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
Year: 2024
Type: article
Study design: Observational Study
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.
Source: Neuro-Oncology
Authors: Erin Dunbar, Stuart Lee, Matthew Sean Peach, John Wanbo, Chris Smith, Simon Hansfit, Keith Mertitz, Aviva Berkowitz, Lindsey Sloan, Clara Ferreira, Elizabeth Neil, Rupesh Kotecha, Adam Nowlan, David McCracken, Toral Patel, Zabi Wardak, Angela Richardson, Mitesh Shah, Sajeel Chowdhary, Vincent DiNapoli, John Floyd, Mahmoud Nagib, Andrea Wasilewski, Akash Patel, Ganash Rao, Houng Pham, Roby Ryan, Colette Shen, Adam Robin, Ian Lee, Lewis Leng, Kim Hoang, Jeff Olson, Ondrej Choutka, Catherine Mercado, Rouboz Chamoun, Paul Camarata, William Smith, Harish Babu, David Piccioni, Parag Sevak, James Zhu, Devon Haydon, Michelle Aizenberg, Mark Hoeprich, Brian Williams, Lawrence Dickinson, David Baskin, Andrew Farach, alaniz rodriguez
Institutions: Piedmont Atlanta Hospital, Piedmont Cancer Institute, East Carolina University, University of Minnesota, Baptist Hospital of Miami, The University of Texas Southwestern Medical Center, Indiana University, Tampa General Hospital, Mayfield Brain & Spine, Abbott Northwestern Hospital, University of North Carolina at Chapel Hill, Henry Ford Health, Sutter Health, Emory University, Orlando Health, University of Kansas Medical Center, State University of New York, University of California San Diego, Norton Healthcare, Texas Oncology, BayCare Health System, University of Nebraska at Omaha, University of Louisville, Houston Methodist, University of Arkansas Medical Center, University of Arkansas for Medical Sciences
Language: English
Subfield: Genetics
Field: Medicine
Domain: Health Sciences
Open Access status: green
OpenAlex ID: W4404230933