Evaluating the safety of ExAblate treatment for benign brain tumors in children and young adults
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
This study is testing whether the ExAblate treatment is safe for children and young adults with benign brain tumors.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 5 Years to 22 Years |
| Sex | All |
| Sponsor | InSightec Industry-sponsored |
| Locations | 3 sites (Washington D.C., District of Columbia and 2 other locations) |
| Trial ID | NCT03028246 on ClinicalTrials.gov |
What this trial studies
This prospective, non-randomized, single-arm feasibility study aims to assess the safety and feasibility of using the ExAblate 4000 system to treat benign centrally-located intracranial tumors in pediatric and young adult patients. The study will collect data on the management of tumor size and the overall safety of the procedure. Participants will be monitored for their response to treatment and any potential adverse effects. The findings will inform future studies and treatment protocols for this patient population.
Who should consider this trial
Good fit: Ideal candidates include pediatric and young adult patients with benign centrally-located intracranial tumors that require clinical intervention and have minimal hemorrhage risk.
Not a fit: Patients with unstable cardiac conditions or those with contraindications for MR imaging will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a non-invasive option for managing benign brain tumors in young patients, potentially reducing the need for more invasive surgical interventions.
How similar studies have performed: While this approach is innovative, similar studies using focused ultrasound for tumor treatment have shown promise, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Washington D.C., District of Columbia and 2 other locations
- Children's National Medical Center — Washington D.C., District of Columbia, United States (Recruiting)
- Nicklaus Children's Hospital — Miami, Florida, United States (Recruiting)
- Texas Children's Hospital — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: John Ragheb, MD — Miami Children's Research Institute - Nicklaus Children's Hospital
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.