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Tests treatment safety and results for Benign Centrally-Located Intracranial Tumors
Official title A Feasibility Safety Study of Benign Centrally-Located Intracranial Tumors in Pediatric and Young Adult Subjects
ClinicalTrials.gov ID: NCT03028246
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 5 to 22
You may be able to join if
- people with benign (WHO grade I) centrally located intracranial tumors which require clinical intervention and are known to carry minimal hemorrhage...
- Minimum head circumference will be 49cm
- Skull Density Ratio (SDR) should be ≥0.35
- people should be on a stable dose of all condition-related medications for 30 days prior to study entry as determine by medical records
- people 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...
You likely can't join if
- people with unstable cardiac status that would increase anesthetic risk including
- people exhibiting any behavior(s) consistent with ethanol or substance abuse as defined by the criteria outlined in the DSM-IV
- people who are taking human growth hormone (hGH), also known as somatotropin
- people with standard contraindications for MR imaging such as non-MRI compatible implanted metallic devices including vagus nerve stimulator...
- 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
See the full eligibility criteria
- people 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
- people should be on a stable dose of all condition-related medications for 30 days prior to study entry as determine by medical records
- people 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
- people with unstable cardiac status that would increase anesthetic risk including
- people exhibiting any behavior(s) consistent with ethanol or substance abuse as defined by the criteria outlined in the DSM-IV
- people who are taking human growth hormone (hGH), also known as somatotropin
- people 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...
- 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...
- 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 treatment trial in the last 30 days
- History of immunocompromise, including subject who is HIV positive with incomplete viral suppression
- Known life-threatening systemic disease
- people with suicidal ideation or previous suicide attempt within the past year
- people 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
- people for whom histopathology is important for ongoing management
- Female people 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
The study team makes the final eligibility decision.
Where it's taking place
- Washington D.C., District of Columbia, United States
- Miami, Florida, United States
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 5 years to 22 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Washington D.C., District of Columbia, United States; Miami, Florida, United States; Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.