Drishty Satpati1, Ajit Shinto2, K K Kamaleshwaran2, Surekha Sane3, Sharmila Banerjee4. 1. Radiopharmaceuticals Chemistry Section, Radiochemistry & Isotope Group, Bhabha Atomic Research Centre, Mumbai, India. drishtys77@gmail.com. 2. Nuclear Medicine Department, Kovai Medical Center and Hospital, Coimbatore, India. 3. Radiopharmaceuticals Chemistry Section, Radiochemistry & Isotope Group, Bhabha Atomic Research Centre, Mumbai, India. 4. Radiopharmaceuticals Chemistry Section, Radiochemistry & Isotope Group, Bhabha Atomic Research Centre, Mumbai, India. sharmila@barc.gov.in.
Abstract
PURPOSE: [(68)Ga]DKFZ-PSMA-11 has proved to be an important diagnostic radiotracer for targeting prostate-specific membrane antigen (PSMA) overexpression in both recurrent prostate cancer (PC) and relevant metastatic sites. However, the widespread, routine clinical use of such a potential radiopharmaceutical demands availability of a ready-to-use kit formulation to enable convenient radiopharmaceutical preparation. Herein, we report the development of a freeze-dried kit vial for the formulation of [(68)Ga]DKFZ-PSMA-11 and its clinical use in patients using a "shake-bake-inject" methodology. PROCEDURES: The freeze-dried kit vial was developed after optimization of ligand content (PSMA-11) and pH conditions. The kit was formulated using (68)Ga from two different commercially available generators. Positron emission tomography/X-ray computed tomography (PET/CT) images of PC patients were obtained using the kit-formulated radiotracer. RESULTS: [(68)Ga]DKFZ-PSMA-11 was prepared in >98 % radiochemical yield and purity using the freeze-dried kit vials. Kits were optimized for the preparation of four patient doses. The clinical utility was evaluated in patients with histologically confirmed prostate cancer, and the images were of good quality as well as conforming to tumor marker and clinical expectations. CONCLUSION: The development of a simple and ready-to-use freeze-dried DKFZ-PSMA-11 kit for the preparation of Ga-68-based radiotracers constitutes a major step towards the expedition of the widespread and economical screening of PC patients.
PURPOSE: [(68)Ga]DKFZ-PSMA-11 has proved to be an important diagnostic radiotracer for targeting prostate-specific membrane antigen (PSMA) overexpression in both recurrent prostate cancer (PC) and relevant metastatic sites. However, the widespread, routine clinical use of such a potential radiopharmaceutical demands availability of a ready-to-use kit formulation to enable convenient radiopharmaceutical preparation. Herein, we report the development of a freeze-dried kit vial for the formulation of [(68)Ga]DKFZ-PSMA-11 and its clinical use in patients using a "shake-bake-inject" methodology. PROCEDURES: The freeze-dried kit vial was developed after optimization of ligand content (PSMA-11) and pH conditions. The kit was formulated using (68)Ga from two different commercially available generators. Positron emission tomography/X-ray computed tomography (PET/CT) images of PC patients were obtained using the kit-formulated radiotracer. RESULTS: [(68)Ga]DKFZ-PSMA-11 was prepared in >98 % radiochemical yield and purity using the freeze-dried kit vials. Kits were optimized for the preparation of four patient doses. The clinical utility was evaluated in patients with histologically confirmed prostate cancer, and the images were of good quality as well as conforming to tumor marker and clinical expectations. CONCLUSION: The development of a simple and ready-to-use freeze-dried DKFZ-PSMA-11 kit for the preparation of Ga-68-based radiotracers constitutes a major step towards the expedition of the widespread and economical screening of PC patients.
Authors: Shankar Vallabhajosula; Anastasia Nikolopoulou; John W Babich; Joseph R Osborne; Scott T Tagawa; Irina Lipai; Lilja Solnes; Kevin P Maresca; Thomas Armor; John L Joyal; Robert Crummet; James B Stubbs; Stanley J Goldsmith Journal: J Nucl Med Date: 2014-10-23 Impact factor: 10.057
Authors: Zsolt Szabo; Esther Mena; Steven P Rowe; Donika Plyku; Rosa Nidal; Mario A Eisenberger; Emmanuel S Antonarakis; Hong Fan; Robert F Dannals; Ying Chen; Ronnie C Mease; Melin Vranesic; Akrita Bhatnagar; George Sgouros; Steve Y Cho; Martin G Pomper Journal: Mol Imaging Biol Date: 2015-08 Impact factor: 3.488
Authors: A Afshar-Oromieh; A Malcher; M Eder; M Eisenhut; H G Linhart; B A Hadaschik; T Holland-Letz; F L Giesel; C Kratochwil; S Haufe; U Haberkorn; C M Zechmann Journal: Eur J Nucl Med Mol Imaging Date: 2012-11-24 Impact factor: 9.236
Authors: Giuseppe Floresta; Siham Memdouh; Truc Pham; Michelle T Ma; Philip J Blower; Robert C Hider; Vincenzo Abbate; Agostino Cilibrizzi Journal: Dalton Trans Date: 2022-08-30 Impact factor: 4.569
Authors: Marcin Czarniecki; Esther Mena; Liza Lindenberg; Marek Cacko; Stephanie Harmon; Jan Philipp Radtke; Frederick Giesel; Baris Turkbey; Peter L Choyke Journal: Transl Androl Urol Date: 2018-10