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GliaSite Radiation Therapy System · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | Patients with 1-3 brain metastases |
| Name | Type | Description |
|---|---|---|
| GliaSite Radiation Therapy System | DEVICE | GliaSite RTS is designed to deliver intracavitary radiation therapy for brain tumors. Following surgical resection, the balloon catheter is inflated to fill the cavity and Iotrex radiotherapy solution infused. It is a single applicator system that provides a uniform and conformal dose to the resection cavity. |
Inclusion Criteria: * Have 1-3 newly diagnosed supratentorial metastatic brain lesions with at least one being dominant and eligible for surgical resection as visualized on enhanced MRI scan * Have histological evidence of metastatic carcinoma on intraoperative pathology (frozen section) or final p...
GliaSite Radiation Therapy System is used for brain metastases, which are tumors that have spread to the brain from other parts of the body. It is an investigational device being studied as a potential treatment option for patients with this condition.
GliaSite Radiation Therapy System is developed by Hologic, Inc., a company traded on the NASDAQ under the ticker symbol HOLX. Hologic is the developer of this investigational radiation therapy system for brain metastases.
GliaSite Radiation Therapy System is in Phase 2 clinical development. It is an investigational device, meaning it has not been approved by regulatory authorities and is still being studied in clinical trials to evaluate its safety and effectiveness for treating brain metastases.
GliaSite Radiation Therapy System has one completed clinical trial, the GliaSite 1-3 Mets Study (NCT00589212). This Phase 2 study enrolled 50 participants with brain metastases in the United States. The trial was not randomized or blinded and had no control group.
GliaSite Radiation Therapy System is not FDA approved. It is an investigational device currently in Phase 2 clinical development for brain metastases. The completed clinical trial (NCT00589212) was a Phase 2 study, but approval status has not been established based on available information.