Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
TheraSphere GBM · 1 trial · 2 indications
| 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 ...
TheraSphere GBM is an investigational device being studied for use in patients with recurrent glioblastoma multiforme (GBM), a type of brain cancer. It is currently in Phase 1 clinical development and is not yet approved by the FDA. The device is being evaluated for safety in a feasibility study.
TheraSphere GBM is developed by Boston Scientific Corporation, a publicly traded company listed on the New York Stock Exchange under the ticker symbol BSX. The company is conducting a Phase 1 clinical trial to evaluate the safety of the device in patients with recurrent glioblastoma multiforme.
TheraSphere GBM is in Phase 1 clinical development. It is an investigational device and has not been approved by the FDA. The ongoing Phase 1 trial is a feasibility study designed to evaluate the safety of the device in patients with recurrent glioblastoma multiforme.
TheraSphere GBM is being studied in a Phase 1 clinical trial with the identifier NCT05303467. The trial is titled 'A Feasibility Study to Evaluate the Safety of the TheraSphere Glioblastoma (GBM) Device in Patients With Recurrent GBM' and is currently recruiting participants in the United States.
TheraSphere GBM is not FDA approved. It is an investigational device currently in Phase 1 clinical development. The ongoing clinical trial is a feasibility study to evaluate its safety in patients with recurrent glioblastoma multiforme, and it has not yet completed the clinical development process required for regulatory approval.