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

November 1, 2023 updated by: InSightec

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

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.

Study Overview

Status

Recruiting

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • Recruiting
        • Children's National Medical Center
        • Principal Investigator:
          • Robert Keating
        • Sub-Investigator:
          • Roger Packer
        • Contact:
    • Florida
      • Miami, Florida, United States, 33155
        • Recruiting
        • Nicklaus Children's Hospital Insititute
        • Contact:
        • Contact:
        • Principal Investigator:
          • John Ragheb, MD
        • Sub-Investigator:
          • Ian Miller, MD
        • Sub-Investigator:
          • Luis Mendoza, MD
        • Sub-Investigator:
          • Toba Niazi, MD
        • Sub-Investigator:
          • Sanjiv Bhatia, MD
        • Sub-Investigator:
          • Pat Dean, ARNP
        • Sub-Investigator:
          • Ziad Khatib, MD
        • Sub-Investigator:
          • Ann Hsylop, MD
        • Sub-Investigator:
          • Nolan Altman, MD
        • Sub-Investigator:
          • Christian Bauer, MD
        • Sub-Investigator:
          • Frank Wang, MD
        • Sub-Investigator:
          • Paquine Sadeghi, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 22 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ExAblate 4000 System
MR-Guided Focused Ultrasound
Focused ultrasound
Other Names:
  • HIFU
  • Focused Ultrasound
  • MRgFUS
  • MR-Guided Focused Ultrasound
  • ExAblate Neuro System

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Treatment-Emergent Adverse Events Safety and Tolerability
Time Frame: Post ExAblate Procedure through 12 Month Follow-up
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
Time Frame: Baseline through 12 Month Follow Up
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
Time Frame: Baseline through 12 Month Follow Up
Any changes in physical examination performed by a physician.
Baseline through 12 Month Follow Up
Changes in the Neurological Exam
Time Frame: Baseline through 12 Month Follow Up
Any changes in neurological examination performed by the neurologist/neurosurgeon.
Baseline through 12 Month Follow Up
Confrontational Visual Field Testing
Time Frame: Baseline through 3 Month Follow Up
Changes in confrontational visual field testing performed by a physician
Baseline through 3 Month Follow Up
Global Impression of Change-Clinician
Time Frame: Day 1 through 12 Month Follow Up
Impression of change as the result of the treatment by a physician
Day 1 through 12 Month Follow Up
Patient Global Impression of Change
Time Frame: Day 1 through 12 Month Follow Up
Impression of change as the result of the treatment by the subject
Day 1 through 12 Month Follow Up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: John Ragheb, MD, Miami Children's Research Institute - Nicklaus Children's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 28, 2017

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

January 16, 2017

First Submitted That Met QC Criteria

January 18, 2017

First Posted (Estimated)

January 23, 2017

Study Record Updates

Last Update Posted (Actual)

November 2, 2023

Last Update Submitted That Met QC Criteria

November 1, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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