A Feasibility Safety Study of Benign Centrally-Located Intracranial Tumors in Pediatric and Young Adult Subjects
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age5-22
SponsorInSightec
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
ExAblate 4000 System
DeviceFocused ultrasound
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: ExAblate 4000 SystemExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of Treatment-Emergent Adverse Events Safety and Tolerability
Safety will be assessed by tabulation of treatment related adverse events. All adverse events at least possibly procedure related will also be examined in detail for patterns of occurrence.
Time frame
Post ExAblate Procedure through 12 Month Follow-up2
Measurement of Tumor Volume
ExAblate procedure will demonstrate feasibility along with measurement of tumor volumes at follow-up as compared to the baseline MRI.
Time frame
Baseline through 12 Month Follow UpSecondary outcomes
1
Changes in the General Physical Exam
Any changes in physical examination performed by a physician.
Time frame
Baseline through 12 Month Follow Up2
Changes in the Neurological Exam
Any changes in neurological examination performed by the neurologist/neurosurgeon.
Time frame
Baseline through 12 Month Follow Up3
Confrontational Visual Field Testing
Changes in confrontational visual field testing performed by a physician
Time frame
Baseline through 3 Month Follow Up4
Global Impression of Change-Clinician
Impression of change as the result of the treatment by a physician
Time frame
Day 1 through 12 Month Follow UpOther outcomes
1
Change in Seizure Frequency
The change in seizure frequency will be evaluated from baseline through 12 months after treatment.
Time frame
From baseline through 12 months after treatment2
QOLCE-55
The change in scores on the QOLCE-55 questionnaire will be evaluated.
Time frame
From baseline through 12 months after treatment Source ClinicalTrials.gov