A Feasibility Safety Study of Benign Centrally-Located Intracranial Tumors in Pediatric and Young Adult Subjects

Study Overview
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Brief Summary
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The goal of this prospective, non-randomized, single-arm, feasibility study is to develop data to evaluate the safety and feasibility of ExAblate 4000 treatment of benign intracranial tumors which require clinical intervention in pediatric and young adult subjects. Indication of Use: Ablation of benign intracranial tumors in children and young adults which are ExAblate accessible.

Detailed Description
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The goal of this prospective, non-randomized, single-arm, feasibility study is to develop data to evaluate the safety and feasibility of ExAblate 4000 treatment of benign intracranial tumors which require clinical intervention in pediatric and young adult subjects. Indication of Use: Ablation of benign intracranial tumors in children and young adults which are ExAblate accessible. This is a feasibility study intended to collect data for use in the development of future studies. As such, no formal statistical hypothesis or hypothesis testing is proposed. The purpose of this study is to evaluate the safety and feasibility of managing benign brain tumor size using ExAblate 4000 treatment of progressing benign intracranial tumors which require clinical intervention in pediatric and young adult subjects.

Official Title
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A Feasibility Safety Study Using the ExAblate 4000 System in the Management of Benign Centrally-Located Intracranial Tumors Which Require Clinical Intervention in Pediatric and Young Adult Subjects

Conditions
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Benign Centrally-Located Intracranial Tumors

Intervention / Treatment
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* Device: ExAblate 4000 System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects with benign (WHO grade I) centrally located intracranial tumors which require clinical intervention and are known to carry minimal hemorrhage risk Minimum head circumference will be 52cm Subjects should be on a stable dose of all condition-related medications for 30 days prior to study entry as determine by medical records Exclusion Criteria: Subjects who are taking human growth hormone (hGH), also known as somatotropin Subjects with standard contraindications for MR imaging such as non-MRI compatible implanted metallic devices including vagus nerve stimulator, responsive neurostimulator, cardiac pacemakers, non-metallic shunts, size limitations, etc. Subjects with suicidal ideation or previous suicide attempt within the past year Subjects with malignant brain tumors, or the presence of any ambiguous clinical features that could imply a malignant potential to the tumor, or for which a biopsy is necessary Subjects for whom histopathology is important for ongoing management Subjects who are unwilling or unable to undergo general anesthesia

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 22 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ExAblate 4000 System<br>MR-Guided Focused Ultrasound | Device: ExAblate 4000 System<br>* Focused ultrasound<br>* Other names: ExAblate Neuro System;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Treatment-Emergent Adverse Events Safety and Tolerability | Safety will be assessed by tabulation of treatment related adverse events. All adverse events at least possibly procedure related will also be examined in detail for patterns of occurrence. | Post ExAblate Procedure through 12 Month Follow-up | 
| Measurement of Tumor Volume | ExAblate procedure will demonstrate feasibility along with measurement of tumor volumes at follow-up as compared to the baseline MRI. | Baseline through 12 Month Follow Up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in the General Physical Exam | Any changes in physical examination performed by a physician. | Baseline through 12 Month Follow Up | 
| Changes in the Neurological Exam | Any changes in neurological examination performed by the neurologist/neurosurgeon. | Baseline through 12 Month Follow Up | 
| Confrontational Visual Field Testing | Changes in confrontational visual field testing performed by a physician | Baseline through 3 Month Follow Up | 
| Global Impression of Change-Clinician | Impression of change as the result of the treatment by a physician | Day 1 through 12 Month Follow Up | 
| Patient Global Impression of Change | Impression of change as the result of the treatment by the subject | Day 1 through 12 Month Follow Up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hamartoma, Hypothalamic Hamartoma