This feasibility study will assess the effects of the Nativis Voyager therapy in patients with recurrent GBM who have either failed standard of care or are intolerant to therapy. The study will enroll and treat up to eleven subjects over six months. Safety and clinical utility will be evaluated.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
11
Non-invasive RFE therapy
St. Vincent's Hospital Melbourne
Melbourne, Victoria, Australia
Incidence and evaluation of any serious adverse events associated with the Nativis Voyager System
Time frame: 6 months
Tumor Response
Tumor imaging response (RANO) at two months of therapy.
Time frame: 2 months
Overall survival at six months compared with historical response
Time frame: 6 months
Progression free survival
Time frame: 6 months
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