Table 3.

Key inclusion and exclusion criteria.

Inclusion

Exclusion

Men or women 18 to 75 years, inclusive Able and willing to give informed consent Malignant brain tumor confirmed by biopsy or suspected based on imaging Tumor is clearly defined on pre-therapy contrast enhanced MRI scans Size of the targeted portion of the tumor (i.e. prescribed ROT) is less than 2.5 cm in diameter (16 cm3). The non-targeted tumor tissue may exceed the targeted volume Karnofsky rating 70-100 ASA score 1–3 At least 14 days passed since last brain surgery

Previously irradiated tumor or tumor site Previous full course of chemotherapy Contraindication to MRI Tumor presenting with the following imaging characteristics: brain edema or mass effect with midline shift > 10 mm after steroid treatment, recent intracranial hemorrhage Evidence of increased intracranial pressure Unstable cardiovascular or pulmonary disease, cardiac shunt Abnormal coagulation Cerebral or systemic vasculopathy Insulin-dependent diabetes mellitus