MRI-Guided Focused Ultrasound Feasibility Study for Brain Tumors

Status: Recruiting
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 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.

 

Conducting Institutions:
Brigham and Women's Hospital, Dana-Farber Cancer Institute

Overall PI:
Ferenc Jolesz, MD, Brigham and Women's Hospital

Site-responsible Investigators:

Contacts:
Dana-Farber Cancer Institute: Lisa Doherty, ldoherty1@partners.org

Eligibility 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.
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