Status:
RECRUITING
Registry of Patients With Brain Tumors Treated With STaRT (GammaTiles)
Lead Sponsor:
GT Medical Technologies, Inc.
Conditions:
Brain Tumor, Recurrent
Brain Tumor
Eligibility:
All Genders
Brief 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, fun...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 11 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2028
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT04427384
Start Date
September 11 2020
End Date
December 31 2028
Last Update
January 7 2026
Active Locations (53)
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1
HonorHeath Scottsdale Osborn Medical Center
Phoenix, Arizona, United States, 85027
2
University of Arkansas Medical Center
Little Rock, Arkansas, United States, 72205
3
Eden Medical Center
Castro Valley, California, United States, 94546
4
UCSD Moores Cancer Center
La Jolla, California, United States, 92093