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CC BY 4.0 · World J Nucl Med
DOI: 10.1055/s-0045-1814733
Original Article

Scalable 68Ga Cold Kit Radiolabeling: High-Throughput Preparation of [68Ga]Ga-Edotreotide via Aliquoting and Dual Generator Strategy

Authors

  • Johanne Vanney

    1   Department of Nuclear Medicine, Institut Régional du Cancer de Montpellier (ICM), Univ. Montpellier, Montpellier, France

  • Jade Torchio

    1   Department of Nuclear Medicine, Institut Régional du Cancer de Montpellier (ICM), Univ. Montpellier, Montpellier, France

  • Stéphane C. Renaud

    1   Department of Nuclear Medicine, Institut Régional du Cancer de Montpellier (ICM), Univ. Montpellier, Montpellier, France

  • Marine M. Cadet

    1   Department of Nuclear Medicine, Institut Régional du Cancer de Montpellier (ICM), Univ. Montpellier, Montpellier, France

  • Léa Rubira

    1   Department of Nuclear Medicine, Institut Régional du Cancer de Montpellier (ICM), Univ. Montpellier, Montpellier, France

  • Cyril Fersing 

    1   Department of Nuclear Medicine, Institut Régional du Cancer de Montpellier (ICM), Univ. Montpellier, Montpellier, France
    2   IBMM, Univ Montpellier, CNRS, ENSCM, Montpellier, France
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Abstract

Objectives

The aim of the study was to develop and assess alternative radiolabeling strategies for SOMAKIT-TOC using gallium-68, with the aim of improving cost-efficiency by increasing the number of examinations per cold kit while maintaining radiochemical quality suitable for clinical use.

Materials and Methods

Four protocols were evaluated using triplicate test radiolabelings: (1) the reference method using a single generator and a full kit; (2) dual-generator elution into a full kit; (3) single-generator elution into two sequentially radiolabeled aliquots from one kit; and (4) dual-generator elution into two sequentially radiolabeled aliquots from one kit. Radiochemical purity (RCP) was assessed by radio-thin layer chromatography (rTLC) and radio-high performance liquid chromatography (rHPLC), and radiochemical stability was monitored over 4 hours. Additional quality controls parameters included pH, sterility, and peptide integrity in aliquot solution. Procedures 1 and 3 were further assessed in clinical routine.

Results

All protocols yielded radiopharmaceuticals with mean RCP values above 95% by rTLC. Procedure 2 significantly increased the final activity compared with Procedure 1. Procedure 3 enabled doubling the number of examinations per kit while maintaining RCP comparable to the reference method Procedure 4 showed greater variability. Radiolabeled products remained stable over 4 hours as assessed by rTLC, although rHPLC revealed a gradual decrease in purity. In clinical use, Procedure 3 allowed 94 preparations that met diagnostic needs, though 33% had RCP between 80 and 95%.

Conclusion

Aliquoting a single cold kit for dual radiolabeling using one generator is feasible and cost-effective, although it is associated with greater RCP variability. Dual-generator strategies yield higher activity but may further compromise RCP. Further optimization is required to improve robustness of off-label protocols while preserving the highest product quality.

Keywords

edotreotide - radiolabeling - gallium-68 - radiopharmaceuticals - PET imaging - neuroendocrine tumors

Data Availability Statement

Data are available upon reasonable request.


Authors' Contributions

C.F. and L.R. conceptualized the manuscript. C.F. wrote and prepared the original draft and worked on the methodology. J.V., L.R., J.T., M.M.C., C.F. investigated the content. L.R., J.V., and S.C.R. wrote, reviewed, and edited the content. J.V., L.R., J.T., M.M.C., and C.F. visualized the manuscript. C.F. supervised the content. All authors have read and agreed to the published version of the manuscript.


Supplementary Material



Publication History

Article published online:
05 January 2026

© 2026. The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution License, permitting unrestricted use, distribution, and reproduction so long as the original work is properly cited. (https://creativecommons.org/licenses/by/4.0/)

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