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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00589212 | GliaSite 1-3 Mets Study | PHASE2 | COMPLETED | 50 | — | — | Oct 1, 2003 | Mar 1, 2008 | Jun 11, 2008 | 1 | United States |
| 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...