Neoplasms

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Hamartoma

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Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

ExAblate 4000 System

Sophie Kopec

Robert Keating

Roger Packer

The Focused Ultrasound Team

John Ragheb, MD

Ian Miller, MD

Luis Mendoza, MD

Toba Niazi, MD

Sanjiv Bhatia, MD

Pat Dean, ARNP

Ziad Khatib, MD

Ann Hsylop, MD

Nolan Altman, MD

Christian Bauer, MD

Frank Wang, MD

Paquine Sadeghi, MD

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.

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.

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

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

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.

ExAblate procedure will demonstrate feasibility along with measurement of tumor volumes at follow-up as compared to the baseline MRI.

Any changes in physical examination performed by a physician.

Any changes in neurological examination performed by the neurologist/neurosurgeon.

Changes in confrontational visual field testing performed by a physician

Impression of change as the result of the treatment by a physician

Impression of change as the result of the treatment by the subject

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Feasibility Safety Study of Benign Centrally-Located Intracranial Tumors in Pediatric and Young Adult Subjects	NCT03028246	Benign Centrall...	ExAblate 4000 S...	8 Years - 22 Years	InSightec
A Feasibility Safety Study of Benign Centrally-Located Intracranial Tumors in Pediatric and Young Adult Subjects	NCT03028246	Benign Centrall...	ExAblate 4000 S...	8 Years - 22 Years	InSightec
A Feasibility Safety Study of Benign Centrally-Located Intracranial Tumors in Pediatric and Young Adult Subjects	NCT03028246	Benign Centrall...	ExAblate 4000 S...	8 Years - 22 Years	InSightec

Spots Global Cancer Trial Database for hamartoma

Every month we try and update this database with for hamartoma cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for hamartoma

Every month we try and update this database with for hamartoma cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for hamartoma cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.