CTNI-75. TRIALS IN PROGRESS: REGISTRY OF SAFETY & EFFICACY IN ADULTS WITH PRIMARY & METASTATIC INTRACRANIAL TUMORS TREATED WITH START (GAMMATILES (CS-131 SOURCE BRACHY-THERAPY)): NCT04427384
Abstract INTRO This is the first observational registry study of R+STaRT, delivered by Cs-131 sources in permanently implanted resorbable collagen tile carriers, for patients with intracranial tumors. METHODS Since October 2020, 37 sites to-date have enrolled 359 patients with primary & metastatic intracranial tumors into the R+STaRT registry to assess the safety & efficacy of the addition of Gamma Tile to medically needed resection. Local control, overall survival, QOL, neurocognition, functional decline, and surgical and radiation associated AE’s are collected at 1, 3, 6, 9,12, 18 and 24 months, then every 6 months through 5 years. RESULTS Demographics include 359 patients, avg. age 57 y.o.. 162 malignant gliomas, 125 metastatic tumors, 38 meningiomas, and 34 rare other tumors. 197 Males (163 White, 23 Black, 5 Asian, and other races) and 157 Females (White 121, 28 Black, 0 Asian, and 8 other races). No unexpected outcomes reported in the hands of experienced providers have occurred, although close clinical-radiographic follow-up, to ensure early detection of possible treatment-effects, is paramount. Steroid-use, and above endpoints, continue to be collected. CONCLUSIONS In this observational registry of Gamma Tiles (Cs-131 source brachy-therapy) added to medically needed resections for patients with primary and metastatic intracranial tumors continues. Data will be used to benchmark clinical outcomes of R+STaRT therapy and allow for comparisons to existing standard-of-care treatments. 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.
Authors
- Mitesh V. Shah (ORCID: https://orcid.org/0000-0001-7569-6709)
- Sajeel Chowdhary
- Toral Patel (ORCID: https://orcid.org/0000-0002-8558-7407)
- Clara Ferreira (ORCID: https://orcid.org/0000-0002-3358-6509)
- Aviva Berkowitz (ORCID: https://orcid.org/0000-0003-1687-2500)
- Brian J. Williams (ORCID: https://orcid.org/0000-0002-3465-4972)
- Stuart Lee (ORCID: https://orcid.org/0000-0002-5071-7443)
- Mark Hoeprich
- Rupesh Kotecha (ORCID: https://orcid.org/0000-0001-6927-0402)
- Mahmoud G. Nagib
- Catherine E. Mercado (ORCID: https://orcid.org/0009-0002-8666-5814)
- Andrew Farach (ORCID: https://orcid.org/0000-0002-9982-4557)
- Elizabeth R. Neil
- Robert J. Ryan (ORCID: https://orcid.org/0000-0001-6505-2694)
- Lindsey Sloan (ORCID: https://orcid.org/0000-0002-1904-8376)
- Louise Dickinson (ORCID: https://orcid.org/0009-0009-5703-5742)
- Gaofeng Rao (ORCID: https://orcid.org/0000-0002-5472-3170)
- Ondrej Choutka (ORCID: https://orcid.org/0000-0002-7561-1549)
- Andrea Wasilewski (ORCID: https://orcid.org/0000-0001-6973-1651)
- Parag Sevak
- David J. McCracken (ORCID: https://orcid.org/0000-0002-8278-478X)
- Adam Robin (ORCID: https://orcid.org/0000-0003-4285-2722)
- Roukoz Chamoun (ORCID: https://orcid.org/0000-0002-1479-0352)
- Harish Babu (ORCID: https://orcid.org/0000-0002-9837-6318)
- Vincent DiNapoli
- Adam Nowlan
- Devon H. Haydon
- David Piccioni (ORCID: https://orcid.org/0000-0001-6006-0126)
- Paul J. Camarata (ORCID: https://orcid.org/0000-0003-4556-2763)
- Matthew Sean Peach (ORCID: https://orcid.org/0000-0002-6877-6919)
- James Zhu (ORCID: https://orcid.org/0000-0003-2713-1839)
- Angela Mae Richardson (ORCID: https://orcid.org/0000-0003-2656-7438)
- Huong Thi-Thu Pham (ORCID: https://orcid.org/0000-0001-5276-7455)
- Zabi Wardak (ORCID: https://orcid.org/0000-0001-9007-8415)
- Angel Rodriguez (ORCID: https://orcid.org/0000-0003-0735-3039)
- Chris Smith (ORCID: https://orcid.org/0000-0003-1808-6570)
- Colette Shen
- Akash R. Patel (ORCID: https://orcid.org/0000-0002-8587-4780)
- Ian Lee (ORCID: https://orcid.org/0000-0001-6057-7176)
- Lewis Z. Leng
- William Smith
- Erin Dunbar
- Jeff Olson
- Kim Hoang
- Michelle Aizenberg
- David S. Baskin (ORCID: https://orcid.org/0000-0002-8076-382X)
- John Floyd
- John Wanbo
- Simon Hansfit
- Keith Mertitz
Institutions
- University of North Carolina at Chapel Hill (US)
- Sutter Health (US)
- University of Nebraska at Omaha (US)
- Houston Methodist (US)
- Virginia Mason Medical Center (US)
- Abbott Northwestern Hospital (US)
- University of North Carolina Health Care (US)
- University of Indianapolis (US)
- Orlando Health (US)
- Emory and Henry College (US)
- Norton Healthcare (US)
- Vatterott College (US)
- Texas Oncology (US)
- Urology San Antonio (US)
- Phoenix (Italy) (IT)
- Shenandoah Oncology (US)
- Piedmont Cancer Institute (US)
- BayCare Health System (US)
- Baylor School (US)
- Mayfield Brain & Spine (US)
- University of Louisville Hospital (US)
- Indiana University (US)
- Syracuse University (US)
- The University of Texas Southwestern Medical Center (US)
Publication Details
- Journal
- Neuro-Oncology
- Published
- 2024-11-01
- DOI
- https://doi.org/10.1093/neuonc/noae165.0442
- Primary Topic
- Management of metastatic bone disease
- Type
- article
- Field-Weighted Citation Impact
- 0.00