Biodistribution and radiation dosimetry of the PDGFRβ targeting PET tracer [68Ga]Ga-ATH001
11 affiliations
- 1Molecular Imaging and Medical Physics, Department of Surgical Sciences, Uppsala University, Uppsala, Sweden
- 2Takeda Development Center Americas, Inc, Cambridge, MA USA
- 3Department of Molecular Medicine and Surgery, Karolinska Institutet, Stockholm, Sweden
- 4Department of Nuclear Medicine and Medical Physics, Karolinska University Hospital, Stockholm, Sweden
- 5Department of Oncology and Pathology, Karolinska Institutet, Stockholm, Sweden
- 6Theranostics Trial Center, Karolinska Institutet, Stockholm, Sweden
- 7Antaros Tracer AB, Uppsala, Sweden
- 8Antaros Medical AB, Gothenburg, Sweden
- 9Department of Gastroenterology and Hepatology, Uppsala University Hospital, Uppsala, Sweden
- 10Department of Medical Sciences, Gastroenterology Research Group, Uppsala University, Uppsala, Sweden
- 11Department of Medicinal Chemistry, Science for Life Laboratory, Uppsala University, Dag Hammarskjölds Väg 14 C, 3Tr SE-751 83, Uppsala, Sweden
Abstract
Purpose: [68Ga]Ga-ATH001 is an Affibody molecule targeting PDGFRβ in development as a Positron Emission Tomography (PET) tracer for non-invasive imaging of active fibrosis. Here we present first-in-human [68Ga]Ga-ATH001 biodistribution and radiation dosimetry data.
Methods: Radiation dosimetry of [68Ga]Ga-ATH001 was evaluated in healthy participants (n = 3) and participants with metabolic dysfunction-associated steatohepatitis (MASH) (n = 3). Each participant was intravenously administered ~ 2.5 MBq/kg [68Ga]Ga-ATH001 and imaged by whole-body PET for up to 3 h post-injection. Absorbed dose coefficients and effective doses according to ICRP 103 were calculated using IDAC DOSE 2.1.
Results: The effective dose of [68Ga]Ga-ATH001 was 0.028 ± 0.002 mSv/MBq with kidneys as the dose-limiting organ. Administration of a target dose of 2 MBq/kg would result in a sex-averaged effective dose of 4.1 mSv. Subjects tolerated the tracer administration well.
Conclusion: [68Ga]Ga-ATH001 demonstrates a dosimetry and safety profile that supports further clinical development as a repeatable, non-invasive PET marker of active fibrosis in tissue.
Supplementary Information: The online version contains supplementary material available at https://doi.org/10.1007/s00259-026-08167-9.
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BibTeX
@article{lubberink2026biodistribution,
title = {{Biodistribution and radiation dosimetry of the PDGFRβ targeting PET tracer [68Ga]Ga-ATH001}},
author = {Mark Lubberink and Talakad G. Lohith and Zoltan Derdak and Paul Wilkens and Emilia Palmér and Alexandra Ramolli and Mélodie Ferrat and Thuy A. Tran and Bogdan Mitran and Ayman Abouyzayed and Lars Johansson and Haakan Wennbo and Fredrik Rorsman and Johan Vessby and Olof Eriksson},
journal = {European Journal of Nuclear Medicine and Molecular Imaging},
year = {2026},
month = sep,
doi = {10.1007/s00259-026-08167-9},
url = {https://doi.org/10.1007/s00259-026-08167-9},
note = {CC BY 4.0},
}
RIS
TY - JOUR
TI - Biodistribution and radiation dosimetry of the PDGFRβ targeting PET tracer [68Ga]Ga-ATH001
AU - Mark Lubberink
AU - Talakad G. Lohith
AU - Zoltan Derdak
AU - Paul Wilkens
AU - Emilia Palmér
AU - Alexandra Ramolli
AU - Mélodie Ferrat
AU - Thuy A. Tran
AU - Bogdan Mitran
AU - Ayman Abouyzayed
AU - Lars Johansson
AU - Haakan Wennbo
AU - Fredrik Rorsman
AU - Johan Vessby
AU - Olof Eriksson
PY - 2026
DA - 2026/09/08
JO - European Journal of Nuclear Medicine and Molecular Imaging
DO - 10.1007/s00259-026-08167-9
UR - https://doi.org/10.1007/s00259-026-08167-9
AB - Purpose: [68Ga]Ga-ATH001 is an Affibody molecule targeting PDGFRβ in development as a Positron Emission Tomography (PET) tracer for non-invasive imaging of active fibrosis. Here we present first-in-human [68Ga]Ga-ATH001 biodistribution and radiation dosimetry data. Methods: Radiation dosimetry of [68Ga]Ga-ATH001 was evaluated in healthy participants (n = 3) and participants with metabolic dysfunction-associated steatohepatitis (MASH) (n = 3). Each participant was intravenously administered ~ 2.5 MBq/kg [68Ga]Ga-ATH001 and imaged by whole-body PET for up to 3 h post-injection. Absorbed dose coefficients and effective doses according to ICRP 103 were calculated using IDAC DOSE 2.1. Results: The effective dose of [68Ga]Ga-ATH001 was 0.028 ± 0.002 mSv/MBq with kidneys as the dose-limiting organ. Administration of a target dose of 2 MBq/kg would result in a sex-averaged effective dose of 4.1 mSv. Subjects tolerated the tracer administration well. Conclusion: [68Ga]Ga-ATH001 demonstrates a dosimetry and safety profile that supports further clinical development as a repeatable, non-invasive PET marker of active fibrosis in tissue. Supplementary Information: The online version contains supplementary material available at https://doi.org/10.1007/s00259-026-08167-9.
SN - 1619-7070
SN - 1619-7089
ER -