Actively Recruiting
A Feasibility Safety Study of 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
513 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official 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 which require clinical intervention and are known to carry minimal hemorrhage risk
- Minimum head circumference of 49 cm
- Skull Density Ratio (SDR) of at least 0.35
- Stable dose of all condition-related medications for 30 days prior to study entry
- Ability of subjects and/or parent(s)/legal representative to provide accurate seizure diary log for the 30 days prior to treatment and during the study
You will not qualify if you...
- Unstable cardiac status increasing anesthetic risk
- Behavior consistent with ethanol or substance abuse as defined by DSM-IV
- Taking human growth hormone (somatotropin)
- Standard contraindications for MRI such as non-MRI compatible implanted metallic devices (vagus nerve stimulator, neurostimulator, pacemakers, etc.) or size limitations
- Known intolerance or allergy to MRI contrast agents or sedative medications
- Severely impaired renal function or dialysis
- History of significant abnormal bleeding or coagulopathy
- Receiving anticoagulant or antiplatelet therapy within one week of procedure or drugs increasing hemorrhage risk within one month
- Use of valproate derivatives for seizure control within two weeks prior
- Known or suspected acute, active, or uncontrolled infection
- History of postnatal stroke or intracranial hemorrhage within six months
- Clinical suspicion of increased intracranial pressure
- Participation in another interventional trial within 30 days
- History of immunocompromise including incompletely suppressed HIV
- Known life-threatening systemic disease
- Suicidal ideation or attempt within past year
- Malignant brain tumors or ambiguous features suggesting malignancy
- Need for biopsy or histopathology for ongoing management
- Female subjects who are pregnant, breastfeeding, planning pregnancy, or unwilling to use birth control if of childbearing age
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
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