First-in-human dosimetry and biodistribution of [ 89 Zr]Zr-oxine-labeled autologous leukocytes using PET/CT.
Kadir Gultekin, Jennifer L Bartels, Carlos E Cardenas et al.
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In 30 seconds
This prospective first-in-human clinical trial evaluated the safety, biodistribution and radiation dosimetry of [89Zr]Zr-oxine-labeled autologous leukocytes in four healthy adult women. Participants received labeled cells and underwent serial whole-body PET/CT imaging over 72 hours. Administration was well tolerated, and imaging visualized leukocyte distribution and its temporal dynamics. The mean effective-dose coefficient was 0.92 ± 0.06 mSv/MBq, numerically below the predicted 1.14 mSv/MBq for [111In]In-oxine-labeled leukocytes in adult females (P = 0.006). The authors conclude that the approach has favorable dosimetry and supports further clinical and research evaluation.
Key findings
- Administration was well tolerated in all four healthy female participants.
- The mean effective-dose coefficient was 0.92 ± 0.06 mSv/MBq, versus a predicted 1.14 mSv/MBq for [111In]In-oxine-labeled leukocytes (P = 0.006).
- The highest mean absorbed-dose coefficients were in the spleen (3.52 ± 1.38 mGy/MBq) and liver (2.1 ± 0.45 mGy/MBq).
- PET/CT visualized leukocyte distribution and temporal dynamics.
Why it matters
PET tracking of labeled leukocytes could support imaging of infection and inflammation and monitoring of cell-based therapies. These initial human data provide estimates of radiation exposure and show that leukocyte distribution can be followed over time with [89Zr]Zr-oxine PET/CT, informing further evaluation of this imaging approach.
What to keep in mind
The study included only four healthy female participants, limiting the generalizability of its safety and dosimetry estimates to patients and other populations.