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MRI-Guided Focused Ultrasound Feasibility Study for Brain Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00147056
Recruitment Status : Active, not recruiting
First Posted : September 7, 2005
Last Update Posted : March 10, 2020
Sponsor:
Information provided by (Responsible Party):
InSightec

Tracking Information
First Submitted Date  ICMJE September 2, 2005
First Posted Date  ICMJE September 7, 2005
Last Update Posted Date March 10, 2020
Study Start Date  ICMJE August 2012
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 4, 2014)
Number of subjects with Serious and Non-Serious Adverse Events after MRI Guided Focused ultrasound treatment for brain tumors [ Time Frame: Up to 3 months ]
To evaluate the safety of ExAblate TcMRgFUS treatment delivered through intact human skull to the brain, during the treatment and during the follow-up period of 3 months.
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE MRI-Guided Focused Ultrasound Feasibility Study for Brain Tumors
Official Title  ICMJE A Study to Evaluate the Safety and Feasibility of Transcranial MRI-Guided Focused Ultrasound Surgery in the Treatment of Brain Tumors
Brief Summary The purpose of this study is to evaluate the safety of MRI-guided focused ultrasound thermal ablation of brain tumors performed through intact human skull using the ExAblate transcranial system. We will collect data to establish the basic safety of this type of treatment as the basis for later studies that will evaluate its clinical efficacy.
Detailed Description

In this non-randomized feasibility study, FUS under MRI-guidance and thermometry will be given through intact human skull to brain tumor in up to ten (10) subjects. These subjects will be followed over a 3-month period with contrast MRI and clinical exams.

The objectives are:

  1. To evaluate the safety of ExAblate TcMRgFUS treatment delivered through intact human skull to the brain, during the treatment, and during the follow-up period of 3 months.
  2. To evaluate the effect of thermal ablation in the target tumor with contrast MR imaging to identify viable tumor, and non-viable thermally ablated tissue.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Brain Tumor
Intervention  ICMJE Device: ExAblate transcranial system
MRI-Guided Focused Ultrasound Feasibility Study for Brain
Study Arms  ICMJE Experimental: ExAblate transcranial system
MR Guided Focused Ultrasound
Intervention: Device: ExAblate transcranial system
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: September 2, 2005)
10
Original Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2022
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Men or women.
  2. Age between 18 and 70 years, inclusive.
  3. Able and willing to give informed consent.
  4. Subjects with (newly diagnosed or recurrent) metastatic cancer for whom surgery, radiation, or radiosurgery has not been advised by the treating physician.
  5. The targeted tumor tissue is located in the cerebral hemispheres, > 2.5 cm from the inner table of the skull. Non-targeted parts of the tumor may extend outside the treated tumor limits.
  6. Tumor(s) are clearly defined on pre-therapy contrast enhanced MRI scans.
  7. Size of the targeted portion of the tumor (i.e. prescribed Region Of Treatment) is less than 2.5 cm in diameter or 8 cm3 in volume. The non-targeted tumor tissue may exceed the targeted volume.
  8. Karnofsky rating 70-100 (See Appendix A).
  9. ASA score 1-2.
  10. Able to communicate sensations during the ExAblate MRGFUS procedure.
  11. Able to attend all study visits (i.e. life expectancy of at least 3 months).
  12. At least 14 days passed since last brain surgery, or intracranial radiation therapy/radiosurgery

Exclusion Criteria:

  1. The subject presents with:

    - Symptoms and signs of increased intracranial pressure (e.g., headache, nausea, vomiting, lethargy, and papaedema).

    - Unstable hemodynamic status including: i. Documented myocardial infarction within six months of enrollment. ii.Symptomatic coronary artery stenosis. iii. Congestive heart disease requiring medication. iv. Anti-arrhythmic drug medication. v. Cardiac pacemaker. vi. Severe hypertension (diastolic BP > 100 on medication).

  2. Anti-coagulant therapy, on medications known to increase risk of hemorrhage, (e.g.: non-steroidal anti-inflammatory drugs (NSAIDs), statins
  3. TIA or stroke in the last 1 month
  4. Insulin-dependent diabetes mellitus
  5. Immunosuppression (corticosteroids to prevent brain edema are permitted)
  6. Known sensitivity to gadolinium-DTPA
  7. Contraindications to MRI such as non-MRI-compatible implanted devices
  8. Large subjects not fitting comfortably into the MRI scanner
  9. Difficulty laying supine and still for up to 4 hours in the MRI unit or claustrophobia
  10. Untreated, uncontrolled Sleep apnea
  11. Positive pregnancy test (for pre-menopausal women)
  12. Known life-threatening systemic disease
  13. More than 3 metastatic tumors
  14. History of abnormal bleeding and coagulopathy
  15. Use of Avastin in the preceding two weeks or planned use in the forthcoming two weeks and VEGF inhibitors within + 30 days of treatment
  16. Patients with a history of uncontrolled seizures or who are not on anti seizure medication (e.g., Phenytoin 100 mg PO t.i.d. or Keppra 500 mg po bid) before the procedure
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00147056
Other Study ID Numbers  ICMJE BT002
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party InSightec
Study Sponsor  ICMJE InSightec
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account InSightec
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP