Table 1.
Clinical Trials Using Focused Ultrasound for Blood–Brain Barrier Opening, Sonodynamic Therapy, and Radiation Sensitization for the Treatment of Glioblastoma
| A. Blood–Brain Barrier Opening Clinical Trials (n = 10) | ||||||
|---|---|---|---|---|---|---|
| Title | ClinicalTrials.gov NCT number | Location (sites) | Enrollment | Device | Status | Drug |
| ExAblate Blood–Brain Barrier Disruption (BBBD) for Planned Surgery in Suspected Infiltrating Glioma | 03322813 | USA | 15 | InSightec ExAblate | Active, not recruiting | None, planned surgical resection |
| Assessment of Safety and Feasibility of ExAblate Blood–Brain Barrier (BBB) Disruption | 03551249 | USA (4) | 20 | InSightec ExAblate | Recruiting | Adjuvant TMZ |
| Assessment of Safety and Feasibility of ExAblate Blood–Brain Barrier (BBB) Disruption for Treatment of Glioma | 03616860 | Canada | 20 | InSightec ExAblate | Recruiting | TMZ maintenance |
| ExAblate Blood–Brain Barrier Disruption for Glioblastoma in Patients Undergoing Standard Chemotherapy | 03712293 | Republic of Korea | 10 | InSightec ExAblate | Recruiting | Adjuvant TMZ |
| Safety and Efficacy of Transient Opening of the Blood–brain Barrier (BBB) With the SonoCloud-9 | 03744026 | USA (2); France (4) | 33 | Carthera SonoCloud-9 | Active, not recruiting | Carboplatin |
| ExAblate Blood–Brain Barrier Disruption for the Treatment of rGBM in Subjects Undergoing Carboplatin Monotherapy | 04417088 | USA (4) | 30 | InSightec ExAblate | Recruiting | Carboplatin |
| ExAblate Blood–Brain Barrier Disruption with Carboplatin for the Treatment of rGBM | 04440358 | Canada (1), South Korea (1) | 50 | InSightec ExAblate | Recruiting | Carboplatin |
| Efficacy and Safety of NaviFUS System add-on Bevacizumab (BEV) in Recurrent GBM Patients | 04446416 | Taiwan (1) | 10 | NaviFUS | Recruiting | Bevacizumab |
| Ultrasound-based Blood–brain Barrier Opening and Albumin-bound Paclitaxel for Recurrent Glioblastoma (SC9/ABX) | 04528680 | USA (1) | 39 | CarThera SonoCloud-9 | Recruiting | Albumin-bound paclitaxel |
| SonoCloud-9 Device for Blood–Brain Barrier Opening in First Line Temozolomide Glioblastoma Patients | 04614493 | Belgium (1), France (5), Switzerland (1) | 66 | CarThera SonoCloud-9 | Recruiting | Adjuvant TMZ |
| B. Sonodynamic Therapy (n = 2) and Radiation Sensitization (n = 1) Clinical Trials | ||||||
|---|---|---|---|---|---|---|
| Title | ClinicalTrials.gov NCT number | Location (sites) | Enrollment | Device | Status | Agent |
| Study of Sonodynamic Therapy in Participants With Recurrent High-Grade Glioma | 04559685 | USA (1) | 30 | Insightec ExAblate | Recruiting | 5-ALA (intravenous) SONALA-001 |
| Sonodynamic Therapy With ExAblate System in Glioblastoma Patients (Sonic ALA) | 04845919 | Italy (1) | 5 | Insightec ExAblate | Not yet recruiting | 5-ALA (oral) |
| Evaluate the Safety and Preliminary Efficacy of the Combination of NaviFUS System with Re-irradiation for rGBM Patients | 04988750 | Taiwan (1) | 8 | NaviFUS | Recruiting | Radiation sensitization |
TMZ, temozolomide