In-house production of [^99mTc][Tc-HYNIC-TATE] cold kit for the diagnosis of neuroendocrine tumors in Pakistan: pre-clinical and clinical evaluation of indigenously manufactured single and dual vial kit formulation

Neuroendocrine tumors (NETs) as compared to its octreotide (NOC) counterpart when labeled with In-111 and Tc-99m. This study was aimed to develop easy to use, cost effective, and commercially available diagnostic kit of [^99mTc][Tc-HYNIC-TATE] (Tyr3-Octreotate) indigenously to diagnose neuroendocrine tumors in Pakistan. HYNIC-TATE cold kit was optimized at 20µg of peptide (Octreotate), following co-ligand exchange labeling approach using EDDA/TRICINE (3:6 mg) while heating at 90 °C for 20 min. Radiochemical purity of [^99mTc][Tc-HYNIC-TATE] was > 98 ± 0.14% when labeled with 550–850 MBq of Tc-99m and stable upto 12 h. Preclinical & clinical investigations validated the higher sensitivity and specificity of the developed kits for spot-on detection of neuroendocrine tumours (NETs).