Recruiting

Observational Study

Sponsor:

InSightec

Code:

NCT03028246

Conditions

Benign Centrally-Located Intracranial Tumors

Eligibility Criteria

Sex: All

Age: 5 - 22

Healthy Volunteers: Not accepted

Interventions

ExAblate 4000 System

Study Details

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.

Conditions

Benign Centrally-Located Intracranial Tumors

Study ID

NCT03028246

Start date

Feb 28, 2017

Status verified date

May, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 5 - 22

Healthy Volunteers: Not accepted

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 49cm
  • Skull Density Ratio (SDR) should be ≥0.35
  • 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 and/or parent(s)/legal representative can provide accurate seizure diary log for the 30 days prior to FUS treatment and for the duration of the study

Exclusion Criteria:

  • Subjects with unstable cardiac status that would increase anesthetic risk including
  • Subjects exhibiting any behavior(s) consistent with ethanol or substance abuse as defined by the criteria outlined in the DSM-IV
  • 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.
  • Known intolerance or allergies to the MRI contrast agent (e.g. Gadolinium or Magnevist) or sedative medications
  • Severely impaired renal function (estimated glomerular filtration rate <70% of normal GFR for age) or receiving dialysis
  • Any history of clinically significant abnormal bleeding and/or coagulopathy
  • Receiving anticoagulant (e.g. warfarin) or antiplatelet (e.g. aspirin, NSAIDs) therapy within one week of focused ultrasound procedure or drugs known to increase risk or hemorrhage (e.g. Avastin) within one month of focused ultrasound procedure; or, unable or unwilling to stop anticoagulant for the purpose of focused ultrasound procedure
  • Use of valproate derivatives for seizure control within the preceding 2 weeks
  • Known or suspected acute, active, or uncontrolled infection
  • History of postnatal stroke or intracranial hemorrhage within 6 months
  • Clinical suspicion of increased intracranial pressure (as evidenced by symptoms of obstruction: headache, nausea, vomiting, lethargy, and papilledema)
  • Have participated in another interventional trial in the last 30 days
  • History of immunocompromise, including subject who is HIV positive with incomplete viral suppression
  • Known life-threatening systemic disease
  • 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
  • Female subjects who are pregnant, breast feeding or planning to become pregnant during the study or are unwilling to practice birth control during participation in the study, if of child-bearing age

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: ExAblate 4000 System

MR-Guided Focused Ultrasound

Interventions

ExAblate 4000 System

Focused ultrasound

Primary outcome measure

  • Incidence of Treatment-Emergent Adverse Events Safety and Tolerability [ Time Frame: Post ExAblate Procedure through 12 Month Follow-up ]
  • Measurement of Tumor Volume [ Time Frame: Baseline through 12 Month Follow Up ]

Central Contacts and Locations

Locations

Children's National Medical Center

Recruiting

Washington D.C., District of Columbia, United States, 20010

Contacts

Sonora Robles

202-476-3755srobles@childrensnational.org

Principal Investigator:

Robert Keating

Nicklaus Children's Hospital

Recruiting

Miami, Florida, United States, 33155

Contacts

The Focused Ultrasound Team

305-662-8386mrguidedfus@Nicklaushealth.org

John Ragheb, MD

305-662-8386john.ragheb2@nicklaushealth.org

Principal Investigator:

John Ragheb, MD

Texas Children's Hospital

Recruiting

Houston, Texas, United States, 77030

Contacts

Sarah Martinez

832-822-4075sxwisor@texaschildrens.org

Principal Investigator:

Daniel Curry, MD

More Information

Sponsor

InSightec

Last update posted

Jun 29, 2026

Last verified

May, 2026

Keywords

  • Hamartoma
  • Hypothalamic Hamartoma

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by InSightec on 2026-06-29.