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Pharmaceuticals
Volume 17
Issue 9
10.3390/ph17091141
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This is an early access version, the complete PDF, HTML, and XML versions will be available soon.
Article

[68Ga]Ga-FAP-2286—Synthesis, Quality Control and Comparison with [18F]FDG PET/CT in a Patient with Suspected Cholangiocellular Carcinoma

by
Anton Amadeus Hörmann
*,†,
Gregor Schweighofer-Zwink
†,
Gundula Rendl
,
Kristina Türk
,
Samuel Nadeje
,
Kristina Haas
,
Theresa Jung
,
Ursula Huber-Schönauer
,
Lukas Hehenwarter
,
Mohsen Beheshti
and
Christian Pirich
Department of Nuclear Medicine and Endocrinology, University Hospital Salzburg, Paracelsus Medical University, 5020 Salzburg, Austria
*
Author to whom correspondence should be addressed.
†
These authors contributed equally to this work.
Pharmaceuticals 2024, 17(9), 1141; https://doi.org/10.3390/ph17091141
Submission received: 30 July 2024 / Revised: 18 August 2024 / Accepted: 28 August 2024 / Published: 29 August 2024
(This article belongs to the Special Issue Past, Present and Future Radiotracer Techniques: Radiopharmaceuticals in Cancer Theranostics)
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Abstract

[68Ga]Ga-FAP-2286 is a new peptide-based radiopharmaceutical for positron-emission tomography (PET) that targets fibroblast activation protein (FAP). This article describes in detail the automated synthesis of [68Ga]Ga-FAP-2286 using a commercially available synthesis tool that includes quality control for routine clinical applications. The synthesis was performed using a Scintomics GRP-3V module and a GMP grade 68Ge/68Ga generator. A minor alteration for transferring the eluate to the module was established, eliminating the need for new method programming. Five batches of [68Ga]Ga-FAP-2286 were tested to validate the synthesis. A stability analysis was conducted up to 3 hours after production to determine the shelf-life of the finished product. The automated synthesis on the Scintomics GRP-3V synthesis module was found to be compliant with all quality control requirements. The shelf-life of the product was set to 2 h post-production based on the stability study. A patient suffering from cholangiocellular carcinoma that could not be clearly detected by conventional imaging, including a [18F]FDG-PET/CT, highlights the potential use of [68Ga]Ga-FAP-PET/CT.
Keywords: gallium-68; FAP; automated synthesis; PET/CT; FDG-negative cancer; imaging cholangiocellular carcinoma gallium-68; FAP; automated synthesis; PET/CT; FDG-negative cancer; imaging cholangiocellular carcinoma

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MDPI and ACS Style

Hörmann, A.A.; Schweighofer-Zwink, G.; Rendl, G.; Türk, K.; Nadeje, S.; Haas, K.; Jung, T.; Huber-Schönauer, U.; Hehenwarter, L.; Beheshti, M.; et al. [68Ga]Ga-FAP-2286—Synthesis, Quality Control and Comparison with [18F]FDG PET/CT in a Patient with Suspected Cholangiocellular Carcinoma. Pharmaceuticals 2024, 17, 1141. https://doi.org/10.3390/ph17091141

AMA Style

Hörmann AA, Schweighofer-Zwink G, Rendl G, Türk K, Nadeje S, Haas K, Jung T, Huber-Schönauer U, Hehenwarter L, Beheshti M, et al. [68Ga]Ga-FAP-2286—Synthesis, Quality Control and Comparison with [18F]FDG PET/CT in a Patient with Suspected Cholangiocellular Carcinoma. Pharmaceuticals. 2024; 17(9):1141. https://doi.org/10.3390/ph17091141

Chicago/Turabian Style

Hörmann, Anton Amadeus, Gregor Schweighofer-Zwink, Gundula Rendl, Kristina Türk, Samuel Nadeje, Kristina Haas, Theresa Jung, Ursula Huber-Schönauer, Lukas Hehenwarter, Mohsen Beheshti, and et al. 2024. "[68Ga]Ga-FAP-2286—Synthesis, Quality Control and Comparison with [18F]FDG PET/CT in a Patient with Suspected Cholangiocellular Carcinoma" Pharmaceuticals 17, no. 9: 1141. https://doi.org/10.3390/ph17091141

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