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Trial record 2 of 2 for:    Recruiting, Enrolling by invitation Studies | Benign Brain Tumor

A Feasibility Safety Study of Benign Centrally-Located Intracranial Tumors in Pediatric and Young Adult Subjects

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ClinicalTrials.gov Identifier: NCT03028246
Recruitment Status : Recruiting
First Posted : January 23, 2017
Last Update Posted : June 27, 2018
Sponsor:
Information provided by (Responsible Party):
InSightec

Brief 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.


Condition or disease Intervention/treatment Phase
Benign Centrally-Located Intracranial Tumors Device: ExAblate 4000 System Not Applicable

Detailed Description:

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : February 28, 2017
Estimated Primary Completion Date : March 31, 2020
Estimated Study Completion Date : December 31, 2021

Arm Intervention/treatment
Experimental: ExAblate 4000 System
MR-Guided Focused Ultrasound
Device: ExAblate 4000 System
Focused ultrasound
Other Names:
  • MRgFUS
  • HIFU
  • Focused Ultrasound
  • MR-Guided Focused Ultrasound
  • ExAblate Neuro System




Primary Outcome Measures :
  1. Incidence of Treatment-Emergent Adverse Events Safety and Tolerability [ Time Frame: Post ExAblate Procedure through 12 Month Follow-up ]
    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.

  2. Measurement of Tumor Volume [ Time Frame: Baseline through 12 Month Follow Up ]
    ExAblate procedure will demonstrate feasibility along with measurement of tumor volumes at follow-up as compared to the baseline MRI.


Secondary Outcome Measures :
  1. Changes in the General Physical Exam [ Time Frame: Baseline through 12 Month Follow Up ]
    Any changes in physical examination performed by a physician.

  2. Changes in the Neurological Exam [ Time Frame: Baseline through 12 Month Follow Up ]
    Any changes in neurological examination performed by the neurologist/neurosurgeon.

  3. Confrontational Visual Field Testing [ Time Frame: Baseline through 3 Month Follow Up ]
    Changes in confrontational visual field testing performed by a physician

  4. Global Impression of Change-Clinician [ Time Frame: Day 1 through 12 Month Follow Up ]
    Impression of change as the result of the treatment by a physician

  5. Patient Global Impression of Change [ Time Frame: Day 1 through 12 Month Follow Up ]
    Impression of change as the result of the treatment by the subject



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Ages Eligible for Study:   8 Years to 22 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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.
  2. 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.
  3. Minimum head circumference will be 52cm
  4. Skull Density Ratio (SDR) should be ≥0.40.
  5. Planned treatment volume should not exceed 8-cm3
  6. Subjects should be on a stable dose of all condition-related medications for 30 days prior to study entry as determine by medical records.
  7. Cleared for general anesthesia (if required) per local standards.
  8. Subjects and/or parent(s)/legal representative are able and willing to give informed consent and able to attend all study visits

Exclusion Criteria:

  1. 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
  2. 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).
  3. Subjects who are taking human growth hormone (hGH), also known as somatotropin
  4. 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.
  5. Known intolerance or allergies to the MRI contrast agent (e.g. Gadolinium or Magnevist) or sedative medications
  6. Severely impaired renal function (estimated glomerular filtration rate <70% of normal GFR for age) or receiving dialysis
  7. Any history of clinically significant abnormal bleeding and/or coagulopathy
  8. 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.
  9. Subjects who have used valproate derivatives for seizure control within the preceding 2 weeks (due to the inhibitory effect on platelet function)
  10. Known or suspected acute, active, or uncontrolled infection
  11. History of postnatal stroke or intracranial hemorrhage within 6 months
  12. Clinical suspicion of increased intracranial pressure (as evidenced by symptoms of obstruction: headache, nausea, vomiting, lethargy, and papilledema)
  13. Have participated in another interventional trial in the last 30 days
  14. History of immunocompromise, including subject who is HIV positive with incomplete viral suppression
  15. Known life-threatening systemic disease
  16. 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

  17. 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
  18. Subjects for whom histopathology is important for ongoing management
  19. 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.
  20. Subjects who have contraindications to anesthesia, in the judgment of the attending anesthesiologist
  21. Subjects who are unwilling or unable to undergo general anesthesia
  22. 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.
  23. Minimum head circumference < 52cm
  24. Skull Density Ratio (SDR) <0.40.
  25. Planned treatment volume > 8-cm3

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03028246


Locations
United States, Florida
Miami Children's Research Institute - Nicklaus Children's Hospital Recruiting
Miami, Florida, United States, 33155
Contact: John Ragheb, MD    305-662-8386    john.ragheb2@nicklaushealth.org   
Contact: Tami Quintero    786-624-3516    researchinstitute@mch.com   
Principal Investigator: John Ragheb, MD         
Sub-Investigator: Ian Miller, MD         
Sponsors and Collaborators
InSightec
Investigators
Principal Investigator: John Ragheb, MD Miami Children's Research Institute - Nicklaus Children's Hospital

Responsible Party: InSightec
ClinicalTrials.gov Identifier: NCT03028246     History of Changes
Other Study ID Numbers: BT005
First Posted: January 23, 2017    Key Record Dates
Last Update Posted: June 27, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No

Additional relevant MeSH terms:
Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases