Biodistribution and Radiation Dosimetry of [ <sup>68</sup> Ga]Ga-RAYZ-8009, a Glypican 3–Targeting Compound for Imaging of Hepatocellular Carcinoma

Glypican 3 is highly expressed in hepatocellular carcinoma (HCC), rendering it a promising target for disease imaging. [<sup>68</sup>Ga]Ga-RAYZ-8009 is a recently introduced PET tracer selective for glypican 3. To further assess the safety and suitability of this radiopharmaceutical in a clinical setting, whole-body distribution and radiation dosimetry were evaluated. <b>Methods:</b> Six patients with histologically confirmed HCC or clinical or imaging-based suspicion of HCC were intravenously injected with 103-167 MBq of [<sup>68</sup>Ga]Ga-RAYZ-8009 (mean ± SD, 150 ± 22 MBq). Whole-body PET/CT scans were acquired at 10 min, 1 h, 2 h, 4 h, and 7 h after tracer injection. Time-activity curves per organ were determined, and mean organ-absorbed doses and effective doses were calculated using IDAC-Dose 2.1. <b>Results:</b> Injection of a standard activity of 150 MBq of [<sup>68</sup>Ga]Ga-RAYZ-8009 resulted in a median effective dose of 3.6 mSv for the male reference phantom. The highest absorbed organ doses were observed in the kidneys (median of 0.175 mGy/MBq and 0.179 mGy/MBq for male and female reference phantom, respectively), followed by the red bone marrow (median of 0.044 mGy/MBq for male/female reference phantom) and the stomach wall (median of 0.060 and 0.062 mGy/MBq for male and female reference phantom, respectively). <b>Conclusion:</b> [<sup>68</sup>Ga]Ga-RAYZ-8009 demonstrates a favorable biodistribution and dosimetry in patients with HCC.

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Journal
Journal of Nuclear Medicine
Published
2025-09-25
DOI
https://doi.org/10.2967/jnumed.125.270267
Primary Topic
Radiopharmaceutical Chemistry and Applications
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article
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article

Biodistribution and Radiation Dosimetry of [ 68 Ga]Ga-RAYZ-8009, a Glypican 3–Targeting Compound for Imaging of Hepatocellular Carcinoma

Julia Brosch-Lenz, Ralph A. Bundschuh, Georgine Wienand, Adriana Amerein et al.
Journal of Nuclear Medicine
Radiopharmaceutical Chemistry and Applications
article

Biodistribution and Radiation Dosimetry of [ 68 Ga]Ga-RAYZ-8009, a Glypican 3–Targeting Compound for Imaging of Hepatocellular Carcinoma

Julia Brosch-Lenz, Ralph A. Bundschuh, Georgine Wienand, Adriana Amerein, Marianne Patt, Malte Kircher, Oliver Viering, Johanna S. Enke, Constantin Lapa, Christian H. Pfob, Alexander Dierks, Helen Scholtissek
article en

Abstract

Glypican 3 is highly expressed in hepatocellular carcinoma (HCC), rendering it a promising target for disease imaging. [<sup>68</sup>Ga]Ga-RAYZ-8009 is a recently introduced PET tracer selective for glypican 3. To further assess the safety and suitability of this radiopharmaceutical in a clinical setting, whole-body distribution and radiation dosimetry were evaluated. <b>Methods:</b> Six patients with histologically confirmed HCC or clinical or imaging-based suspicion of HCC were intravenously injected with 103-167 MBq of [<sup>68</sup>Ga]Ga-RAYZ-8009 (mean ± SD, 150 ± 22 MBq). Whole-body PET/CT scans were acquired at 10 min, 1 h, 2 h, 4 h, and 7 h after tracer injection. Time-activity curves per organ were determined, and mean organ-absorbed doses and effective doses were calculated using IDAC-Dose 2.1. <b>Results:</b> Injection of a standard activity of 150 MBq of [<sup>68</sup>Ga]Ga-RAYZ-8009 resulted in a median effective dose of 3.6 mSv for the male reference phantom. The highest absorbed organ doses were observed in the kidneys (median of 0.175 mGy/MBq and 0.179 mGy/MBq for male and female reference phantom, respectively), followed by the red bone marrow (median of 0.044 mGy/MBq for male/female reference phantom) and the stomach wall (median of 0.060 and 0.062 mGy/MBq for male and female reference phantom, respectively). <b>Conclusion:</b> [<sup>68</sup>Ga]Ga-RAYZ-8009 demonstrates a favorable biodistribution and dosimetry in patients with HCC.

Journal of Nuclear MedicineVol. 66(11)
University of Augsburg (DE), German Cancer Research Center (DE), Helmholtz-Zentrum Dresden-Rossendorf (DE), National Institute of Mental Health (US), University Hospital Carl Gustav Carus (DE), Deutsches Konsortium für Translationale Krebsforschung (DE)
Openalex Percentile: Top 61%
Radiopharmaceutical Chemistry and Applications
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