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Initial experience with magnetic resonance-guided focused ultrasound stereotactic surgery for central brain lesions in young adults.

Authors: Tierney TS, Alavian KN, Altman N, Bhatia S, Duchowny M, Hyslop A, Jayakar P, Resnick T, Wang S, Miller I, Ragheb J

Magnetic resonance-guided focused ultrasound (MRgFUS) is an incisionless procedure capable of thermoablation through the focus of multiple acoustic beams. Although MRgFUS is currently approved for the treatment of tremor in adults, its safety and feasibility profile for intracranial lesions in the pediatric and young adult population remains unknown. The long-term outcomes of a prospective single-center, single-arm trial of MRgFUS at Nicklaus Children's Hospital in Miami, Florida, are presented. Patients 15-22 years of age with centrally located lesions were recruited, clinically consistent with WHO grade I tumors that require surgical intervention. This cohort consisted of 4 patients with hypothalamic hamartoma (HH), and 1 patient with tuberous sclerosis complex harboring a subependymal giant cell astrocytoma (SEGA). In each case, high-intensity FUS was used to target the intracranial lesion. Real-time MRI was used to monitor the thermoablations. Primary outcomes of interest were tolerability, feasibility, and safety of FUS. The radiographic ablation volume on intra- and postoperative MRI was also assessed. All 5 patients tolerated the procedure without any complications. Successful thermoablation was achieved in 4 of the 5 cases; the calcified SEGA was undertreated due to intratumor calcification, which prevented attainment of the target ablation temperature. The HHs underwent target tissue thermoablations that led to MR signal changes at the treatment site. For the patients harboring HHs, FUS thermoablations occurred without procedure-related complications and led to improvement in seizure control or hypothalamic hyperphagia. All 5 patients were discharged home on postoperative day 1 or 2, without any readmissions. There were no cases of hemorrhage, electrolyte derangement, endocrinopathy, or new neurological deficit in this cohort. This experience demonstrates that FUS thermoablation of centrally located brain lesions in adolescents and young adults can be performed safely and that it provides therapeutic benefit for associated symptoms.

Introduction

Purpose Thermal ablation
Study Objective To report the initial experience evaluating the feasibility, safety, and preliminary outcomes of MRI-guided focused ultrasound stereotactic surgery for central brain lesions in young adults.
Animal model / Human subject Homo sapiens, N/A, young adults, 3 female, 2 male
Disease model Hypothalamic hamartoma (HH), subependymal giant cell astrocytoma (SEGA), tuberous sclerosis complex (TSC), epilepsy, hypothalamic obesity, precocious puberty, autism, developmental delay.
MRI or image guidance method Magnetic resonance-guided (MRI-guided) stereotactic
Targeted brain region(s) Hypothalamus

Outcomes and Safety

Summary of Outcomes MRgFUS is safe and feasible for treating deep intracranial benigh lesions in young adults aged 15-22 years; 4 patients with hypothalamic hamartoma achieved significant improvement in clinical symptoms after treatment, while 1 patient with calcified SEGA failed treatment due to inability to reach the target ablation temperature caused by intratumoral calcification; all patients had no serious complications and were discharged 1-2 days after surgery.
Duration of biological effect 13-43 months
Safety-related matter All 5 patients tolerated the surgery well without serious complications; no adverse events such as intracranial hemorrhage, electrolyte disturbance, endocrine abnormality, or new neurological deficit occurved; only 1 patient developed mild drug rash, which was cured by antihistamine drugs.

Brain Region

Ultrasound Parameters

Ultrasound instrument Insightex ExAblate 4000 FUS system
FUS Frequency 650 kHz
Focal Characteristics Focal depth: None; Focal length: None; Aperture size: None
Treatment frequency single session

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