An Open Label, Prospective, Pilot Study To Evaluate The Safety And Effectiveness Of The NaviFUS System In Conjunction With A Standard Treatment Regimen Of Bevacizumab (BEV) In Patients With Recurrent Glioblastoma
University of Cincinnati
Summary
This study will evaluate the safety and early effectiveness of the NaviFUS system with concomitant microbubble administration in conjunction with BEV in recurrent GBM patients.
Description
The primary objective of this clinical investigation is to evaluate the safety of BEV combined with the NaviFUS System for the treatment of patients with recurrent GBM. Safety will be assessed using the following methods: Device-related Adverse Events (AEs) reported \[Time Frame: Through study completion, up to 24 weeks\]. To determine the incidence and severity of device-related AEs for bevacizumab plus NaviFUS System treatment in patients with recurrent glioblastoma multiforme (rGBM), the following safety parameters will be assessed: AEs, physical examination (PE), vital signs, neurologica…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Adult male/female patients ≥ 18 years of age. 2. Histologically confirmed glioblastoma at original diagnosis, recurrent after prior radiotherapy and temozolomide chemotherapy. 3. Must have measurable disease ≥ 10mm (according to RANO criteria) . 4. Interval since completion of radiation treatment (including radiation at original diagnosis and/or radiation for recurrent disease) ≥ 12 weeks. 5. If on steroids, must be on a stable dose for ≥ 7 days prior to study treatment. 6. Body mass index (BMI) ≥17 kg / m2. 7. Minimum interval since last drug therapy: 1. 1 week for…
Interventions
- DeviceNaviFUS System
The NaviFUS System is a FUS phased array system intended to transcranially deliver burst-mode ultrasound energy with the concurrent microbubble intravenous administration to temporally and locally open the BBB. The NaviFUS System is indicated for use to enhance the permeability of conventionally administered therapeutic agents into targeted brain tissue to enhance their therapeutic effects.
- DrugLumason
The NaviFUS System is a FUS phased array system intended to transcranially deliver burst-mode ultrasound energy with the concurrent microbubble intravenous administration to temporally and locally open the BBB.
- DrugBevacizumab
In this proposed clinical investigation, the NaviFUS System will be used in conjunction with BEV in recurrent GBM patients.
Location
- University of Cincinnati Medical CenterCincinnati, Ohio