MRI-Guided Focused Ultrasound Feasibility Study for Brain Tumors
This study is currently recruiting participants.
(see Contacts and Locations)
Verified November 2014 by InSightec
Sponsor:
InSightec
Information provided by (Responsible Party):
InSightec
ClinicalTrials.gov Identifier:
NCT00147056
First received: September 2, 2005
Last updated: November 11, 2014
Last verified: November 2014
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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: | December 2014 |
| Estimated Primary Completion Date: | December 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:
- 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.
- 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:
- Tumor(s) are clearly defined on pre-therapy contrast enhanced MRI scans.
- Men or women.
- Age between 18 and 70 years, inclusive.
- Karnofsky rating 70-100.
- ASA score 1-2.
- Able and willing to give informed consent.
- Able to communicate sensations during the ExAblate MRGFUS procedure.
- Apparently able to attend all study visits (i.e., life expectancy of at least 3 months).
- At least 14 days passed since last brain surgery, or intracranial radiation therapy/radiosurgery
- No additional tumor brain surgery nor radiation therapy anticipated for at least 14 days.
Exclusion Criteria:
-
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).
- Anti-coagulant therapy, on medications known to increase risk of hemorrhage, (e.g.: non-steroidal anti-inflammatory drugs (NSAIDs), statins
- TIA or stroke in the last 1 month
- Insulin-dependent diabetes mellitus
- Immunosuppression (corticosteroids to prevent brain edema are permitted)
- Known sensitivity to gadolinium-DTPA
- Contraindications to MRI such as non-MRI-compatible implanted devices
- Large subjects not fitting comfortably into the MRI scanner
- Difficulty laying supine and still for up to 4 hours in the MRI unit or claustrophobia
- Untreated, uncontrolled Sleep apnea
- Positive pregnancy test (for pre-menopausal women)
- Known life-threatening systemic disease
- More than 3 metastatic tumors
- History of abnormal bleeding and coagulopathy
- Use of Avastin in the preceding two weeks or planned use in the forthcoming two weeks and VEGF inhibitors within + 30 days of treatment
- 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00147056
Locations
| United States, Massachusetts | |
| Brigham and Women's Hospital | Recruiting |
| Boston, Massachusetts, United States, 02115 | |
| Contact: Danielle Chamberlain 617-525-8596 dchamberlain1@partners.org | |
| Principal Investigator: Ferenc Jolesz, 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: | November 11, 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 Brain Diseases Central Nervous System Diseases Central Nervous System Neoplasms |
Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms |
ClinicalTrials.gov processed this record on February 27, 2015