Feasibility of serial cfDNA measurement after perflubutane microbubble (Sonazoid®) administration in patients with pancreatic ductal adenocarcinoma: a first-in-human pilot study

BACKGROUND: administration in patients with resectable or borderline-resectable PDAC. METHODS: ) were administered intravenously at the standard diagnostic dose (0.015 mL/kg). Blood samples were collected at baseline and at 5, 15, 30, and 60 min after administration. Plasma cfDNA was extracted using a standardized protocol and quantified in duplicate by fluorometric analysis. The primary objective was feasibility, defined as successful completion of serial blood sampling, plasma processing, cfDNA extraction, and quantitative cfDNA measurement, as well as procedural safety. Changes in cfDNA concentration were assessed descriptively as an exploratory outcome. RESULTS: administration were observed. CONCLUSIONS: Serial peri-procedural cfDNA measurement using standardized sampling and fluorometric quantification was feasible and safe in patients with resectable or borderline-resectable PDAC. Administration of perflubutane microbubbles at standard diagnostic doses did not induce a uniform or sustained increase in circulating cfDNA concentrations in this pilot cohort. These findings provide feasibility data and may inform the design of future studies evaluating cfDNA dynamics after clearance-modulating interventions in PDAC. Trial Registration This study is registered in the Japan Registry of Clinical Trials (jRCT) under the identifier jRCTs071240095, registered on January 10, 2025. Registration details are available at: https://jrct.mhlw.go.jp/latest-detail/jRCTs071240095.