Clinical trial · Observational
Registry of Patients With Brain Tumors Treated With STaRT (GammaTiles)
A Multicenter Observational Study of GammaTile™ Surgically Targeted Radiation Therapy (STaRT) in Intracranial Brain Neoplasms
NCT04427384CI-TRIAL-00118979recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The objectives of this registry study are to evaluate real-world clinical outcomes and patient reported outcomes that measure the effectiveness and safety of STaRT.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain Tumor | Brain Neoplasm | ALIAS | 0.90 |
| Brain Tumor, Adult: Glioblastoma | Brain Neoplasm | ALIAS | 0.85 |
| Brain Tumor, Adult Meningioma | Brain Neoplasm | ALIAS | 0.85 |
| Brain Tumor - Metastatic | Meningioma | PROBABILISTIC | 0.70 |
| Brain Tumor, Primary | Primary Brain Tumor | ONTOLOGY_EXACT | 0.98 |
| Brain Tumor, Recurrent | Brain Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| GammaTile | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- GammaTile
- description
- Patients who have received permanent implants of GammaTile radiation therapy immediately following brain tumor resection.
- interventionNames
- Device: GammaTile
Primary outcomes (3)
- measure
- Surgical Bed-Recurrence Free Survival in Metastatic Tumor Subjects
- timeFrame
- 12 months
- description
- No contrast enhancement in the area of the surgical bed
- measure
- Surgical Bed-Recurrence Free Survival in Meningioma Tumor Subjects
- timeFrame
- 3 years
- description
- No contrast enhancement in the area of the surgical bed
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: 1. Patients who undergo maximum safe resection of intracranial neoplasm(s) AND implantation of GammaTiles. 2. Willing and able to provide informed consent and to participate in all evaluations. Exclusion Criteria: 1. Inability to undergo pre-operative and post-operative imaging for disease and implant assessment. 2. Major medical or psychiatric illness, which, in the investigator's opinion would prevent completion of treatment, ability to complete assessments at the time of enrollment, and/or interfere with follow ups. 3. Subjects who, in the investigator's opinion, are unable to understand the protocol or to give informed consent, have a history of poor cooperation, noncompliance with medical treatment, or difficulty in returning for follow up care. A legally authorized representative may provide consent if the potential subject lacks the capacity to provide consent themselves.
References
Publications (0)
Data not yet available
No reference posted for this study.