Studies on batch formulation of a freeze dried kit for the preparation of 99mTc-HYNIC-TATE for imaging neuroendocrine tumors. (March 2019)

• Record Type: Journal Article
• Authors: Mukherjee, Archana; Korde, Aruna; Shinto, Ajit; Sarma, Haladhar Dev; Kamaleswaran, Koramadai; Dash, Ashutosh
• Is Part Of: Applied radiation and isotopes. Volume 145(2019:Mar.)
• Page Start: 180
• Page End: 186
• Publication Date: 2019-03
• Subjects: 99mTc-HYNIC-Octreotate (99mTc-HYNIC-TATE) -- Neuroendocrine tumors (NET) -- Somatostatin receptors -- Diagnostic imaging; Radiology -- Periodicals; Radiation -- Industrial applications -- Periodicals; Nuclear chemistry -- Periodicals; Internet resource; Periodical; 660.298
• DOI: 10.1016/j.apradiso.2018.12.027
• Languages: English
• ISSNs: 0969-8043

Abstract

Abstract: Aim: To formulate freeze dried cold kits for preparation of 99m Tc-HYNIC-TATE suitable for use at hospital radiopharmacy and establish clinical utility of 99m Tc-HYNIC-TATE prepared using kits for detection of neuroendocrine tumors (NETs). Methods: Standardization of reagent concentrations for formulation of freeze dried kits of HYNIC-TATE was carried out. Consistency in formulation was tested by six batch preparation. Quality control tests were carried out to establish compliance of specifications of purity and safety criteria for both kits and 99m Tc-HYNIC-TATE formulated using kits. Clinical utility of 99m Tc-HYNIC-TATE prepared using kits was demonstrated in patients with histopathologically confirmed well-differentiated NETs. Results: Pharmaceutical grade HYNIC-TATE kits compliant with all the quality control criteria were formulated and successfully radiolabeled with 99m Tc. Radiopharmaceutical was successfully utilized for detection of NETs in patients and comparison with uptake of 99m Tc-HYNIC-TOC and 177 Lu-DOTA-TATE was made. Conclusion: The formulated kits are robust and provide consistently high radiolabeling yields (> 95%) with 99m Tc in short time periods requiring no additional purification. Initial clinical trials demonstrate the utility of 99m Tc-HYNIC-TATE using formulated kits. Highlights: Pharmaceutical grade HYNIC-TATE kits compliant with quality control criteria were formulated. 99m Tc-HYNIC-TATE was successfully prepared with > 95% RCP using the formulated kits. Radiopharmaceutical was successfully utilized for detection of NETs in patients.