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

Active:	Yes
Cancer Type:	Brain & Spinal Cord Tumor	NCT ID:	NCT04427384
Trial Phases:		Protocol IDs:	GTM-101 (primary) NCI-2020-13272
Eligibility:	0 Years and older, Male and Female	Study Type:	Other
Study Sponsor:	GT Medical Technologies, Inc.
NCI Full Details:	http://clinicaltrials.gov/show/NCT04427384

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.

Treatment Sites in Georgia

Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
winshipcancer.emory.edu

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