RecruitingNCT04427384
Registry of Patients With Brain Tumors Treated With STaRT (GammaTiles)
A Multicenter Observational Study of GammaTile™ Surgically Targeted Radiation Therapy (STaRT) in Intracranial Brain Neoplasms
Sponsor
GT Medical Technologies, Inc.
Enrollment
600 participants
Start Date
Sep 11, 2020
Study Type
OBSERVATIONAL
Conditions
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.
Eligibility
Inclusion Criteria2
- 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 Criteria3
- 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.
Interventions
DEVICEGammaTile
Surgically Targeted Radiation Therapy
Locations(54)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT04427384
Related Trials
The Effects of Intraoperative Tranexamic Acid on Perioperative Bleeding In Craniotomies
NCT062294831 location
Treatment Response Assessment Maps to Delineate Necrosis From Tumor After Stereotactic Radiation in Brain Metastases
NCT040334972 locations
Determining Postoperative Recovery and the Impact of Adverse Events in Neurosurgery Based on Self-reported, App-based Longitudinal Assessment
NCT063527101 location
A Phase I/II Study of Zotiraciclib for Recurrent Malignant Gliomas With Isocitrate Dehydrogenase 1 or 2 (IDH1 or IDH2) Mutations
NCT055881411 location
Clinical, patHOlogical and Imaging Project of nEuro-oncology (HOPE)
NCT058596591 location