A comparison of routine [ 68 Ga]Ga-PSMA-11 preparation using Locametz and Illuccix kits.

Autor: Wang IE; Department of Medicinal Chemistry, College of Pharmacy, University of Michigan, Ann Arbor, MI, 48109, USA., Morrissette LJ; Department of Radiology, University of Michigan, 2276 Medical Science 1, 1301 Catherine St., Ann Arbor, MI, 48109-5610, USA., Wong KK; Department of Radiology, University of Michigan, 2276 Medical Science 1, 1301 Catherine St., Ann Arbor, MI, 48109-5610, USA., Brooks AF; Department of Radiology, University of Michigan, 2276 Medical Science 1, 1301 Catherine St., Ann Arbor, MI, 48109-5610, USA., Dakanali M; Department of Radiology, University of Michigan, 2276 Medical Science 1, 1301 Catherine St., Ann Arbor, MI, 48109-5610, USA., Scott PJH; Department of Medicinal Chemistry, College of Pharmacy, University of Michigan, Ann Arbor, MI, 48109, USA. pjhscott@umich.edu.; Department of Radiology, University of Michigan, 2276 Medical Science 1, 1301 Catherine St., Ann Arbor, MI, 48109-5610, USA. pjhscott@umich.edu.; Department of Pharmacology, University of Michigan, Ann Arbor, MI, 48109, USA. pjhscott@umich.edu.
Jazyk: angličtina
Zdroj: EJNMMI radiopharmacy and chemistry [EJNMMI Radiopharm Chem] 2024 Dec 18; Vol. 9 (1), pp. 87. Date of Electronic Publication: 2024 Dec 18.
DOI: 10.1186/s41181-024-00317-4
Abstrakt: Background: Approval of Locametz and Illuccix kits for the manufacture of [ 68 Ga]Ga-PSMA-11 (gallium Ga68 gozetotide), a PET imaging agent for prostate cancer, as well as the corresponding therapeutic ([ 177 Lu]Lu-PSMA-617 Pluvicto), has led to a rapid increase in demand for [ 68 Ga]Ga-PSMA-11 PET imaging. Radiopharmaceutical manufacturers, using 68 Ge/ 68 Ga generators, may decide to adopt Locametz and/or Illuccix kits, which requires a comparison to select the most suitable kit for day-to-day use. The objective of this article is to compare both kits and provide guidance for selecting one for routine use, as well as evaluate labeling consistency of both kits during routine production. Additionally, we report our experience during 1.5 years of daily [ 68 Ga]Ga-PSMA-11 production at our facility using both kits.
Results: Locametz (n = 181) and Illuccix (n = 256) kits were prepared using non-silicone coated and silicone-coated needles with 68 Ga activities ranging from 0.53 to 3.16 GBq, with a failure rate of 1 in 128 runs for both kits. With Locametz, a 3.7 GBq generator and 10-min incubation at room temperature gave doses that passed quality control (QC) testing. Use of non-silicone coated needles in the process led to solution discoloration, and QC failure. Additionally, lack of vial inversion led to inconsistent labeling, which improved with subsequent vial agitation. For Illuccix, addition of the acetate buffer to the precursor vial prior to adding the [ 68 Ga]GaCl 3 simplifies the workflow. The maximum tolerated activity was 1.85 GBq. Lack of vial inversion led to failures, which were rectified by agitating the vial to properly incorporate the acetate solution with the generator eluate.
Conclusions: Both kits benefited from using a syringe pump to elute the 68 Ge/ 68 Ga generator, vial agitation, and longer length/smaller bore silicone coated needles. Both kits have similar workflows, comparable QC outcomes, and result in equivalent clinical images. Thus, the decision between kits will ultimately be determined by production preferences. Since radiopharmacies have an established "kit-based" workflow, Locametz kits with higher allowed activities and longer shelf-life may offer benefits. Conversely, more traditional PET manufacturing facilities might benefit from using Illuccix kits due to compatibility with cyclotron-produced [ 68 Ga]GaCl 3 allowing for kit batching. Ultimately, the commercial availability of 2 approved kits for production of [ 68 Ga]Ga-PSMA-11 PET has facilitated ready access to this important new imaging agent.
Competing Interests: Declarations. Ethics approval and consent to participate: Not applicable as this article does not contain any original research studies with human or animal subjects performed by any of the authors. Consent for publication: Not applicable as this article does not contain any original research studies with human or animal subjects performed by any of the authors. Availability of data and materials: Provided in the Supplementary Information is a list of Formulation, components of the Locametz and Illuccix kits (Table S1), as well as a list of disposable and non-disposable items used in both the production of Locametz (Table S2) and Illuccix (Table S3). Additionally, required materials for quality control is also provided (Table S4). Provided in an Excel sheet (Appendix A) is the raw data for all 437 PSMA-11 production batches reported and analyzed in this article. The preparer’s names have been replaced with generic names (Person A, Person B, etc.) in the Excel sheet, but reflect the actual radiochemists’s role for each batch. Conflict of Interests: IEW, LJM, KKW, AFB and MD disclose no competing interests. PJHS holds equity in Novartis and Telix Pharmaceuticals. Given his role as Associate Editor, Peter J. H. Scott had no involvement in the peer-review of this article and has no access to information regarding its peer-review.
(© 2024. The Author(s).)
Databáze: MEDLINE
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