search
Back to results

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

Primary Purpose

Benign Centrally-Located Intracranial Tumors

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ExAblate 4000 System
Sponsored by
InSightec
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Benign Centrally-Located Intracranial Tumors focused on measuring Hamartoma, Hypothalamic Hamartoma

Eligibility Criteria

8 Years - 22 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Children's National Medical CenterRecruiting
  • Nicklaus Children's Hospital InsitituteRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ExAblate 4000 System

Arm Description

MR-Guided Focused Ultrasound

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Changes in the General Physical Exam
Any changes in physical examination performed by a physician.
Changes in the Neurological Exam
Any changes in neurological examination performed by the neurologist/neurosurgeon.
Confrontational Visual Field Testing
Changes in confrontational visual field testing performed by a physician
Global Impression of Change-Clinician
Impression of change as the result of the treatment by a physician
Patient Global Impression of Change
Impression of change as the result of the treatment by the subject

Full Information

First Posted
January 16, 2017
Last Updated
August 16, 2022
Sponsor
InSightec
search

1. Study Identification

Unique Protocol Identification Number
NCT03028246
Brief Title
A Feasibility Safety Study of Benign Centrally-Located Intracranial Tumors in Pediatric and Young Adult Subjects
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 28, 2017 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
InSightec

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Benign Centrally-Located Intracranial Tumors
Keywords
Hamartoma, Hypothalamic Hamartoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ExAblate 4000 System
Arm Type
Experimental
Arm Description
MR-Guided Focused Ultrasound
Intervention Type
Device
Intervention Name(s)
ExAblate 4000 System
Other Intervention Name(s)
MRgFUS, HIFU, Focused Ultrasound, MR-Guided Focused Ultrasound, ExAblate Neuro System
Intervention Description
Focused ultrasound
Primary Outcome Measure Information:
Title
Incidence of Treatment-Emergent Adverse Events Safety and Tolerability
Description
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.
Time Frame
Post ExAblate Procedure through 12 Month Follow-up
Title
Measurement of Tumor Volume
Description
ExAblate procedure will demonstrate feasibility along with measurement of tumor volumes at follow-up as compared to the baseline MRI.
Time Frame
Baseline through 12 Month Follow Up
Secondary Outcome Measure Information:
Title
Changes in the General Physical Exam
Description
Any changes in physical examination performed by a physician.
Time Frame
Baseline through 12 Month Follow Up
Title
Changes in the Neurological Exam
Description
Any changes in neurological examination performed by the neurologist/neurosurgeon.
Time Frame
Baseline through 12 Month Follow Up
Title
Confrontational Visual Field Testing
Description
Changes in confrontational visual field testing performed by a physician
Time Frame
Baseline through 3 Month Follow Up
Title
Global Impression of Change-Clinician
Description
Impression of change as the result of the treatment by a physician
Time Frame
Day 1 through 12 Month Follow Up
Title
Patient Global Impression of Change
Description
Impression of change as the result of the treatment by the subject
Time Frame
Day 1 through 12 Month Follow Up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Ragheb, MD
Organizational Affiliation
Miami Children's Research Institute - Nicklaus Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's National Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sophie Kopec
Phone
202-476-5016
Email
skopec@childrensnational.org
First Name & Middle Initial & Last Name & Degree
Robert Keating
First Name & Middle Initial & Last Name & Degree
Roger Packer
Facility Name
Nicklaus Children's Hospital Insititute
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
The Focused Ultrasound Team
Phone
305-662-8386
Email
mrguidedfus@Nicklaushealth.org
First Name & Middle Initial & Last Name & Degree
John Ragheb, MD
Phone
305-662-8386
Email
john.ragheb2@nicklaushealth.org
First Name & Middle Initial & Last Name & Degree
John Ragheb, MD
First Name & Middle Initial & Last Name & Degree
Ian Miller, MD
First Name & Middle Initial & Last Name & Degree
Luis Mendoza, MD
First Name & Middle Initial & Last Name & Degree
Toba Niazi, MD
First Name & Middle Initial & Last Name & Degree
Sanjiv Bhatia, MD
First Name & Middle Initial & Last Name & Degree
Pat Dean, ARNP
First Name & Middle Initial & Last Name & Degree
Ziad Khatib, MD
First Name & Middle Initial & Last Name & Degree
Ann Hsylop, MD
First Name & Middle Initial & Last Name & Degree
Nolan Altman, MD
First Name & Middle Initial & Last Name & Degree
Christian Bauer, MD
First Name & Middle Initial & Last Name & Degree
Frank Wang, MD
First Name & Middle Initial & Last Name & Degree
Paquine Sadeghi, MD

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

We'll reach out to this number within 24 hrs