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Enhancing USP Compliance in Transarterial Radioembolization Using 90Y Resin Microspheres
Xingyu Nie1, Kimyli Lemieux2, William Denton1
1University of Kentucky, Lexington, Kentucky.
Abstract:
USP <825> mandates 1-h beyond-use date (BUD) for immediate-use radiopharmaceuticals, posing workflow challenges for complex transarterial radioembolization procedures using 90Y-labeled resin microspheres (90Y-RM). To enhance compliance and patient safety, our institution transitioned 90Y-RM dose preparation from an in-house process to a local commercial nuclear pharmacy, enabling a BUD of up to 96 h. We retrospectively reviewed 120 cases of 90Y-RM preparation and administration. In the old workflow (n = 55), the median time from dose preparation to administration readiness was 49.1 min (interquartile range, 42.0-69.5 min), with 25.5% of doses exceeding the BUD limit. No BUD violations occurred after the new workflow (n = 65) was implemented. The absolute deviation between prescribed and administered activities significantly decreased from 4.3% ± 3.1% to 2.2% ± 2.1% (P < 0.001), with a comparable percentage of administered activity (median, 98.4% vs. 98.6%; P = 0.190). The new workflow effectively achieved USP <825> compliance.

