First-in-human dosimetry and biodistribution of [89Zr]Zr-oxine-labeled autologous leukocytes using PET/CT
5 affiliations
- 1Department of Biomedical Engineering, University of Alabama at Birmingham, Birmingham, AL 35294 USA
- 2Department of Radiology, University of Alabama at Birmingham, Birmingham, AL 35294 USA
- 3Department of Radiation Oncology, University of Alabama at Birmingham, Birmingham, AL USA
- 4Department of Psychology, University of Alabama at Birmingham, Birmingham, AL USA
- 5Department of Psychiatry and Behavioral Neurobiology, University of Alabama at Birmingham, Birmingham, AL USA
Abstract
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.
Graphical Abstract:
Supplementary Information: The online version contains supplementary material available at https://doi.org/10.1007/s00259-026-08158-w.
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BibTeX
@article{gultekin2026firstinhuman,
title = {{First-in-human dosimetry and biodistribution of [89Zr]Zr-oxine-labeled autologous leukocytes using PET/CT}},
author = {Kadir Gultekin and Jennifer L. Bartels and Carlos E. Cardenas and Yogesh Kumar and Grayson R. Gimblet and Chloe L. Jones and Christina Bankston and Charlotte D. Jeffers and Sharon L. White and Suzanne E. Lapi and Jarred W. Younger and Jonathan E. McConathy},
journal = {European Journal of Nuclear Medicine and Molecular Imaging},
year = {2026},
month = oct,
doi = {10.1007/s00259-026-08158-w},
url = {https://doi.org/10.1007/s00259-026-08158-w},
note = {CC BY 4.0},
}
RIS
TY - JOUR
TI - First-in-human dosimetry and biodistribution of [89Zr]Zr-oxine-labeled autologous leukocytes using PET/CT
AU - Kadir Gultekin
AU - Jennifer L. Bartels
AU - Carlos E. Cardenas
AU - Yogesh Kumar
AU - Grayson R. Gimblet
AU - Chloe L. Jones
AU - Christina Bankston
AU - Charlotte D. Jeffers
AU - Sharon L. White
AU - Suzanne E. Lapi
AU - Jarred W. Younger
AU - Jonathan E. McConathy
PY - 2026
DA - 2026/10/02
JO - European Journal of Nuclear Medicine and Molecular Imaging
DO - 10.1007/s00259-026-08158-w
UR - https://doi.org/10.1007/s00259-026-08158-w
AB - 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. Graphical Abstract: Supplementary Information: The online version contains supplementary material available at https://doi.org/10.1007/s00259-026-08158-w.
SN - 1619-7070
SN - 1619-7089
ER -