Observational Study of GammaTile Surgically Targeted Radiation Therapy for Patients With Brain Tumors

What this Trial Is About

This observational registry study focuses on patients with brain tumors who have undergone surgical removal of their tumors followed by treatment with STaRT Surgically Targeted Radiation Therapy using GammaTile implants. The study aims to assess real-world clinical outcomes and patient-reported results to measure the effectiveness and safety of this treatment approach delivered by Cs-131 sources in resorbable collagen tile carriers. It is the first study of its kind to collect detailed data on this treatment for brain tumors of any pathology. Participants in the study are those who have had maximum safe surgical resection of intracranial brain tumors and immediately received permanent GammaTile implants as part of their treatment. Data collection occurs at multiple time points 1, 3, 6, 9, 12, 18, and 24 months after treatment, then every 6 months for up to 5 years. This long-term follow-up allows for comparison of clinical results to existing standard care treatments. During the study, researchers will monitor local tumor control, overall survival, quality of life, cognitive function, functional decline, and any surgical or radiation-related adverse events. Imaging before and after surgery will be used to assess disease and implant status. The study will evaluate key outcomes such as surgical bed recurrence-free survival and overall survival in specific tumor subtypes. Participants ongoing health and treatment effects will be observed for up to five years to provide comprehensive safety and effectiveness data.

Registry of Patients With Brain Tumors Treated With STaRT (GammaTiles)