Bibliographic Details
| Title: |
Production and Quality Control of [177Lu]Lu-PSMA-I&T: Development of an Investigational Medicinal Product Dossier for Clinical Trials |
| Authors: |
Valentina Di Iorio, Stefano Boschi, Cristina Cuni, Manuela Monti, Stefano Severi, Giovanni Paganelli, Carla Masini |
| Source: |
Molecules, Vol 27, Iss 13, p 4143 (2022) |
| Publisher Information: |
MDPI AG, 2022. |
| Publication Year: |
2022 |
| Collection: |
LCC:Organic chemistry |
| Subject Terms: |
prostate cancer, [177Lu]Lu-PSMA-I&T, IMPD, quality assurance, Organic chemistry, QD241-441 |
| More Details: |
Since prostate cancer is the most commonly diagnosed malignancy in men, the theranostic approach has become very attractive since the discovery of urea-based PSMA inhibitors. Different molecules have been synthesized starting from the Glu-urea-Lys scaffold as the pharmacophore and then optimizing the linker and the chelate to improve functional characteristics. This article aimed to highlight the quality aspects, which could have an impact on clinical practice, describing the development of an Investigational Medicinal Product Dossier (IMPD) for clinical trials with [177Lu]Lu-PSMA-I&T in prostate cancer and other solid tumors expressing PSMA. The results highlighted some important quality issues of the final preparation: radiolabeling of PSMA-I&T with lutetium-177 needs a considerably longer time compared with the radiolabeling of the well-known [177Lu]Lu-PSMA-617. When the final product was formulated in saline, the stability of [177Lu]Lu-PSMA-I&T was reduced by radiolysis, showing a decrease in radiochemical purity ( |
| Document Type: |
article |
| File Description: |
electronic resource |
| Language: |
English |
| ISSN: |
1420-3049 |
| Relation: |
https://www.mdpi.com/1420-3049/27/13/4143; https://doaj.org/toc/1420-3049 |
| DOI: |
10.3390/molecules27134143 |
| Access URL: |
https://doaj.org/article/41d2c56db6e343718dcde794f2a09f7d |
| Accession Number: |
edsdoj.41d2c56db6e343718dcde794f2a09f7d |
| Database: |
Directory of Open Access Journals |
