Automated production of [F-18]SiTATE on a Scintomics GRP (TM) platform for PET/CT imaging of neuroendocrine tumors

Lindner, Simon; Simmet, Marcel; Gildehaus, Franz Josef; Jurkschat, Klaus; Waengler, Carmen; Waengler, Björn; Bartenstein, Peter; Schirrmacher, Ralf und Ilhan, Harun (2020): Automated production of [F-18]SiTATE on a Scintomics GRP (TM) platform for PET/CT imaging of neuroendocrine tumors. In: Nuclear Medicine and Biology, Bd. 88-89: S. 86-95

Abstract

Introduction: a [F-18]SiTATE (formerly known as [F-18]SdAlin-TATE) was recently introduced as a highly promising imaging agent for the diagnosis of well-differentiated neuroendocrine tumors (NET) using positron emission tomography/computed tomography (PET/CT). A high tumor uptake and excellent image quality, the straightforward labeling approach, as well as the economic and logistic advantages of F-18-over Ga-68-labeled compounds predestinate [F-18]SiTATE to become a potential new clinical reference standard. A novel state-of-the-art methodology of automated radiopharmaceutical production is required to establish [F-18]SiTATE in clinical routine. This work illustrates the development of a novel synthesis procedure of [F-18]SiTATE on an automated synthesis unit (ASU) and the clinical applicability of the tracer in human NET imaging. Methods: A new synthesis protocol was generated for the production of [F-18]SiTATE on the Scintomics GRP (TM) platform for clinical NET imaging. The synthesis was carried out according to common Good Manufacturing Practice (GMP) guidelines including all quality control measurements. To confirm utility, clinical batches (n = 3) were produced and applied to six patients diagnosed with NET. Results: [F-18]SiTATE was obtained in 54 +/- 4% (n = 3) non-decay corrected radiochemical yield (RCY), with a radiochemical purity of 96.3 +/- 0.1% and a molar activity (A(m)) of 472 +/- 45 GBq/mu mol (n= 3). Quality control measurements always met the local release criteria. All specifications were taken or adapted from the Ph.Eur. regulations. PET/CT imaging with [F-18]SiTATE produced on the GRPTM module confirmed the expected high image quality. The in vivo distribution pattern and excellent tumor to non-tumor contrast observed, matched the quality of the manually prepared [F-18]SiTATE batches. Conclusions: The automated manufacture of [F-18]SiTATE was developed using the Scintomics GRP (TM) platform. The high quality of the radiotracer matched stringent quality control requirements adhering to common GMP guidelines, and its dinical applicability was confirmed by human PET/CT investigations. Advances in knowledge and implications for patient care: The automated process for the manufacture of [F-18]SiTATE described herein represents an important contribution to make [F-18]SiTATE routinely accessible for its use in clinical NET diagnosis.

• Dokumententyp: Zeitschriftenartikel
• Fakultät: Medizin
• Themengebiete: 600 Technik, Medizin, angewandte Wissenschaften > 610 Medizin und Gesundheit
• ISSN: 0969-8051
• Sprache: Englisch