MRI-Guided Focused Ultrasound Feasibility Study for Brain Tumors
Phase: Phase 1
Diagnosis: Brain/Neuro Cancer: Newly Diagnosed
NCT ID: NCT00147056
(View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 13-016
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.
Brigham and Women's Hospital, Dana-Farber Cancer Institute
Ferenc Jolesz, MD,
Brigham and Women's Hospital
Dana-Farber Cancer Institute:
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
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).
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
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
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.