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

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.

Conditions

Benign Centrally-Located Intracranial Tumors

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Benign Centrally-Located Intracranial Tumors
Intervention / Treatment

-

Contacts and Locations

Washington

Children's National Medical Center, Washington, District of Columbia, United States, 20010

Miami

Nicklaus Children's Hospital Insititute, Miami, Florida, United States, 33155

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

8 Years to 22 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

InSightec,

John Ragheb, MD, PRINCIPAL_INVESTIGATOR, Miami Children's Research Institute - Nicklaus Children's Hospital

Study Record Dates

2024-12-31