Registry of Patients With Brain Tumors Treated With STaRT (GammaTiles)
Purpose
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
- Brain Tumor, Recurrent
- Brain Tumor
- Brain Tumor, Primary
- Brain Tumor - Metastatic
- Brain Tumor, Adult: Glioblastoma
- Brain Tumor, Adult Meningioma
Eligibility
- Eligible Ages
- All ages
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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
- 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).
Study Design
- Phase
- Study Type
- Observational [Patient Registry]
- Observational Model
- Cohort
- Time Perspective
- Prospective
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| GammaTile | Patients who have received permanent implants of GammaTile radiation therapy immediately following brain tumor resection. |
|
Recruiting Locations
Kansas City, Kansas 66160
Kushal Shah
More Details
- Status
- Recruiting
- Sponsor
- GT Medical Technologies, Inc.
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.