European journal of nuclear medicine and molecular imaging · 2026
First-in-human dosimetry and biodistribution of [89Zr]Zr-oxine-labeled autologous leukocytes using PET/CT.
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Gultekin Kadir, Bartels Jennifer L, Cardenas Carlos E, Kumar Yogesh, Gimblet Grayson R, Jones Chloe L, Bankston Christina, Jeffers Charlotte D, White Sharon L, Lapi Suzanne E, Younger Jarred W, McConathy Jonathan E
Аннотация
PURPOSE: Cell tracking with zirconium-89 PET has the potential for widespread clinical and research applications, including imaging infection and inflammation and tracking cell-based therapies. This prospective first-in-human clinical trial assessed the dosimetry and safety profile of [89Zr]Zr-oxine-labeled autologous leukocytes in healthy female participants.
METHODS: Four healthy adult female participants (ages 37-53) received 10.9 ± 2.9 MBq of [89Zr]Zr-oxine-labeled autologous leukocytes and underwent whole-body PET/CT imaging at five time points (0, 4, 24, 48, and 72 h). Regions of interest were automatically segmented on CT using a machine learning-based approach and manually refined. Time-integrated activity coefficients were calculated using Simpson's rule, with physical decay assumed beyond the final time point. Mean absorbed-dose and effective-dose coefficients were estimated using OLINDA 2.1.
RESULTS: Administration was well-tolerated among all participants. The highest mean absorbed-dose coefficients (mGy/MBq) with standard deviation were observed in the spleen (3.52 ± 1.38), liver (2.1 ± 0.45), adrenals (1.62 ± 0.24), uterus (1.48 ± 0.98), and kidneys (1.36 ± 0.12). The mean effective-dose coefficient was 0.92 ± 0.06 mSv/MBq, numerically lower than the predicted value of 1.14 mSv/MBq based on the distribution of [111In]In-oxine-labeled leukocytes in adult females (P = 0.006, one-sample t-test). The use of [89Zr]Zr-oxine-labeled leukocytes enabled the visualization of leukocyte distribution and temporal dynamics.
CONCLUSION: This study demonstrates the safety and favorable dosimetry of [89Zr]Zr-oxine-labeled leukocytes in healthy humans. These results support the further use of this approach for imaging autologous leukocytes using PET in a range of clinical and research settings.
TRIAL REGISTRATION: ClinicalTrials.gov NCT03807973. Registered January 16, 2019.
METHODS: Four healthy adult female participants (ages 37-53) received 10.9 ± 2.9 MBq of [89Zr]Zr-oxine-labeled autologous leukocytes and underwent whole-body PET/CT imaging at five time points (0, 4, 24, 48, and 72 h). Regions of interest were automatically segmented on CT using a machine learning-based approach and manually refined. Time-integrated activity coefficients were calculated using Simpson's rule, with physical decay assumed beyond the final time point. Mean absorbed-dose and effective-dose coefficients were estimated using OLINDA 2.1.
RESULTS: Administration was well-tolerated among all participants. The highest mean absorbed-dose coefficients (mGy/MBq) with standard deviation were observed in the spleen (3.52 ± 1.38), liver (2.1 ± 0.45), adrenals (1.62 ± 0.24), uterus (1.48 ± 0.98), and kidneys (1.36 ± 0.12). The mean effective-dose coefficient was 0.92 ± 0.06 mSv/MBq, numerically lower than the predicted value of 1.14 mSv/MBq based on the distribution of [111In]In-oxine-labeled leukocytes in adult females (P = 0.006, one-sample t-test). The use of [89Zr]Zr-oxine-labeled leukocytes enabled the visualization of leukocyte distribution and temporal dynamics.
CONCLUSION: This study demonstrates the safety and favorable dosimetry of [89Zr]Zr-oxine-labeled leukocytes in healthy humans. These results support the further use of this approach for imaging autologous leukocytes using PET in a range of clinical and research settings.
TRIAL REGISTRATION: ClinicalTrials.gov NCT03807973. Registered January 16, 2019.