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

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ClinicalTrials.gov Identifier: NCT03028246
Recruitment Status : Recruiting
First Posted : January 23, 2017
Last Update Posted : May 24, 2019
Sponsor:
Information provided by (Responsible Party):
InSightec

Study Description
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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.


Condition or disease Intervention/treatment Phase
Benign Centrally-Located Intracranial Tumors Device: ExAblate 4000 System Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
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 : March 31, 2021
Estimated Study Completion Date : December 31, 2022
Arms and Interventions
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Arm Intervention/treatment
Experimental: ExAblate 4000 System
MR-Guided Focused Ultrasound
 Device: ExAblate 4000 System
Focused ultrasound
Other Names:
  • MRgFUS
  • HIFU
  • Focused Ultrasound
  • MR-Guided Focused Ultrasound
  • ExAblate Neuro System


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. Changes in the General Physical Exam [ Time Frame: Baseline through 12 Month Follow Up ]
    Any changes in physical examination performed by a physician.

  2. Changes in the Neurological Exam [ Time Frame: Baseline through 12 Month Follow Up ]
    Any changes in neurological examination performed by the neurologist/neurosurgeon.

  3. Confrontational Visual Field Testing [ Time Frame: Baseline through 3 Month Follow Up ]
    Changes in confrontational visual field testing performed by a physician

  4. 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

  5. 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


Eligibility Criteria
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Ages Eligible for Study:   8 Years to 22 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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United States, Florida
Miami Children's Research Institute - Nicklaus Children's Hospital Recruiting
Miami, Florida, United States, 33155
Contact: John Ragheb, MD    305-662-8386    john.ragheb2@nicklaushealth.org   
Contact: Abel Ortega, RN/BSN    786-624-3611    researchinstitute@mch.com   
Principal Investigator: John Ragheb, MD         
Sub-Investigator: Ian Miller, MD         
Sponsors and Collaborators
InSightec
Investigators
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Principal Investigator: John Ragheb, MD Miami Children's Research Institute - Nicklaus Children's Hospital
More Information
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Responsible Party: InSightec
ClinicalTrials.gov Identifier: NCT03028246     History of Changes
Other Study ID Numbers: BT005
First Posted: January 23, 2017    Key Record Dates
Last Update Posted: May 24, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Pediatric Postmarket Surveillance of a Device Product: No
Additional relevant MeSH terms:
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Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
 Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases