Haim Golan1,2, Moad Esa3, Keren Moshkoviz3, Asher Feldhaim4, Baruch Hoch4, Eli Shalom4. 1. Theranostics and Molecular Imaging, Isotopia Molecular Imaging LTD. 2. Quality Assurance Department, Isotopia Molecular Imaging LTD. 3. Radiopharmacy Department, Isotopia Molecular Imaging LTD. 4. Research and Development Department, Isotopia Molecular Imaging LTD, 39 Alexander Yanay St., Petach Tikva, Israel.
Abstract
INTRODUCTION: The authors describe the newly proposed synthesis technique for the gallium-68 (Ga-68)-labeled tracer ([Ga]Ga-PSMA-HBED-CC) for imaging expression of the prostate-specific membrane antigen (PSMA). An effort was applied to design the lyophilized cold kit (isoPROtrace-11) as a time-saving technique resulting in increased radiochemical yields. PROCEDURES: The initial material for labeling was obtained from a Ge/Ga-generator. For labeling with the lyophilized cold kit isoPROtrace-11, 2.5 ml 0.1 M HCl of the middle Ga-68 elution fraction were added to the kit, shook for dissolving the vial's contents and kept for 5 minutes at room temperature. A systematic comparison was carried out between results obtained with the cold kit technique and with previously used Modular-Lab module concerning the radiochemical yield, purity, and the time of producing. RESULTS: Automated module-involved synthesis of [Ga]Ga-PSMA-HBED- CC resulted in a radiochemical yield of 84.2 ± 6.3% and purity of >95% after 25 minutes. The room temperature cold kit gave a radiochemical yield of >98% and purity of >95% after 5 minutes. CONCLUSION: Using the kit method reduced the labeling time. The cold kit method increased production efficiency because less of the eluted Ga-68 was wasted.
INTRODUCTION: The authors describe the newly proposed synthesis technique for the gallium-68 (Ga-68)-labeled tracer ([Ga]Ga-PSMA-HBED-CC) for imaging expression of the prostate-specific membrane antigen (PSMA). An effort was applied to design the lyophilized cold kit (isoPROtrace-11) as a time-saving technique resulting in increased radiochemical yields. PROCEDURES: The initial material for labeling was obtained from a Ge/Ga-generator. For labeling with the lyophilized cold kit isoPROtrace-11, 2.5 ml 0.1 M HCl of the middle Ga-68 elution fraction were added to the kit, shook for dissolving the vial's contents and kept for 5 minutes at room temperature. A systematic comparison was carried out between results obtained with the cold kit technique and with previously used Modular-Lab module concerning the radiochemical yield, purity, and the time of producing. RESULTS: Automated module-involved synthesis of [Ga]Ga-PSMA-HBED- CC resulted in a radiochemical yield of 84.2 ± 6.3% and purity of >95% after 25 minutes. The room temperature cold kit gave a radiochemical yield of >98% and purity of >95% after 5 minutes. CONCLUSION: Using the kit method reduced the labeling time. The cold kit method increased production efficiency because less of the eluted Ga-68 was wasted.
Authors: Gary L Griffiths; Crystal Vasquez; Freddy Escorcia; Jeff Clanton; Liza Lindenberg; Esther Mena; Peter L Choyke Journal: Adv Drug Deliv Rev Date: 2021-12-20 Impact factor: 15.470