Abstract C097: Evolution of global radiopharmaceutical clinical trials in oncology: A data-driven analysis of historical and current trends

Abstract Background: The use of radiopharmaceuticals in oncology has seen a rapid growth of interest and investment. Driven by the need for a comprehensive overview of this rapidly expanding field, we conducted a study to characterize the evolution of oncology clinical trials involving radiopharmaceuticals and to identify the key areas of present-day research interest. Materials and Methods: We collected global oncology clinical trial data from clinicaltrials.gov, ISRCTN, and ANZCTR. This dataset was then analyzed using a specialized AI model to systematically extract information on radiopharmaceuticals, radioisotopes, and radiation types mentioned within each trial. We evaluated historical trends by mapping the number of trials over time based on their initial posting date. To supplement this analysis, we also characterized current user interest by analyzing data from a global radiopharmaceutical trial finder tool. Results: Between January 1, 2005, and December 31, 2024, a total of 3,751 oncology trials involving radiopharmaceuticals were posted across three registries: Clinicaltrials.gov, ISRCTN and ANZCTR. There was a 619% increase in trials listed between 2005 (n=57) and 2024 (n=410). Of all trials, 86.3% (n=3,238) were sponsored by academic institutions, while 13.7% (n=513) were industry-sponsored. Positron radioisotopes were most prevalent, involved in 69.6% (n=2,611) of trials, followed by beta 19.3% (n=725), gamma 11.9% (n=448), and alpha 5.4% (n=204) emitting radioisotopes. The top 3 radioisotopes involved in clinical trials over this period included F-18 (n=1,804), Ga-68 (N=531) and Lu-177 (n=308). Over a five-year period, the number of industry-sponsored trials experienced a nearly two-fold increase, from 31 in 2020 to 58 in 2024. During this timeframe, trials involving therapeutic radiopharmaceuticals saw a notable increase, from 69 to 120, representing a 74% growth. Meanwhile, diagnostic-only trials grew from 205 to 290, a 41% increase. Analysis of a public, global radiopharmaceutical trial finder tool usage data reflected 19,815 unique visitors from 48 countries between October 16, 2024, to September 10, 2025. User searches for radiopharmaceuticals were dominated by therapeutic isotopes and targets. The most-searched radioisotopes were Ac-225 (n=123), Lu-177 (n=73), and Pb-212 (n=61), and top targets searched for included PSMA (n=27), FAP (n=20), and HER2 (n=18). Conclusion: Our analysis reveals a significant and sustained increase in oncology trials involving radiopharmaceuticals, particularly in the last five years, with a notable surge in industry sponsored trials and therapeutic trials. While historical trial data is dominated by diagnostic isotopes such as F-18 and Ga-68, the current usage data from a global trial finder tool shows a strong interest in therapeutic radioisotopes (e.g., Ac-225, Lu-177) and specific targets such as PSMA and FAP. This growth and evolving interest suggest a dynamic future for the field, underscoring its pivotal role in the advancement of precision medicine and personalized cancer therapeutics. Citation Format: Andrei Iagaru MD, Josh Mailman, Danielle Ralic. Evolution of global radiopharmaceutical clinical trials in oncology: A data-driven analysis of historical and current trends [abstract]. In: Proceedings of the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics; 2025 Oct 22-26; Boston, MA. Philadelphia (PA): AACR; Mol Cancer Ther 2025;24(10 Suppl):Abstract nr C097.