A Feasibility Safety Study of Benign Centrally-Located Intracranial Tumors in Pediatric and Young Adult Subjects
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03028246 |
Recruitment Status :
Recruiting
First Posted : January 23, 2017
Last Update Posted : February 4, 2021
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Benign Centrally-Located Intracranial Tumors | Device: ExAblate 4000 System | Not Applicable |
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 (Clinical Trial) |
Estimated Enrollment : | 10 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 |
Actual Study Start Date : | February 28, 2017 |
Estimated Primary Completion Date : | December 31, 2022 |
Estimated Study Completion Date : | December 31, 2023 |
Arm | Intervention/treatment |
---|---|
Experimental: ExAblate 4000 System
MR-Guided Focused Ultrasound
|
Device: ExAblate 4000 System
Focused ultrasound
Other Names:
|
- 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.
- 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.
- Changes in the General Physical Exam [ Time Frame: Baseline through 12 Month Follow Up ]Any changes in physical examination performed by a physician.
- Changes in the Neurological Exam [ Time Frame: Baseline through 12 Month Follow Up ]Any changes in neurological examination performed by the neurologist/neurosurgeon.
- Confrontational Visual Field Testing [ Time Frame: Baseline through 3 Month Follow Up ]Changes in confrontational visual field testing performed by a physician
- 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
- 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 8 Years to 22 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03028246
United States, Florida | |
Nicklaus Children's Hospital Insititute | Recruiting |
Miami, Florida, United States, 33155 | |
Contact: John Ragheb, MD 305-662-8386 john.ragheb2@nicklaushealth.org | |
Contact: Leisa Tamayo 786-502-6122 leisa.tamayonenninger@nicklaushealth.org | |
Principal Investigator: John Ragheb, MD | |
Sub-Investigator: Shelly Wang, MD | |
Sub-Investigator: Marytery Fajardo, MD |
Principal Investigator: | John Ragheb, MD | Miami Children's Research Institute - Nicklaus Children's Hospital |
Responsible Party: | InSightec |
ClinicalTrials.gov Identifier: | NCT03028246 |
Other Study ID Numbers: |
BT005 |
First Posted: | January 23, 2017 Key Record Dates |
Last Update Posted: | February 4, 2021 |
Last Verified: | February 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
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 |
Hamartoma Hypothalamic Hamartoma |
Brain Neoplasms Central Nervous System Neoplasms Nervous System Neoplasms Neoplasms by Site |
Neoplasms Brain Diseases Central Nervous System Diseases Nervous System Diseases |