moore T, Rosen D

MRI-guided and monitored focused ultrasound thermal surgery of brain through intact skull was tested in three rhesus monkeys. The aim of this study was to determine the amount of skull heating in an animal model with a head shape similar to that of a human. The ultrasound beam was generated by a 512 channel phased array system (Exablate 3000, InSightec, Haifa, Israel) that was integrated within a 1.5-T MR-scanner. The skin was pre-cooled by degassed temperature controlled water circulating between the array surface and the skin. Skull surface temperature was measured with invasive thermocouple probes. The results showed that by applying surface cooling the skin and skull surface can be protected, and that the brain surface temperature becomes the limiting factor. The MRI thermometry was shown to be useful in detecting the tissue temperature distribution next to the bone, and it should be used to monitor the brain surface temperature. The acoustic intensity values during the 20 s sonications were adequate for thermal ablation in the human brain provided that surface cooling is used.

Introduction

Purpose Thermal ablation
Study Objective To evaluate the safety and effectiveness of a phased-array ultrasound system for MRI-guided noninvasive brain surgery in a primate model.
Animal model / Human subject Primate (Rhesus Monkey), strain not specified, age not specified, sex not specified

Outcomes and Safety

Summary of Outcomes Reduced surface cooling skull heating during MRI-guided FUS, brain surface temperature was the primary safety-limiting factor for transcranial thermal ablation
Safety-related matter No safety or adverse effects are mentioned in the provided text.

Brain Region

Visualization unavailable

Ultrasound Parameters

Ultrasound instrument ExAblate 3000 (InSightex)
FUS Frequency 670 kHz
FUS Mode continuous
Duration of a single FUS session 20 s
Focal Characteristics Focal depth: None; Focal length: None; Aperture size: None
Treatment frequency multiple sessions

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