[⁶⁸Ga]PSMA-11 for positron emission tomography (PET) imaging of prostate-specific membrane antigen (PSMA)-positive lesions in men with prostate cancer

Theranostics targeting prostate-specific membrane antigen (PSMA) represent a new targeted approach for prostate cancer care that combines diagnostic and therapeutic radiopharmaceuticals to diagnose and treat the disease. Positron emission tomography (PET) is the imaging method of choice and several diagnostic radiopharmaceuticals for quantifying PSMA have received FDA approval and are in clinical use. [⁶⁸Ga]Ga-PSMA-11 is one such imaging agent and the focus of this article. One beta-emitting radioligand therapy ([¹⁷⁷Lu]Lu-PSMA-617) has also received FDA approval for prostate cancer treatment, and several other alpha- and beta-emitting radioligand therapies are in clinical trials. Theranostics targeting PSMA in men with prostate cancer are discussed with a focus on use of [⁶⁸Ga]Ga-PSMA-11 for imaging PSMA-positive lesions in men with prostate cancer. The review covers [⁶⁸Ga]Ga-PSMA-11 manufacture, current regulatory status, comparison of [⁶⁸Ga]Ga-PSMA-11 to other imaging techniques, clinical updates, and emerging applications of artificial intelligence for [⁶⁸Ga]Ga-PSMA-11 PET. [⁶⁸Ga]Ga-PSMA-11 is used in conjunction with a PET/CT scan to image PSMA positive lesions in men with prostate cancer. It is manufactured by chelating precursor with⁶⁸Ga, either from a generator or cyclotron, and has regulatory approval around the world. It is widely used clinically in conjunction with radioligand therapies like [¹⁷⁷Lu]Lu-PSMA-617.以前列腺特异性膜抗原（prostate-specific membrane antigen, PSMA）为靶点的诊疗一体化（Theranostics）是前列腺癌诊疗领域的新型靶向手段，该技术将诊断与治疗用放射性药物相结合，用于疾病的诊断与治疗。正电子发射断层显像（Positron emission tomography, PET）是临床首选的成像方法，多款用于PSMA定量的诊断放射性药物已获得美国食品药品监督管理局（Food and Drug Administration, FDA）批准并投入临床应用。其中，[⁶⁸Ga]Ga-PSMA-11便是此类显像剂之一，亦是本文的核心探讨内容。一款β发射型放射性配体疗法[¹⁷⁷Lu]Lu-PSMA-617也已获FDA批准用于前列腺癌治疗，另有多款α、β发射型放射性配体疗法处于临床试验阶段。本文围绕前列腺癌患者的PSMA靶向诊疗一体化展开论述，重点阐述[⁶⁸Ga]Ga-PSMA-11在前列腺癌患者PSMA阳性病灶显像中的应用。本综述涵盖了[⁶⁸Ga]Ga-PSMA-11的制备工艺、当前监管状态、与其他成像技术的对比分析、临床最新进展，以及人工智能（artificial intelligence, AI）在[⁶⁸Ga]Ga-PSMA-11 PET显像中的新兴应用场景。[⁶⁸Ga]Ga-PSMA-11通常与PET/CT扫描联合使用，用于前列腺癌患者的PSMA阳性病灶成像。该显像剂通过将前体与⁶⁸Ga（可来自发生器或回旋加速器）进行螯合反应制备而成，已在全球范围内获得监管机构批准，并广泛应用于临床，常与[¹⁷⁷Lu]Lu-PSMA-617等放射性配体疗法联合使用。

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该数据集提供了一篇关于[68Ga]PSMA-11用于前列腺癌PSMA阳性病变PET成像的学术文章或补充材料，发布于2024年7月26日，内容涵盖该成像剂的制造、监管状态、临床比较及人工智能应用。数据集以Excel文件形式呈现，适用于医学和癌症研究领域，并采用开放获取的CC BY 4.0许可证。