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评估基于试剂盒的68Ga-泛杀素制剂在感染诊断中的潜力:一项68Ga的初步研究

Evaluating the potential of kit-based 68Ga-ubiquicidin formulation in diagnosis of infection: a pilot study68Ga.

作者信息

Bhusari Priya, Bhatt Jyotsna, Sood Apurva, Kaur Ruchikapreet, Vatsa Rakhee, Rastogi Ashu, Mukherjee Archana, Dash Ashutosh, Mittal Bhagwant Rai, Shukla Jaya

机构信息

Department of Nuclear Medicine and PET, Post Graduate Institute of Medical Education and Research, Chandigarh.

Division of Radiopharmaceuticals, Bhabha Atomic Research Centre, Mumbai, Maharashtra, India.

出版信息

Nucl Med Commun. 2019 Mar;40(3):228-234. doi: 10.1097/MNM.0000000000000943.

DOI:10.1097/MNM.0000000000000943
PMID:30480552
Abstract

OBJECTIVE

The aim was to evaluate the diagnostic potential of Ga-ubiquicidin positron-emission tomography/computed tomography (PET/CT) in imaging patients with infection.

MATERIALS AND METHODS

Ga-NOTA-ubiquicidin (Ga-UBI) was prepared by addition of freshly eluted Ga-chloride from Ge/Ga generator into the NOTA-ubiquicidin vial and incubated at room for 15 min at 90°C. After compounding of the radiopharmaceutical, quality control using instant thin-layer chromatography, culture and endotoxin estimation was performed. Patients with suspected infection associated with diabetic foot, cellulitis and fracture were selected for the pilot study investigation to evaluate the ability of the tracer Ga-UBI in localization at infection sites. The PET/CT findings were compared with other diagnosis like microbial culture reports and bone scintigraphy to evaluate true positives or negatives in the study.

RESULTS

The current study demonstrated the potential of kit-based Ga-UBI in localization of infection sites in most of the patients proven positive for infection on culture tests and bone scintigraphy. The kit could offer radiolabeling yield more than 95% in 15 min incubation at 90°C. Quality control rendered the kit as a clinical grade preparation with endotoxin content less than 10 EU/ml and sterility up to 14 days of culture incubation. Eight of 10 patients underwent culture test and showed positive results. Two patients had undergone three-phase bone scan as an indirect sign of active infection. Ga-UBI PET/CT showed tracer localization in four of eight culture-positive patients. Tracer localization was observed in one of two patients whose culture reports were not available. Ga-UBI failed to identify infection in four patients with culture-positive results.

CONCLUSION

The present study concluded that Ga-UBI prepared using NOTA-UBI kit is a potential agent in targeting infections associated with disease conditions including diabetic foot, cellulitis and fracture. The patient selection holds significance in accurate diagnosis using Ga-UBI PET/CT.

摘要

目的

评估镓-泛菌素正电子发射断层扫描/计算机断层扫描(PET/CT)对感染患者成像的诊断潜力。

材料与方法

通过将从锗/镓发生器中新鲜洗脱的氯化镓加入到NOTA-泛菌素小瓶中制备镓-NOTA-泛菌素(Ga-UBI),并在90°C下于室温孵育15分钟。制备放射性药物后,使用即时薄层色谱法、培养和内毒素评估进行质量控制。选择患有与糖尿病足、蜂窝织炎和骨折相关的疑似感染患者进行初步研究调查,以评估示踪剂Ga-UBI在感染部位定位的能力。将PET/CT结果与微生物培养报告和骨闪烁显像等其他诊断方法进行比较以评估研究中的真阳性或真阴性。

结果

当前研究表明,基于试剂盒的Ga-UBI在大多数经培养试验和骨闪烁显像证实感染呈阳性的患者中具有定位感染部位的潜力。该试剂盒在90°C下孵育15分钟时可提供超过95%的放射性标记产率。质量控制使该试剂盒成为一种临床级制剂,内毒素含量低于10 EU/ml且在培养孵育14天内无菌。10名患者中有8名接受了培养试验,结果呈阳性。2名患者进行了三相骨扫描作为活动性感染的间接征象。Ga-UBI PET/CT在8名培养阳性患者中的4名中显示示踪剂定位。在2名培养报告不可用的患者中的1名中观察到示踪剂定位。Ga-UBI未能识别4名培养结果呈阳性患者的感染。

结论

本研究得出结论,使用NOTA-UBI试剂盒制备的Ga-UBI是一种潜在的药物,可用于靶向与包括糖尿病足、蜂窝织炎和骨折在内的疾病相关的感染。患者选择对于使用Ga-UBI PET/CT进行准确诊断具有重要意义。

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