Registry of Patients With Brain Tumors Treated With STaRT (GammaTiles)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: GammaTile.
- Who it may be relevant to
- Registry conditions: Brain Tumor, Recurrent, Brain Tumor, Brain Tumor, Primary, Brain Tumor - Metastatic. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Multicenter Observational Study of GammaTile™ Surgically Targeted Radiation Therapy (STaRT) in Intracranial Brain Neoplasms
Overview
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.
Interventions
- Device GammaTile
Surgically Targeted Radiation Therapy
Primary outcome measures
- Surgical Bed-Recurrence Free Survival in Metastatic Tumor Subjects [Time frame: 12 months]
- Surgical Bed-Recurrence Free Survival in Meningioma Tumor Subjects [Time frame: 3 years]
- Overall Survival in High Grade Glioma Subjects [Time frame: 9 months]
Eligibility criteria
Inclusion criteria
- Patients who undergo maximum safe resection of intracranial neoplasm(s) AND implantation of GammaTiles.
- Willing and able to provide informed consent and to participate in all evaluations.
Exclusion criteria
- Inability to undergo pre-operative and post-operative imaging for disease and implant assessment.
- 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.
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 54 centers
- HonorHeath Scottsdale Osborn Medical Center — Phoenix
- University of Arkansas Medical Center — Little Rock
- Eden Medical Center — Castro Valley
- UCSD Moores Cancer Center — La Jolla
- MemorialCare Health System — Laguna Hills
- Desert Regional Medical Center — Palm Springs
- California Pacific Medical Center, Sutter health — San Francisco
- Centura — Denver
- … and 46 more centers
Identifiers
NCT: NCT04427384 · GTM-101