On the automated radiosynthesis of pharmaceutical grade [Ga]Ga-Pentixafor, its pre-clinical evaluation, clinical application and radiation dosimetry aspects.

The current study outlines a consistent and reproducible protocol for the routine clinical dose preparation of [Ga]Ga-Pentixafor using the Eckert and Ziegler 'Modular-Lab Standard' non-cassette based automated module, that can be effectively used in the hospital radiopharmacy unit of a high volume nuclear medicine centre. The pre-clinical studies (including in-vitro cell line studies, in-vivo PET/CT imaging and pre-clinical dosimetry) were conducted to show the promising potential of the product for clinical use in targeting CXCR4 tumor overexpression. PET/CT image of SCID mouse bearing lymphoma xenograft tumor, at 2 h post-injection, clearly delineated the tumor. The pre-clinical dosimetry results show the suitability of the product for clinical use in patients. [Ga]Ga-Pentixafor when administered to patients with primary aldosteronism exhibited distinct uptake in the adrenal nodules. The clinical PET/CT scan of the patients demonstrated the potential use of CXCR4 targeted imaging as a promising surgical decision-making tool for patients with primary aldosteronism.