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

IF 1.5 3区 化学 Q3 CHEMISTRY, ANALYTICAL
Shakera Khatoon Rizvi, Saima Tariq, Farkhanda Gilani, Amna Javed, Iqra Rafique
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引用次数: 0

Abstract

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).

Graphical Abstract

Abstract Image

在巴基斯坦自行生产用于诊断神经内分泌肿瘤的[99m锝][Tc-HYNIC-TATE]冷试剂盒:对本国生产的单瓶和双瓶试剂盒配方进行临床前和临床评估
与用 In-111 和 Tc-99m 标记的辛孕肽 (NOC) 相比,神经内分泌肿瘤 (NET)。本研究的目的是在巴基斯坦本土开发易于使用、具有成本效益和商业化的[99mTc][Tc-HYNIC-TATE](Tyr3-Octreotate)诊断试剂盒,用于诊断神经内分泌肿瘤。HYNIC-TATE冷试剂盒采用EDDA/TRICINE(3:6 mg)共配体交换标记法,在90°C下加热20分钟,肽(Octreotate)含量优化为20µg。临床前和临床研究验证了所开发试剂盒在定点检测神经内分泌肿瘤(NET)方面具有更高的灵敏度和特异性。
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来源期刊
CiteScore
2.80
自引率
18.80%
发文量
504
审稿时长
2.2 months
期刊介绍: An international periodical publishing original papers, letters, review papers and short communications on nuclear chemistry. The subjects covered include: Nuclear chemistry, Radiochemistry, Radiation chemistry, Radiobiological chemistry, Environmental radiochemistry, Production and control of radioisotopes and labelled compounds, Nuclear power plant chemistry, Nuclear fuel chemistry, Radioanalytical chemistry, Radiation detection and measurement, Nuclear instrumentation and automation, etc.
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