Preclinical evaluation of DOTAGA.Glu.(FAPI)2 and DO3A.Glu.(FAPI)2 as theranostics with human dosimetry extrapolation to lutetium-177 and terbium-161 analogs.

Purpose: This study aims to assess DOTAGA.Glu.(FAPI)2 and DO3A.Glu.(FAPI)2, specifically engineered as precursors for the development of theranostic FAPI-targeted radioligands. Methods: DOTAGA.Glu.(FAPI)2 and DO3A.Glu.(FAPI)2 were radiolabeled with gallium-68 and lutetium-177, followed by in vitro (...

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Publicado en:European Journal of Nuclear Medicine & Molecular Imaging Vol. 53; no. 3; pp. 1887 - 1902
Autores principales: Bilinska, Adrianna, Kumar, Naveen, Gnesin, Silvano, Läppchen, Tilman, Menéndez, Elena, Martin, Marcel, Rösch, Frank, Rominger, Axel, Gourni, Eleni
Formato: Journal Article
Publicado: Springer Nature Feb2026
Acceso en línea:Ver este registro en EBSCOhost
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      dt: Feb2026
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      pub: Springer Nature
      place: New York, New York
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        188704295
        10.1007/s00259-025-07565-9
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        atl: Preclinical evaluation of DOTAGA.Glu.(FAPI)2 and DO3A.Glu.(FAPI)2 as theranostics with human dosimetry extrapolation to lutetium-177 and terbium-161 analogs.
      aug:
        au:
          Bilinska, Adrianna
          Kumar, Naveen
          Gnesin, Silvano
          Läppchen, Tilman
          Menéndez, Elena
          Martin, Marcel
          Rösch, Frank
          Rominger, Axel
          Gourni, Eleni
        affil: https://ror.org/01q9sj412 Department of Nuclear Medicine, Inselspital, Bern University Hospital, Bern, Switzerland
      sug:
      ab: Purpose: This study aims to assess DOTAGA.Glu.(FAPI)2 and DO3A.Glu.(FAPI)2, specifically engineered as precursors for the development of theranostic FAPI-targeted radioligands. Methods: DOTAGA.Glu.(FAPI)2 and DO3A.Glu.(FAPI)2 were radiolabeled with gallium-68 and lutetium-177, followed by in vitro (lipophilicity, protein binding, saturation, internalization and externalization) studies on FAP+ CAFs. In vivo (biodistribution, metabolic stability, blood kinetics, PET/SPECT/CT imaging) and ex vivo, (autoradiography, immunohistochemistry) conducted on PC3-mice. Murine dosimetry data were extrapolated to human estimates. Results: All radioligands achievied > 98% radiochemical purity, demonstrating high FAP affinity (Kd:0.7–0.9 nM) and rapid internalization in CAFs, with differences in lipophilicity and serum protein binding. In vivo studies, for [68Ga]Ga-DOTAGA.Glu.(FAPI)2 and [68Ga]Ga-DO3A.Glu.(FAPI)2 showed high and sustained tumor uptake up to 3 h p.i. (18–19%I.A./g). For [177Lu]Lu-DOTAGA.Glu.(FAPI)2 and [177Lu]Lu-DO3A.Glu.(FAPI)2 tumor uptake was 16.2 ± 2.5 and 15 ± 1.2% IA/g at 4 h p.i., reaching 5.1 ± 0.1 and 2.8 ± 0.4%IA/g at 48 h, respectively. All radioligands exhibited low blood retention levels. PET/SPECT/CT imaging confirmed high tumor-to-background ratios. Uptake patterns correlate well with autoradiography images of heterogeneous FAP distribution in PC3-mice, while the detection of both murine and human FAP in PC3-tumors was demonstrated through immunohistochemistry. The extrapolated human absorbed dose estimates (Gy/GBq) for [177Lu]Lu-DOTAGA.Glu.(FAPI)2 were generally higher across most organs compared to [177Lu]Lu-DO3A.Glu.(FAPI)2. Human extrapolation of the 161Tb-labeled radioligands delivered on average ~ 38% higher absorbed doses in tissues as compared to their 177Lu-labeled counterparts. Conclusion: These results support the potential clinical translation of DOTAGA.Glu.(FAPI)2 and DO3A.Glu.(FAPI)2, as promising candidates for precise diagnosis and treatment of FAP-expressing malignancies.
      pubtype: Academic Journal
      doctype: Journal Article
      ougenre: Article
    language: English
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