Optimization of the Use of the DOTATATE Kit Manufactured by the Thailand Institute of Nuclear Technology Using a SiO2-based 68Ge/68Ga Generator

Phattarayut Jaiuea; Somlak Kongmuang; Kanyapat Lumyong; Thanete Doungta; Shuichi Shiratori

doi:10.33192/smj.v76i11.270157

Authors

Phattarayut Jaiuea Department of Radiology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand
Somlak Kongmuang Department of Industrial Pharmacy, Faculty of Pharmacy, Silpakorn University, Thailand
Kanyapat Lumyong Thailand Institute of Nuclear Technology, Bangkok, Thailand
Thanete Doungta Thailand Institute of Nuclear Technology, Bangkok, Thailand
Shuichi Shiratori Department of Radiology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand

DOI:

https://doi.org/10.33192/smj.v76i11.270157

Keywords:

68Ga-DOTATATE, TINT kit, Neuroendocrine tumor, Ga-68 elution, Radiochemical purity

Abstract

Objective: The presence of somatostatin receptors on neuroendocrine tumours enables 68Ga-DOTATATE to precisely detect lesion localization and staging. Thailand Institute of Nuclear Technology (TINT) recently developed a DOTATATE kit for labelling with Ga-68, which is compatible with a TiO2-based 68Ge/68Ga generator eluted with 0.1 M HCl, but presents a discrepancy with other types of 68Ge/68Ga generators. This research aimed to optimize a radiolabelling method using TINT’s kit with a SiO2-based 68Ge/68Ga generator eluting Ga-68 in 0.05 M HCl. Additionally, a quality control protocol was developed to ensure the formulation’s efficacy and reliability in compliance with the 10th edition of the European Pharmacopoeia.

Material and Methods: The SiO2-based 68Ge/68Ga generator was eluted with 2–4 ml of 0.05 M HCl, added into a lyophilized kit, heated in a dried-block heater at 100 ºC for 15 min, cooled down at room temperature, and finally purified using Sep-Pak C18 cartridge. The radiochemical purity was determined by radio thin-layer chromatography and the radioactivity was measured by a gamma well counter. Reproducibility and stability tests were conducted three times.

Results: Employing 4 ml of eluted material, comprising the second and fifth millilitres of 68GaCl3, provided a radiochemical purity (RCP) exceeding 95% after purification. Also, 68Ga-DOTATATE remained stable in refrigerator for at least 4 half-lives.

Conclusion: TINT’s DOTATATE kit can be successfully labelled with a SiO2-based 68Ge/68Ga generator, providing 68Ga-DOTATATE with an RCP > 95% for at least 4 half-lives when stored in refrigerator after production. This radiolabelling procedure is suitable for routine clinical application.

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