RECRUITING

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

Talk to us

Conditions

Benign Centrally-Located Intracranial TumorsHamartomaHypothalamic Hamartoma

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

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

Quick Facts

Study Start:2017-02-28
Study Completion:2024-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03028246

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.

Ages Eligible for Study:8 Years to 22 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * Subjects with benign (WHO grade I) centrally located intracranial tumors which require clinical intervention and are known to carry minimal hemorrhage risk
  2. * Minimum head circumference will be 52cm
  3. * Subjects should be on a stable dose of all condition-related medications for 30 days prior to study entry as determine by medical records
  1. * Subjects who are taking human growth hormone (hGH), also known as somatotropin
  2. * 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.
  3. * Subjects with suicidal ideation or previous suicide attempt within the past year
  4. * 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
  5. * Subjects for whom histopathology is important for ongoing management
  6. * Subjects who are unwilling or unable to undergo general anesthesia

Contacts and Locations

Principal Investigator

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

Study Locations (Sites)

Children's National Medical Center
Washington, District of Columbia, 20010
United States
Nicklaus Children's Hospital Insititute
Miami, Florida, 33155
United States

Collaborators and Investigators

Sponsor: InSightec

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2017-02-28
Study Completion Date2024-12-31

Study Record Updates

Study Start Date2017-02-28
Study Completion Date2024-12-31

Terms related to this study

Keywords Provided by Researchers

  • Hamartoma
  • Hypothalamic Hamartoma

Additional Relevant MeSH Terms

  • Benign Centrally-Located Intracranial Tumors