Rizzello Marzia, Pacelli Anna, De Bari Maria Domenica, Cutrignelli Annalisa, Iacobazzi Rosa Maria, Lopalco Antonio, Denora Nunzio
BeForPharma S.r.l., Volga Street c/o Fiera del Levante Pad. 129, 70132 Bari, Italy.
Department of Pharmacy-Pharmaceutical Sciences, University of Bari Aldo Moro, 4, E. Orabona Street, 70125 Bari, Italy.
Pharmaceutics. 2025 Jun 20;17(7):802. doi: 10.3390/pharmaceutics17070802.
Gallium-68 (Ga) radiopharmaceuticals are increasingly used in nuclear medicine due to their rapid production capabilities and exceptional specificity in molecular imaging applications. Several of these tracers have demonstrated remarkable clinical efficacy across various oncological conditions, including prostate cancer, neuro-endocrine tumours, and cancers expressing fibroblast activation protein. Commercial kits allow the use of the standardised production protocol, but extemporaneous preparations are the economic and flexible alternatives, particularly within hospital-based radiopharmacy settings. However, such preparations need meticulous conformity to quality control measures and regulation to ensure safety and effectiveness. This review provides an analysis of current methodologies employed in Ga extemporaneous preparations and examines pertinent regulatory frameworks. Further clinical validation trials and technical advancement remain essential to facilitate the routine clinical practice's widespread usage and long-term feasibility of such preparations.
由于镓-68(Ga)放射性药物具有快速生产能力以及在分子成像应用中具有出色的特异性,因此在核医学中的应用越来越广泛。其中几种示踪剂已在包括前列腺癌、神经内分泌肿瘤以及表达成纤维细胞活化蛋白的癌症等各种肿瘤疾病中显示出显著的临床疗效。商业试剂盒允许使用标准化生产方案,但临时配制是经济且灵活的替代方案,特别是在医院放射性药房环境中。然而,此类配制需要严格符合质量控制措施和法规,以确保安全性和有效性。本综述分析了当前用于Ga临时配制的方法,并审视了相关的监管框架。进一步的临床验证试验和技术进步对于促进此类配制在常规临床实践中的广泛应用和长期可行性仍然至关重要。