Actively Recruiting
A Feasibility Safety Study Using the ExAblate 4000 System for Benign Centrally-Located Intracranial Tumors in Pediatric and Young Adult Subjects
Led by InSightec · Updated on 2026-05-08
20
Participants Needed
3
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the safety and feasibility of using the ExAblate 4000 System, a focused ultrasound device, to treat benign centrally located brain tumors in children and young adults aged 5 to 22 years. The study aims to gather data to support future research on managing these tumors, which require clinical intervention and are accessible to the ExAblate device. Participants will receive treatment with the ExAblate 4000 System in a single-arm, non-randomized setting. This means all enrolled subjects will undergo the focused ultrasound procedure targeting their benign brain tumors. The study does not include a comparison group, and its main purpose is to assess safety and feasibility rather than test effectiveness. Throughout the study, participants will be monitored closely with assessments including tumor volume measurements and evaluations of physical and neurological health for up to 12 months after treatment. Researchers will also track side effects, visual field function, and both clinician and patient impressions of change. This detailed follow-up helps understand how the treatment affects the tumor and overall health over time.
CONDITIONS
Brief Title
A Feasibility Safety Study of Benign Centrally-Located Intracranial Tumors in Pediatric and Young Adult Subjects
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subjects with benign (WHO grade I) centrally located intracranial tumors requiring clinical intervention and minimal hemorrhage risk
- Minimum head circumference of 49 cm
- Skull Density Ratio (SDR) of at least 0.35
- Stable dose of condition-related medications for 30 days before study entry
- Ability to provide accurate seizure diary logs for 30 days before treatment and during the study
You will not qualify if you...
- Unstable cardiac status increasing anesthetic risk
- Behaviors consistent with ethanol or substance abuse
- Use of human growth hormone (somatotropin)
- Non-MRI compatible implanted metallic devices (e.g., vagus nerve stimulator, pacemakers)
- Known allergies to MRI contrast agents or sedative medications
- Severely impaired kidney function or dialysis
- History of significant bleeding or coagulopathy
- Use of anticoagulants or drugs increasing hemorrhage risk within specified timeframes
- Use of valproate derivatives for seizure control within 2 weeks prior
- Active or uncontrolled infection
- Postnatal stroke or intracranial hemorrhage within 6 months
- Signs of increased intracranial pressure
- Participation in another interventional trial within 30 days
- History of immunocompromise or incomplete HIV viral suppression
- Life-threatening systemic disease
- Suicidal ideation or attempts within the past year
- Malignant brain tumors or ambiguous features requiring biopsy
- Pregnancy, breastfeeding, or unwillingness to use birth control if of child-bearing age
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single treatment session
Participants receive treatment with the ExAblate 4000 System using MR-guided focused ultrasound to ablate benign centrally located intracranial tumors.
1 treatment visit (in-person)
Duration - Up to 12 months
Participants are monitored for safety, tumor volume changes, neurological and physical exam changes, and overall clinical impressions following treatment.
Multiple follow-up visits through 12 months
Trial Site Locations
Total: 3 locations
1
Children's National Medical Center
Washington D.C., District of Columbia, United States, 20010
Actively Recruiting
2
Nicklaus Children's Hospital
Miami, Florida, United States, 33155
Actively Recruiting
3
Texas Children's Hospital
Houston, Texas, United States, 77030
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Frequently Asked Questions
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