PSMA显像剂Al^(18)F-PSMA-BCH的自动化合成及初步临床验证

Automated Synthesis and Preliminary Clinical Validation of Al^(18)F-PSMA-BCH for Prostate Cancer Imaging

目的使用AllinOne合成模块自动化合成前列腺特异性膜抗原(prostate specific membrane antigen,PSMA)显像剂Al^(18 )F-PSMA-BCH,并进行初步临床验证。方法在AllinOne合成模块上,以PSMA-BCH为前体,在醋酸-醋酸钠缓冲溶液体系中,与氟-18离子及AlCl_(3)溶液在高温下反应后再经纯化得到Al^(18)F-PSMA-BCH产品,并对产品进行质量控制检测。同时,对1例前列腺癌患者行Al^(18)F-PSMA-BCH PET/CT扫描。结果Al^(18)F-PSMA-BCH合成时间为32min,不校正合成效率为(34.88±3.11)%(n=6),产品放射化学纯度大于95%。前列腺癌患者Al^(18)F-PSMA-BCH PET/CT显像可见前列腺放射性摄取弥漫不均匀异常增高伴盆腔多发淋巴结转移,多发骨转移。结论AllinOne合成模块自动化合成Al^(18)F-PSMA-BCH简单快捷、重复性好,制备出的Al^(18)F-PSMA-BCH产品质量符合临床要求,为推动Al^(18)F-PSMA-BCH在临床上的应用提供支持。

Objective Prostate specific membrane antigen(PSMA)imaging agent Al^(18)F-PSMA-BCH was synthesized automatically using AllinOne synthesis module and the clinical imaging of Al^(18)F-PSMA-BCH was evaluated.Methods For the AllinOne synthesis module,PSMA-BCH was used as the precursor,which reacted with ^(18)F ion and AlCl_(3) solution in sodium acetate-acetic acid buffer at a high temperature,and then was purified to obtain Al^(18)F-PSMA-BCH product.The corresponding test of quality controls of the product Al^(18)F-PSMA-BCH were performed.One case of patient with prostate cancer then underwent Al^(18)F-PSMA-BCH PET/CT scaning.Results It took 32 min utes for the processing duration of ^(18)Fions to Al^(18)F-PSMA-BCH,and no-corrected efficiency was(34.88±3.11)%(n=6),while radiochemistry purity was over 95%.Al^(18)F-PSMA-BCH PET/CT imaging of the patient showed a diffuse,uneven and abnormal increase of radioactive uptake of the prostate,accompanied by multiple pelvic lymph node metastasis and multiple bone metastasis.Conclusion The automated synthesis of Al^(18)F-PSMA-BCH by AllinOne synthesis module is a simple,fast and has a good repeatability.The quality of the Al^(18)F-PSMA-BCH product can meet the requirements for clinical practices,which provides a good support for promoting the clinical application of Al^(18)F-PSMA-BCH.