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

Status
Active
Cancer Type
Brain & Spinal Cord Tumor
Trial Phase
Eligibility
0 Years and older, Male and Female
Study Type
Other
NCT ID
NCT04427384
Protocol IDs
GTM-101 (primary)
NCI-2020-13272
Study Sponsor
GT Medical Technologies, Inc.

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.

Objectives

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.

Eligibility

  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.

Treatment Sites in Georgia

Winship Cancer Institute of Emory University


1365 Clifton Road NE
Building C
Atlanta, GA 30322
404-778-5180
winshipcancer.emory.edu

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Advancing Cancer Care through Partnerships and Innovation

Georgia CORE is a statewide nonprofit that leverages partnerships and innovation to attract more clinical trials, increase research, and promote education and early detection to improve cancer care for Georgians in rural, urban, and suburban communities across the state.