MRI-Guided Focused Ultrasound Feasibility Study for Brain Tumors

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by InSightec
Sponsor:
Information provided by (Responsible Party):
InSightec
ClinicalTrials.gov Identifier:
NCT00147056
First received: September 2, 2005
Last updated: June 12, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Brain Tumor
Device: ExAblate transcranial system
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Study to Evaluate the Safety and Feasibility of Transcranial MRI-Guided Focused Ultrasound Surgery in the Treatment of Brain Tumors

Resource links provided by NLM:


Further study details as provided by InSightec:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 10
Study Start Date: August 2012
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ExAblate transcranial system
MR Guided Focused Ultrasound
Device: ExAblate transcranial system
MRI-Guided Focused Ultrasound Feasibility Study for Brain

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.
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Tumor(s) are clearly defined on pre-therapy contrast enhanced MRI scans.
  2. Men or women.
  3. Age between 18 and 70 years, inclusive.
  4. Karnofsky rating 70-100.
  5. ASA score 1-2.
  6. Able and willing to give informed consent.
  7. Able to communicate sensations during the ExAblate MRGFUS procedure.
  8. Apparently able to attend all study visits (i.e., life expectancy of at least 3 months).
  9. At least 14 days passed since last brain surgery, or intracranial radiation therapy/radiosurgery
  10. No additional tumor brain surgery nor radiation therapy anticipated for at least 14 days.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00147056

Locations
United States, Virginia
University of Virginia Recruiting
Charlottesville, Virginia, United States, 22908
Contact: Jenny DeJong, MSN, RN    434-243-9986    jad5yc@virginia.edu   
Contact: Amy Warren    434-243-9986    alh3p@virginia.edu   
Principal Investigator: Jason Sheehan, MD         
United States, Washington
Swedish Medical Center Recruiting
Seattle, Washington, United States, 98122
Contact: Colleen Ottinger    206-320-3070    Focusedultrasound@swedish.org   
Contact: Mary Lessig    206-320-3070    Focusedultrasound@swedish.org   
Principal Investigator: Charles Cobbs, MD         
Sponsors and Collaborators
InSightec
  More Information

Additional Information:
No publications provided

Responsible Party: InSightec
ClinicalTrials.gov Identifier: NCT00147056     History of Changes
Other Study ID Numbers: BT002
Study First Received: September 2, 2005
Last Updated: June 12, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by InSightec:
Brain tumor
Brain Lesions
Brain Cancer
ExAblate

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

ClinicalTrials.gov processed this record on July 22, 2014