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

GT Medical Technologies

Status: Enrolling

Conditions: Brain Tumor, Recurrent; Brain Tumor; Brain Tumor, Adult: Glioblastoma; Brain Tumor, Primary; Brain Tumor - Metastatic; Brain Tumor, Adult Meningioma

Treatments: Device: GammaTile

Study type: Observational

Funder types: Industry

Identifiers

NCT04427384

GTM-101

Details and patient eligibility

About

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.

Full 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.

Enrollment: 600 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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. Lack of English language fluency sufficient to allow for completion of neurocognitive and QOL tests (which are in English).

Trial design

600 participants in 1 patient group

GammaTile

Description:

Patients who have received permanent implants of GammaTile radiation therapy immediately following brain tumor resection.

Treatment:

Device: GammaTile