NCT04427384

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 600 (estimated)
• Sponsor: GT Medical Technologies, Inc. · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Patients (N=600) with surgically resected (R) brain tumors of any pathology who have undergone STaRT are eligible. Data collected will include local control, overall survival, QOL, neurocognition, functional decline, and surgical and radiation associated AE's. Data will be collected at 1, 3, 6, 9,12, 18 and 24 months, then every 6 months through 5 years. RESULT: Data will be used to benchmark clinical outcomes of STaRT therapy and allow for comparisons to existing standard-of-care treatments. This will be the first observational registry study of R+STaRT, delivered by Cs-131 sources in permanently implanted resorbable collagen tile carriers. The outcome measures captured will allow for evaluation of the potential risks and benefits of this treatment approach for patients in a real-world setting.

Conditions

• Brain Tumor, Recurrent
• Brain Tumor
• Brain Tumor, Primary
• Brain Tumor - Metastatic
• Brain Tumor, Adult: Glioblastoma
• Brain Tumor, Adult Meningioma

Interventions

Type	Name	Description
DEVICE	GammaTile	Surgically Targeted Radiation Therapy

Timeline

• Start date: 2020-09-11
• Primary completion: 2028-10-31
• Completion: 2028-12-31
• First posted: 2020-06-11
• Last updated: 2026-02-13

Locations

54 sites across 1 country: United States

Regulatory

• FDA-regulated device study