- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03028246
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
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
Conditions
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
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
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:
- Sophie Kopec
- Phone Number: 202-476-5016
- Email: skopec@childrensnational.org
-
-
Florida
-
Miami, Florida, United States, 33155
- Recruiting
- Nicklaus Children's Hospital Insititute
-
Contact:
- The Focused Ultrasound Team
- Phone Number: 305-662-8386
- Email: mrguidedfus@Nicklaushealth.org
-
Contact:
- John Ragheb, MD
- Phone Number: 305-662-8386
- Email: john.ragheb2@nicklaushealth.org
-
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
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
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
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:
|
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
Sponsor
Investigators
- Principal Investigator: John Ragheb, MD, Miami Children's Research Institute - Nicklaus Children's Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- BT005
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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