A Feasibility Safety Study of Benign Centrally-Located Intracranial Tumors in Pediatric and Young… (NCT03028246) | Clinical Trial Compass
RecruitingNot Applicable
A Feasibility Safety Study of Benign Centrally-Located Intracranial Tumors in Pediatric and Young Adult Subjects
United States20 participantsStarted 2017-02-28
Plain-language summary
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.
Who can participate
Age range5 Years – 22 Years
SexALL
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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…
What they're measuring
1
Incidence of Treatment-Emergent Adverse Events Safety and Tolerability
Timeframe: Post ExAblate Procedure through 12 Month Follow-up