MRI-Guided Focused Ultrasound Feasibility Study for Brain Tumors

This study is currently recruiting participants.
Verified March 2014 by InSightec
Sponsor:
Information provided by (Responsible Party):
InSightec
ClinicalTrials.gov Identifier:
NCT00147056
First received: September 2, 2005
Last updated: March 25, 2014
Last verified: March 2014
  Purpose

The purpose of this study is to evaluate the safety of MRI-guided focused ultrasound thermal ablation of brain lesions performed through intact human skull using the ExAblate 3000 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. The hypothesis of the study is to determine if FUS under MRI-guidance and MRI-based thermometry can be safely delivered through an intact human skull with a low risk of transient short-term adverse effects as evaluated during follow-up of up to 3 months and a pre-defined target volume inside the brain lesion can be accurately ablated, as shown on post-treatment MRI.


Condition Intervention Phase
Glioblastoma
Recurrent Metastatic Cancer to the Brain
Device: ExAblate 4000
Phase 1

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

Resource links provided by NLM:


Further study details as provided by InSightec:

Primary Outcome Measures:
  • MRI Guilded Focused ultrasound feasibility study for brain tumors [ Time Frame: 2 years ] [ Designated as safety issue: No ]

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 400
MR Guided Focused Ultrasound
Device: ExAblate 4000
MRI-Guided Focused Ultrasound Feasibility Study for Brain

Detailed Description:

Non-invasive focused ultrasound surgery has special appeal for use inside the skull, where it is desirable to destroy lesions deep in the brain without damage to the surrounding brain tissue or other structures.

The ExAblate systems are the result of an 8-year development by InSightec and GE Medical Systems. These systems combine a focused ultrasound surgery (FUS) delivery system and a conventional diagnostic 1.5 T MRI scanner.

The ExAblate 2000 system is being used at Brigham and Women's (BWH) and in about a dozen other hospitals around the world for clinical trials in for the treatment of uterine fibroids, breast fibroadenoma, and breast carcinoma.

  Eligibility

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

Inclusion Criteria:

  1. Subjects with only recurrent glioblastoma (grade IV astro) and recurrent metastatic cancer to the brain for whom surgery has not been advised by a physician that is not associated with this study.
  2. Lesion(s) to be treated are located in the cerebral hemispheres, > 1.5 cm from the cortex and the dura.
  3. Lesion(s) are clearly defined on pre-therapy contrast enhanced MRI scans.
  4. Three or less lesion(s) in the brain
  5. Size of solid mass of lesions is less than 2.5 cm in diameter (8 cm3 in volume).
  6. Men or women.
  7. Age between 18 and 70 years, inclusive.
  8. Karnofsky rating 70-100 (See Appendix A).
  9. ASA score 1-2.
  10. Able and willing to give informed consent.
  11. Able to communicate sensations during the MRGFUS procedure.
  12. Apparently able to attend all study visits (i.e., life expectancy of at least 3 months).
  13. At least 14 days passed since last tumor therapy (i.e. surgery, chemotherapy, radiation therapy). .
  14. No additional tumor therapies anticipated for at least 30 days (i.e. surgery, chemotherapy, radiation therapy).

Exclusion Criteria:

a) The lesion's appearance on the pre-therapy MR and CT scans:

  1. Brain edema and/or mass effect that causes midline shift or shift in wall of ventricle of more than 5 mm.
  2. Localized in the brain stem or the posterior fossa.
  3. Less than 5mm from primary branches of cerebral vessels, venous sinus, hypophysis or cranial nerves.
  4. Evidence of recent (less than 2 weeks) hemorrhage.
  5. Containing calcifications. b) The sonication pathway to the lesion involves:

a. More than 30% of the skull area traversed by the sonication pathway is covered by scars, scalp disorders (e.g., eczema), or atrophy of the scalp.

b. Clips or other implanted objects in the skull or the brain. c) The subject presents with:

  1. Symptoms and signs of increased intracranial pressure (e.g., headache, nausea, vomiting, lethargy, and papaedama).
  2. 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). c. Anti-coagulation therapy or known bleeding disorder. d. Abnormal level of platelets (< 100), PT (>14) or PTT (>36). e. Documented cerebral infarction within past 12 months. f. TIA due to arteriosclerosis in the last 1 month. g. Other known cerebral or general vasculopathy. h. Insulin-dependent diabetes mellitus. i. Immunosuppression (corticosteroids to prevent brain edema are permitted). j. Known sensitivity to gadolinium-DTPA. k. Contraindications to MRI such as non-MRI-compatible implanted devices. l. Large subjects not fitting comfortably into the MRI scanner (generally >250 lbs.) m. Difficulty to lay supine and still for up to 4 hours in the MRI unit or claustrophobia.

n. Sleep apnea. o. Positive pregnancy test (for pre-menopausal women). p. Known life-threatening systemic disease.

  Contacts and Locations
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   
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: March 25, 2014
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Brain Neoplasms
Glioblastoma
Neoplasm Metastasis
Neoplasms
Neoplasms, Second Primary
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplastic Processes
Pathologic Processes

ClinicalTrials.gov processed this record on April 22, 2014