MRI-Guided Focused Ultrasound Feasibility Study for Brain Tumors

Sponsor

InSightec (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT00147056

Collaborator

(none)

Enrollment

Locations

Arm

124

Duration (Months)

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Brain Tumor	Device: ExAblate transcranial system	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

10 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (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

Study Start Date :

Aug 1, 2012

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ExAblate transcranial system MR Guided Focused Ultrasound	Device: ExAblate transcranial system MRI-Guided Focused Ultrasound Feasibility Study for Brain

Arm

Intervention/Treatment

Experimental: ExAblate transcranial system

MR Guided Focused Ultrasound

Device: ExAblate transcranial system

MRI-Guided Focused Ultrasound Feasibility Study for Brain

Outcome Measures

Primary Outcome Measures

Number of subjects with Serious and Non-Serious Adverse Events after MRI Guided Focused ultrasound treatment for brain tumors [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Men or women.
Age between 18 and 70 years, inclusive.
Able and willing to give informed consent.
Subjects with (newly diagnosed or recurrent) metastatic cancer for whom surgery, radiation, or radiosurgery has not been advised by the treating physician.
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.
Tumor(s) are clearly defined on pre-therapy contrast enhanced MRI scans.
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.
Karnofsky rating 70-100 (See Appendix A).
ASA score 1-2.
Able to communicate sensations during the ExAblate MRGFUS procedure.
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

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