Development of a single vial kit solution for radiolabeling of 68Ga-DKFZ-PSMA-11 and its performance in prostate cancer patients

Show simple item record Ebenhan, Thomas Vorster, Mariza Marjanovic-Painter, Biljana Wagener, Judith Suthiram, J. Modiselle, Moshe Mokaleng, Botshelo B. Zeevaart, Jan Rijn Sathekge, Mike Machaba 2016-03-03T06:09:47Z 2016-03-03T06:09:47Z 2015-08-14
dc.description.abstract Prostate-specific membrane antigen (PSMA), a type II glycoprotein, is highly expressed in almost all prostate cancers. By playing such a universal role in the disease, PSMA provides a target for diagnostic imaging of prostate cancer using positron emission tomography/computed tomography (PET/CT). The PSMA-targeting ligand Glu-NH-CONH- Lys-(Ahx)-HBED-CC (DKFZ-PSMA-11) has superior imaging properties and allows for highly-specific complexation of the generator-based radioisotope Gallium-68 (68Ga). However, only module-based radiolabeling procedures are currently available. This study intended to develop a single vial kit solution to radiolabel buffered DKFZ-PSMA-11 with 68Ga. A 68Ge/68Ga-generator was utilized to yield 68GaCl3 and major aspects of the kit development were assessed, such as radiolabeling performance, quality assurance, and stability. The final product was injected into patients with prostate cancer for PET/CT imaging and the kit performance was evaluated on the basis of the expected biodistribution, lesion detection, and dose optimization. Kits containing 5 nmol DKFZ-PSMA-11 showed rapid, quantitative 68Ga-complexation and all quality measurements met the release criteria for human application. The increased precursor content did not compromise the ability of 68Ga-DKFZ-PSMA-11 PET/CT to detect primary prostate cancer and its advanced lymphaticand metastatic lesions. The 68Ga-DKFZ-PSMA-11 kit is a robust, ready-to-use diagnostic agent in prostate cancer with high diagnostic performance. en_ZA
dc.description.librarian am2015 en_ZA
dc.description.sponsorship The Department of Science and Technology, The South African Nuclear Energy Corporation and the Nuclear Technologies in Medicine and the Biosciences Initiative. en_ZA
dc.description.uri en_ZA
dc.identifier.citation Ebenhan, T, Vorster, M, Marjanovic-Painter, B, Wagener, J, Suthiram, J, Modiselle, M, Mokaleng, B, Zeevaart, JR & Sathekge, M 2015, 'Development of a single vial kit Solution for radiolabeling of 68Ga-DKFZ-PSMA-11 and its performance in prostate cancer patients', Molecules, vol. 20, pp. 14860-14878. en_ZA
dc.identifier.issn 1420-3049
dc.identifier.other 10.3390/molecules200814860
dc.language.iso en en_ZA
dc.publisher MDPI Publishing en_ZA
dc.rights © 2015 by the authors; licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution license. en_ZA
dc.subject Prostate cancer en_ZA
dc.subject 68Ga-HBED-CC-(Ahx)Lys-NH-CO-NH-Glu en_ZA
dc.subject 68Ga-DKFZ-PSMA-11 en_ZA
dc.subject 68Ga-PSMAHBED en_ZA
dc.subject Prostate-specific membrane antigen (PSMA) en_ZA
dc.subject Positron emission tomography/computed tomography (PET/CT) en_ZA
dc.title Development of a single vial kit solution for radiolabeling of 68Ga-DKFZ-PSMA-11 and its performance in prostate cancer patients en_ZA
dc.type Article en_ZA

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