Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05303467 | A Feasibility Study to Evaluate the Safety of the TheraSphere Glioblastoma (GBM) Device in Patients With Recurrent GBM | PHASE1 | RECRUITING | 36 | — | — | Jul 30, 2022 | Jan 31, 2027 | Jun 1, 2026 | 9 | United States |
| Arm | Type | Description |
|---|---|---|
| Treatment Group A | EXPERIMENTAL | Subjects in which the perfused volume encompasses the non-dominant hemisphere and non-eloquent regions of the brain. The projected radiation absorbed dose to the treatment volume is 40 Gy ±10%. |
| Treatment Group B | EXPERIMENTAL | Subjects in which the perfused volume encompasses the non-dominant hemisphere and eloquent regions of the brain. The projected radiation absorbed dose to the treatment volume is 40 Gy ±10%. |
| Treatment Group C | EXPERIMENTAL | Subjects in which the perfused volume encompasses the dominant hemisphere and non-eloquent regions of the brain. The projected radiation absorbed dose to the treatment volume is 40 Gy ±10%. |
| Treatment Group D | EXPERIMENTAL | Subjects in which the perfused volume encompasses the dominant hemisphere and eloquent regions of the brain. The projected radiation absorbed dose to the treatment volume is 40 Gy ±10%. |
| Name | Type | Description |
|---|---|---|
| TheraSphere GBM | DEVICE | Single treatment of TheraSphere GBM device |
Inclusion Criteria: 1. Subject is 18 years or older and has signed and dated the trial informed consent form (ICF) 2. Life expectancy ≥ 12 weeks 3. Subject is willing and able to comply with the trial testing, procedures, and follow-up schedule 4. History of a histologically confirmed diagnosis of ...