A Multicenter Observational Study of GammaTile™ Surgically Targeted Radiation Therapy (STaRT) in Intracranial Brain Neoplasms

  • STATUS
    Recruiting
  • End date
    Dec 31, 2028
  • participants needed
    600
  • sponsor
    GT Medical Technologies, Inc.
Updated on 14 October 2022

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.

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.

Details
Condition Brain Tumor, Recurrent, Brain Tumor, Brain Tumor, Primary, Brain Tumor - Metastatic, Brain Tumor, Adult: Glioblastoma, Brain Tumor, Adult Meningioma
Treatment GammaTile
Clinical Study IdentifierNCT04427384
SponsorGT Medical Technologies, Inc.
Last Modified on14 October 2022

Eligibility

Yes No Not Sure

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
Lack of English language fluency sufficient to allow for completion of neurocognitive and QOL tests (which are in English)
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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