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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 (NCT03028246)

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.
  • Device: ExAblate 4000 System
    • MRgFUS
    • HIFU
    • Focused Ultrasound
    • MR-Guided Focused Ultrasound
    • ExAblate Neuro System
Ages eligible for Study
8 Years to 22 Years
Genders eligible for Study
All
Accepts Healthy Volunteers
No
Inclusion Criteria:
  • Males and females age 8 to 22 years who are scheduled for neurosurgery, staged for recruitment by age subcategories from oldest to youngest age groups.
  • Subjects with benign (WHO grade I) centrally located intracranial tumors which require clinical intervention (see Appendix II) and are known to carry minimal hemorrhage risk.
  • Minimum head circumference will be 52cm
  • Skull Density Ratio (SDR) should be ≥0.40.
  • Planned treatment volume should not exceed 8-cm3
  • Subjects should be on a stable dose of all condition-related medications for 30 days prior to study entry as determine by medical records.
  • Cleared for general anesthesia (if required) per local standards.
  • Subjects and/or parent(s)/legal representative are able and willing to give informed consent and able to attend all study visits
Exclusion Criteria:
  • Subjects with unstable cardiac status that would increase anesthetic risk including
  • congenital heart disease which is uncompensated or unstable
  • Unstable angina pectoris on medication
  • Subjects with documented myocardial infarction within six months of protocol entry
  • Congestive heart failure requiring medication (other than diuretic)
  • Subjects on anti-arrhythmic drugs
  • Subjects exhibiting any behavior(s) consistent with ethanol or substance abuse as defined by the criteria outlined in the DSM-IV as manifested by one (or more) of the following occurring within a 12 month period:
  • Recurrent substance use resulting in a failure to fulfill major role obligations at work, school, or home (such as repeated absences or poor work performance related to substance use; substance-related absences, suspensions, or expulsions from school; or neglect of children or household).
  • Recurrent substance use in situations in which it is physically hazardous (such as driving an automobile or operating a machine when impaired by substance use)
  • Recurrent substance-related legal problems (such as arrests for substance related disorderly conduct)
  • Continued substance use despite having persistent or recurrent social or interpersonal problems caused or exacerbated by the effects of the substance (for example, arguments with spouse about consequences of intoxication and physical fights).
  • 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.
  • Subjects who have used valproate derivatives for seizure control within the preceding 2 weeks (due to the inhibitory effect on platelet function)
  • 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 o Unstable psychiatric disease, defined as active uncontrolled depressive symptoms, psychosis, delusions, hallucinations, or suicidal ideation. Subjects with stable, chronic anxiety or depressive disorders may be included provided their medications have been stable for at least 60 days prior to study entry and if deemed appropriately managed by the site neuropsychologist
  • 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.
  • Subjects who have contraindications to anesthesia, in the judgment of the attending anesthesiologist
  • Subjects who are unwilling or unable to undergo general anesthesia
  • Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the subject or the quality of the data.
  • Minimum head circumference < 52cm
  • Skull Density Ratio (SDR) <0.40.
  • Planned treatment volume > 8-cm3
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.

This is a feasibility study intended to collect data for use in the development of future studies. As such, no formal statistical hypothesis or hypothesis testing is proposed. The purpose of this study is to evaluate the safety and feasibility of managing benign brain tumor size using ExAblate 4000 treatment of progressing benign intracranial tumors which require clinical intervention in pediatric and young adult subjects.

1 locations

United States (1)
  • Miami Children's Research Institute - Nicklaus Children's Hospital
    recruiting
    Miami, Florida, United States, 33155
Status:
recruiting
Type:
Interventional
Phase:
-
Start:
11 January, 2017
Updated:
31 July, 2017
Participants:
10
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