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A Feasibility Study to Evaluate the Safety and Feasibility of Transcranial MRI-Guided Focused Ultrasound Surgery in the Treatment of Brain Lesions

Phase 1
18 Years
70 Years
Not Enrolling
Glioblastoma, Recurrent Metastatic Cancer to the Brain

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Trial Information

A Feasibility Study to Evaluate the Safety and Feasibility of Transcranial MRI-Guided Focused Ultrasound Surgery in the Treatment of Brain Lesions

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.

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

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

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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

MRI Guilded Focused ultrasound feasibility study for brain tumors

Outcome Time Frame:

2 years

Safety Issue:



United States: Food and Drug Administration

Study ID:




Start Date:

August 2012

Completion Date:

August 2013

Related Keywords:

  • Glioblastoma
  • Recurrent Metastatic Cancer to the Brain
  • Brain tumor
  • Brain Lesions
  • Brain Cancer
  • ExAblate
  • Glioblastoma
  • Brain Neoplasms
  • Glioblastoma
  • Neoplasm Metastasis
  • Neoplasms
  • Neoplasms, Second Primary