Optimization of the Use of the DOTATATE Kit Manufactured by the Thailand Institute of Nuclear Technology Using a SiO2-based 68Ge/68Ga Generator
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 68...
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Faculty of Medicine Siriraj Hospital
2024-11-01
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| Series: | Siriraj Medical Journal |
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| Online Access: | https://he02.tci-thaijo.org/index.php/sirirajmedj/article/view/270157 |
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| author | Phattarayut Jaiuea Somlak Kongmuang Kanyapat Lumyong Thanete Doungta Shuichi Shiratori |
| author_facet | Phattarayut Jaiuea Somlak Kongmuang Kanyapat Lumyong Thanete Doungta Shuichi Shiratori |
| author_sort | Phattarayut Jaiuea |
| collection | DOAJ |
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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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| format | Article |
| id | doaj-art-73656f1803924cd99214e1c2eb201d9c |
| institution | Kabale University |
| issn | 2228-8082 |
| language | English |
| publishDate | 2024-11-01 |
| publisher | Faculty of Medicine Siriraj Hospital |
| record_format | Article |
| series | Siriraj Medical Journal |
| spelling | doaj-art-73656f1803924cd99214e1c2eb201d9c2024-11-29T07:35:42ZengFaculty of Medicine Siriraj HospitalSiriraj Medical Journal2228-80822024-11-017611Optimization of the Use of the DOTATATE Kit Manufactured by the Thailand Institute of Nuclear Technology Using a SiO2-based 68Ge/68Ga GeneratorPhattarayut Jaiuea0Somlak Kongmuang1Kanyapat Lumyong2Thanete Doungta3Shuichi Shiratori4Department of Radiology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, ThailandDepartment of Industrial Pharmacy, Faculty of Pharmacy, Silpakorn University, ThailandThailand Institute of Nuclear Technology, Bangkok, ThailandThailand Institute of Nuclear Technology, Bangkok, ThailandDepartment of Radiology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand 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. https://he02.tci-thaijo.org/index.php/sirirajmedj/article/view/27015768Ga-DOTATATETINT kitNeuroendocrine tumorGa-68 elutionRadiochemical purity |
| spellingShingle | Phattarayut Jaiuea Somlak Kongmuang Kanyapat Lumyong Thanete Doungta Shuichi Shiratori Optimization of the Use of the DOTATATE Kit Manufactured by the Thailand Institute of Nuclear Technology Using a SiO2-based 68Ge/68Ga Generator Siriraj Medical Journal 68Ga-DOTATATE TINT kit Neuroendocrine tumor Ga-68 elution Radiochemical purity |
| title | Optimization of the Use of the DOTATATE Kit Manufactured by the Thailand Institute of Nuclear Technology Using a SiO2-based 68Ge/68Ga Generator |
| title_full | Optimization of the Use of the DOTATATE Kit Manufactured by the Thailand Institute of Nuclear Technology Using a SiO2-based 68Ge/68Ga Generator |
| title_fullStr | Optimization of the Use of the DOTATATE Kit Manufactured by the Thailand Institute of Nuclear Technology Using a SiO2-based 68Ge/68Ga Generator |
| title_full_unstemmed | Optimization of the Use of the DOTATATE Kit Manufactured by the Thailand Institute of Nuclear Technology Using a SiO2-based 68Ge/68Ga Generator |
| title_short | Optimization of the Use of the DOTATATE Kit Manufactured by the Thailand Institute of Nuclear Technology Using a SiO2-based 68Ge/68Ga Generator |
| title_sort | optimization of the use of the dotatate kit manufactured by the thailand institute of nuclear technology using a sio2 based 68ge 68ga generator |
| topic | 68Ga-DOTATATE TINT kit Neuroendocrine tumor Ga-68 elution Radiochemical purity |
| url | https://he02.tci-thaijo.org/index.php/sirirajmedj/article/view/270157 |
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