Preparation of 177Lu-PSMA-617 in Hospital Radiopharmacy: Convenient Formulation of a Clinical Dose Using a Single-Vial Freeze-Dried PSMA-617 Kit Developed In-House

Objective. In the recent time, endoradionuclide therapy for metastatic castration-resistant prostate carcinoma employing 177Lu-PSMA-617 has yielded encouraging results and several clinical trials with the agent are currently ongoing. Routine preparation of 177Lu-PSMA-617 patient doses can be made si...

Descripción completa

Guardado en:
Detalles Bibliográficos
Autores principales: Mohini Guleria, Jeyachitra Amirdhanayagam, Haladhar D. Sarma, Ramya Priya Rallapeta, V. S. Krishnamohan, Ajit Nimmagadda, Parthasarathy Ravi, Sailaja Patri, Tekchand Kalawat, Tapas Das
Formato: article
Lenguaje:EN
Publicado: Hindawi Limited 2021
Materias:
R
Acceso en línea:https://doaj.org/article/51bd0afc08974ec99e5dcbba92b83e22
Etiquetas: Agregar Etiqueta
Sin Etiquetas, Sea el primero en etiquetar este registro!
id oai:doaj.org-article:51bd0afc08974ec99e5dcbba92b83e22
record_format dspace
spelling oai:doaj.org-article:51bd0afc08974ec99e5dcbba92b83e222021-11-29T00:55:57ZPreparation of 177Lu-PSMA-617 in Hospital Radiopharmacy: Convenient Formulation of a Clinical Dose Using a Single-Vial Freeze-Dried PSMA-617 Kit Developed In-House2314-614110.1155/2021/1555712https://doaj.org/article/51bd0afc08974ec99e5dcbba92b83e222021-01-01T00:00:00Zhttp://dx.doi.org/10.1155/2021/1555712https://doaj.org/toc/2314-6141Objective. In the recent time, endoradionuclide therapy for metastatic castration-resistant prostate carcinoma employing 177Lu-PSMA-617 has yielded encouraging results and several clinical trials with the agent are currently ongoing. Routine preparation of 177Lu-PSMA-617 patient doses can be made simpler and convenient, if the ingredients essential for radiolabeling are made available in a ready-to-use lyophilized form. Methods. PSMA-617 freeze-dried kit was formulated and used for the preparation of 177Lu-PSMA-617 clinical dose with high radiochemical purity using low/medium specific activity 177Lu. Detailed radiochemical studies were performed to determine the maximum activity and volume of 177LuCl3, which can be added in the kit for the formulation of 177Lu-PSMA-617. Studies were also performed to determine the shelf life of the kit to ensure its long-term usage. Studies were performed in buffer as well as human serum medium to determine the stability of the 177Lu-PSMA-617 complex after storing in respective media up to 7 days postpreparation. About ten patient doses of 177Lu-PSMA-617 were administered, and posttherapy scans were acquired. Results. The formulated freeze-dried kit of PSMA-617 could be radiolabeled with an average percentage radiochemical purity>98.53±0.38. The freeze-dried kit was found suitable for tolerating up to 0.5 mL of 177LuCl3 (in 0.01 N HCl) and specific activity of 555 MBq/μg (15 mCi/μg) for the preparation of the patient dose of 177Lu-PSMA-617. The 177Lu-PSMA-617 complex prepared using the freeze-dried kit of PSMA-617 was observed to maintain % radiochemical purity (RCP) of 96.74±0.87 and 94.81±2.66, respectively, even after storing up to 7 days in buffer and human serum, respectively. 177Lu-PSMA-617 prepared using the in-house formulated freeze-dried kit of PSMA-617 exhibited accumulation in metastatic lesions picked up in a pretherapy PET scan. Reduction in number as well as size of lesions was observed in posttherapy scans acquired after two months of administering the first therapeutic dose of 177Lu-PSMA-617. Conclusions. The freeze-dried kit of PSMA-617 could be used for the preparation of 177Lu-PSMA-617 with high radiochemical purity (>98%) in a reproducible manner. 177Lu-PSMA-617 prepared using the developed kit was successfully evaluated in patients suffering from metastatic prostate cancer.Mohini GuleriaJeyachitra AmirdhanayagamHaladhar D. SarmaRamya Priya RallapetaV. S. KrishnamohanAjit NimmagaddaParthasarathy RaviSailaja PatriTekchand KalawatTapas DasHindawi LimitedarticleMedicineRENBioMed Research International, Vol 2021 (2021)
institution DOAJ
collection DOAJ
language EN
topic Medicine
R
spellingShingle Medicine
R
Mohini Guleria
Jeyachitra Amirdhanayagam
Haladhar D. Sarma
Ramya Priya Rallapeta
V. S. Krishnamohan
Ajit Nimmagadda
Parthasarathy Ravi
Sailaja Patri
Tekchand Kalawat
Tapas Das
Preparation of 177Lu-PSMA-617 in Hospital Radiopharmacy: Convenient Formulation of a Clinical Dose Using a Single-Vial Freeze-Dried PSMA-617 Kit Developed In-House
description Objective. In the recent time, endoradionuclide therapy for metastatic castration-resistant prostate carcinoma employing 177Lu-PSMA-617 has yielded encouraging results and several clinical trials with the agent are currently ongoing. Routine preparation of 177Lu-PSMA-617 patient doses can be made simpler and convenient, if the ingredients essential for radiolabeling are made available in a ready-to-use lyophilized form. Methods. PSMA-617 freeze-dried kit was formulated and used for the preparation of 177Lu-PSMA-617 clinical dose with high radiochemical purity using low/medium specific activity 177Lu. Detailed radiochemical studies were performed to determine the maximum activity and volume of 177LuCl3, which can be added in the kit for the formulation of 177Lu-PSMA-617. Studies were also performed to determine the shelf life of the kit to ensure its long-term usage. Studies were performed in buffer as well as human serum medium to determine the stability of the 177Lu-PSMA-617 complex after storing in respective media up to 7 days postpreparation. About ten patient doses of 177Lu-PSMA-617 were administered, and posttherapy scans were acquired. Results. The formulated freeze-dried kit of PSMA-617 could be radiolabeled with an average percentage radiochemical purity>98.53±0.38. The freeze-dried kit was found suitable for tolerating up to 0.5 mL of 177LuCl3 (in 0.01 N HCl) and specific activity of 555 MBq/μg (15 mCi/μg) for the preparation of the patient dose of 177Lu-PSMA-617. The 177Lu-PSMA-617 complex prepared using the freeze-dried kit of PSMA-617 was observed to maintain % radiochemical purity (RCP) of 96.74±0.87 and 94.81±2.66, respectively, even after storing up to 7 days in buffer and human serum, respectively. 177Lu-PSMA-617 prepared using the in-house formulated freeze-dried kit of PSMA-617 exhibited accumulation in metastatic lesions picked up in a pretherapy PET scan. Reduction in number as well as size of lesions was observed in posttherapy scans acquired after two months of administering the first therapeutic dose of 177Lu-PSMA-617. Conclusions. The freeze-dried kit of PSMA-617 could be used for the preparation of 177Lu-PSMA-617 with high radiochemical purity (>98%) in a reproducible manner. 177Lu-PSMA-617 prepared using the developed kit was successfully evaluated in patients suffering from metastatic prostate cancer.
format article
author Mohini Guleria
Jeyachitra Amirdhanayagam
Haladhar D. Sarma
Ramya Priya Rallapeta
V. S. Krishnamohan
Ajit Nimmagadda
Parthasarathy Ravi
Sailaja Patri
Tekchand Kalawat
Tapas Das
author_facet Mohini Guleria
Jeyachitra Amirdhanayagam
Haladhar D. Sarma
Ramya Priya Rallapeta
V. S. Krishnamohan
Ajit Nimmagadda
Parthasarathy Ravi
Sailaja Patri
Tekchand Kalawat
Tapas Das
author_sort Mohini Guleria
title Preparation of 177Lu-PSMA-617 in Hospital Radiopharmacy: Convenient Formulation of a Clinical Dose Using a Single-Vial Freeze-Dried PSMA-617 Kit Developed In-House
title_short Preparation of 177Lu-PSMA-617 in Hospital Radiopharmacy: Convenient Formulation of a Clinical Dose Using a Single-Vial Freeze-Dried PSMA-617 Kit Developed In-House
title_full Preparation of 177Lu-PSMA-617 in Hospital Radiopharmacy: Convenient Formulation of a Clinical Dose Using a Single-Vial Freeze-Dried PSMA-617 Kit Developed In-House
title_fullStr Preparation of 177Lu-PSMA-617 in Hospital Radiopharmacy: Convenient Formulation of a Clinical Dose Using a Single-Vial Freeze-Dried PSMA-617 Kit Developed In-House
title_full_unstemmed Preparation of 177Lu-PSMA-617 in Hospital Radiopharmacy: Convenient Formulation of a Clinical Dose Using a Single-Vial Freeze-Dried PSMA-617 Kit Developed In-House
title_sort preparation of 177lu-psma-617 in hospital radiopharmacy: convenient formulation of a clinical dose using a single-vial freeze-dried psma-617 kit developed in-house
publisher Hindawi Limited
publishDate 2021
url https://doaj.org/article/51bd0afc08974ec99e5dcbba92b83e22
work_keys_str_mv AT mohiniguleria preparationof177lupsma617inhospitalradiopharmacyconvenientformulationofaclinicaldoseusingasinglevialfreezedriedpsma617kitdevelopedinhouse
AT jeyachitraamirdhanayagam preparationof177lupsma617inhospitalradiopharmacyconvenientformulationofaclinicaldoseusingasinglevialfreezedriedpsma617kitdevelopedinhouse
AT haladhardsarma preparationof177lupsma617inhospitalradiopharmacyconvenientformulationofaclinicaldoseusingasinglevialfreezedriedpsma617kitdevelopedinhouse
AT ramyapriyarallapeta preparationof177lupsma617inhospitalradiopharmacyconvenientformulationofaclinicaldoseusingasinglevialfreezedriedpsma617kitdevelopedinhouse
AT vskrishnamohan preparationof177lupsma617inhospitalradiopharmacyconvenientformulationofaclinicaldoseusingasinglevialfreezedriedpsma617kitdevelopedinhouse
AT ajitnimmagadda preparationof177lupsma617inhospitalradiopharmacyconvenientformulationofaclinicaldoseusingasinglevialfreezedriedpsma617kitdevelopedinhouse
AT parthasarathyravi preparationof177lupsma617inhospitalradiopharmacyconvenientformulationofaclinicaldoseusingasinglevialfreezedriedpsma617kitdevelopedinhouse
AT sailajapatri preparationof177lupsma617inhospitalradiopharmacyconvenientformulationofaclinicaldoseusingasinglevialfreezedriedpsma617kitdevelopedinhouse
AT tekchandkalawat preparationof177lupsma617inhospitalradiopharmacyconvenientformulationofaclinicaldoseusingasinglevialfreezedriedpsma617kitdevelopedinhouse
AT tapasdas preparationof177lupsma617inhospitalradiopharmacyconvenientformulationofaclinicaldoseusingasinglevialfreezedriedpsma617kitdevelopedinhouse
_version_ 1718407706191069184