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This study is to evaluate the safety and find the tolerated ultrasound dose of transient opening of the blood-brain barrier (BBB) by using the NaviFUS System in recurrent GBM patients.
Full description
This is a feasibility, open-label, single-arm, and dose escalation study. Eligible patients will be enrolled through the process of informed consent. Patients will be assigned into different dose groups generated from the NaviFUS System to transiently open the BBB in patients with recurrent GBM who will undergo surgery within 2 weeks. The focused ultrasound (FUS) dose is selected based on the results of pre-clinical Good Laboratory Practice (GLP) safety studies as well as other non-GLP primate studies. This study will evaluate the safety and the tolerated ultrasound dose of temporary disruption of the BBB in patients with recurrent GBM. To find the tolerated ultrasound dose, the data and safety monitoring board (DSMB) will review the study data and provide the recommendations regarding continuation, termination, or other modifications of the study based on evaluation of observed adverse effects of the intervention. The extent and magnitude of BBB opening will be evaluated using of dynamic contrast-enhanced MRI (DCE-MRI).
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Inclusion criteria
Patients diagnosed with recurrent GBM and will undergo surgery
Able to give written informed consent for the participation in the trial
Adult male/female patients > 20 years of age
Patients if already on radiotherapy, a gap of 7 days shall be maintained between the last day of radiotherapy and the day of screening
Patients if already on the steroids treatment, then should be on a stable dose of steroids for at least 7 days prior to screening
Body mass index (BMI) ≥17 kg / m2
Patients with life expectancy ≥ 3 months
Able to comply with study requirements in the opinion of the investigator
Adequate hepatic, renal, coagulation, and hematopoietic function
Patients with the ROI for FUS exposure are located close to the cortex with at least 20 mm distance beneath the skull bone and the ROI is not in the deep center brain with crucial brain functions, such as in the region of brain stem, or motor or speech regions
The Karnofsky performance status (KPS) in the patient must be > 60
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6 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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