This project aims to monitor the innocuity/safety profile of cyclotron-produced [68Ga]-PSMA-617 PET imaging in PSMA-expressing cancers. It is a single-site, pragmatic, non-randomized and open-label study, with no control group. Although prostate cancers constitute the usual recommended population for this PET modality, recent evidences suggest that most solid tumors express substantial amount of PSMA in their neovasculature. As such, all cancers (excluding non-solid cancers) will be eligible for [68Ga]-PSMA-617 PET imaging in this trial, for as long as their tumors express PSMA.
This study also aims to instigate the use of [68Ga]-PSMA-617 in the routine standard-of-care for detection and follow-up of eligible cancers. FInally, this project seeks to gather information about the impact on patient management this novel PET modality will have over the current standard-of-care.

开始日期2022-01-21

申办/合作机构

Centre Hospitalier Universitaire de Sherbrooke

NCT05841992

/ Unknown status临床2/3期IIT

Comparison of the Detection Efficiencies of Al18F-PSMA-617 and 68Ga-PSMA-617 PET/CT in Patients With Prostate Cancer

18F-labeled prostate-specific membrane antigen (PSMA) ligand-positron emission tomography (PET) offers advantages over 68Ga-labeled PSMA ligands. Al18F-PSMA-617 is a novel 18F-PSMA compound used for prostate cancer (PCa) imaging. This pilot study was prospectively designed to compare the lesion detectability of Al18F-PSMA-617 and related 68Ga-PSMA-617 PET/CT in patients with PCa

开始日期2021-07-01

申办/合作机构

北京协和医院

NCT04796467

/ Unknown status临床2/3期IIT

A Pilot Prospective Comparison of 68Ga-P16-093 and 68Ga-PSMA-617 in the Same Group of Prostate Cancer Patients

Prostate-specific membrane antigen (PSMA)-targeted PET imaging with 68Ga-labeled compounds is able to provide superior sensitivity and specificity to detect primary prostate tumor and its metastases, like the widely studied 68Ga-PSMA-617. This pilot study was prospectively designed to evaluate the early dynamic distribution of 68Ga-P16-093, a novel radiopharmaceutical targeting PSMA, which was compared with 68Ga-PSMA-617 in the same group of prostate cancer patients.

开始日期2020-10-01

申办/合作机构

北京协和医院

100 项与 Gallium-68 PSMA-617 相关的临床结果

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100 项与 Gallium-68 PSMA-617 相关的转化医学

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100 项与 Gallium-68 PSMA-617 相关的专利（医药）

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项与 Gallium-68 PSMA-617 相关的文献（医药）

2025-09-25·JOURNAL OF MEDICINAL CHEMISTRY

A Novel Type of PSMA-Targeting Ligands via β-Branched Aromatic α-Amino Acid Modification, Bearing Enhanced Tumor Targeting and Reduced Renal Toxicity

Article

作者: Wang, Rui ; Hu, Kuan ; Zhang, Siqi ; Chen, Xueyao ; Gao, Xin ; Yang, Li-Cheng ; Xing, Chunxiao ; Liu, Zong-Xiao

We designed and synthesized a novel type of PSMA radioligand incorporating (2S, 3R) β-branched aromatic α-amino acids within the linker segment of its structure. In vivo PET/CT imaging and biodistribution analysis revealed that β-branched aromatic α-amino acids modified PSMA radioligands could maintain or even improve tumor targeting while exhibiting a more rapid renal clearance rate than [⁶⁸Ga]Ga-PSMA-617. With average renal uptake of less than 10%ID/g, as opposed to 25%ID/g for [⁶⁸Ga]Ga-PSMA-617, this substantial decrease in renal accumulation translates to a significantly improved safety profile by minimizing nephrotoxic risks. Our findings establish (2S,3R) β-branched aromatic α-amino acids as multifunctional pharmacophores that simultaneously enhance two critical performance parameters: target-binding affinity and renal clearance efficiency. Notably, [⁶⁸Ga]Ga-PSMA-Y55 emerged as the lead compound, exhibiting an optimal balance of high tumor uptake and low renal accumulation, rendering it a promising candidate for next-generation prostate cancer radioligand therapy.

2025-06-17·PROCEEDINGS OF THE NATIONAL ACADEMY OF SCIENCES OF THE UNITED STATES OF AMERICA

Development of an in situ CAR-T cell protocol through optical and PSMA-targeted PET imaging

Article

作者: Wang, James ; Engudar, Gokce ; Guo, Yutong ; Jan, Basit L. ; Minn, Il ; Seo, Jai Woong ; Tumbale, Spencer K. ; Czerwinski, Debra K. ; Ferrara, Katherine W. ; Kim, Ha Rin ; Pomper, Martin G. ; Robinson, Elise ; Sallets, Adrienne ; Raie, Marina N. ; Levy, Ronald ; Zhang, Nisi ; Rivera-Rodriguez, Angelie

In situ T cell transfection methods overcome the complexity and high costs associated with conventional chimeric antigen receptor (CAR)-T therapy. However, the in situ CAR-T cell approach operates within the patient’s complex immune environment and bypasses preinfusion ex vivo cellular quality controls, necessitating advanced imaging techniques to track immune cell migration and function. Positron emission tomography (PET) can detect biochemical processes in patients and, when combined with a radiotracer specific for the engineered cells, can monitor CAR-T cell trafficking. Herein, we develop an approach for in situ T cell generation, tracking, and functional assessment using anti-CD5-conjugated lipid nanoparticles for codelivering CD19 CAR mRNA (mCAR19) and a prostate-specific membrane antigen mRNA (mPSMA) tag. With interleukin-7 (IL-7) preconditioning and repeated administration, this approach achieves tumor-free survival in 75% of B cell lymphoma-bearing mice (similar efficacy to ex vivo approaches), and through PET imaging of 68 Ga-PSMA-617, the generation and tumor infiltration of in situ-engineered PSMA-tagged CD19 CAR-T cells is validated.

2024-09-01·Current radiopharmaceuticals

“One Method to Label Them All”: A Single Fully Automated Protocol for GMP-Compliant ⁶⁸Ga Radiolabeling of PSMA-11, Transposable to PSMA-I&T and PSMA-617

Article

作者: Deshayes, Emmanuel ; Rubira, Léa ; Fersing, Cyril ; Santoro, Lore ; Fouillet, Juliette ; Donzé, Charlotte

Background:::

Prostate-specific membrane antigen (PSMA) is an ideal target for molecular imaging and targeted radionuclide therapy in prostate cancer. Consequently, various PSMA ligands were developed. Some of these molecules are functionalized with a chelator that can host radiometals, such as 68Ga for PET imaging. The 68Ga radiolabeling step benefits from process automation, making it more robust and reducing radiation exposure.

Objective:::

To design a single automated radiolabeling protocol for the GMP-compliant preparation of [68Ga]Ga-PSMA-11, transposable to the production of [68Ga]Ga-PSMA-617 and [68Ga]Ga-PSMA-I&T.

Methods:::

A GAIA® synthesis module and a GALLIAD® generator were used. Radio-TLC and radio-HPLC methods were validated for radiochemical purity (RCP) determination. Three [68Ga]Ga-PSMA-11 validation batches were produced and thoroughly tested for appearance and pH, radionuclide identity and purity, RCP, stability, residual solvent and sterility. Minimal modifications were made to the reagents and disposables for optimal application to other PSMA ligands.

Results:::

[68Ga]Ga-PSMA-11 for clinical application was produced in 27 min. The 3 validation batches met the quality criteria expected by the European Pharmacopoeia to allow routine production. For optimal transposition to PSMA-617, the solid phase extraction cartridge was changed to improve purification of the radiolabeled product. For application to PSMA-I&T, the buffer solution initially used was replaced by HEPES 2.7 M to achieve good radiochemical yields. Residual HEPES content was checked in the final product and was below the Ph. Eur. threshold.

Conclusion:::

A single automated radiolabeling method on the GAIA® module was developed and implemented for 68Ga radiolabeling of 3 PSMA ligands, with slight adjustments for each molecule.

项与 Gallium-68 PSMA-617 相关的新闻（医药）

2025-11-28

·拓展生命无限可能

【I/II期临床试验】新型放射性药物177Lu-NYM032注射液招募PSMA阳性的经治转移性去势抵抗性前列腺癌患者！

#前列腺癌放射疗法临床试验 #177Lu—NYM032 #PSMA靶向治疗核药 #前列腺癌放射疗法临床招募简要入排本临床药物为新一代PSMA靶向治疗核药；目前招募转移性去势抵抗性前列腺癌（mCRPC）患者；血清睾酮<50 ng/dL或1.7nmol/L；在mCRPC阶段必须接受过至少1种新型内分泌治疗及至少1种但不超过2种紫杉类药物为基础的化疗方案或无法耐受或拒绝接受紫杉类药物；68Ga-NYM032 PET/CT显像阳性；排除骨扫描时观察到超级骨显像的患者；排除有脑转移症状或有检查结果证实存在脑转移的患者。研究中心江苏无锡具体启动情况以后期咨询为准【研究中心若有更新请拉至文末查看】试验名称一项评价放射性177Lu注射液在PSMA阳性的转移性去势抵抗性前列腺癌患者中的安全性、药代动力学/辐射剂量学和有效性的I/II期临床研究。试验药物前列腺特异性膜抗原（PSMA）是一种跨细胞膜表达的细胞膜表面蛋白，又名谷氨酸羧肽酶II（GCPII），其可能在癌细胞的增殖和肿瘤进展中起相当重要的作用。 177Lu-NYM032注射液是一款具备前列腺特异性膜抗原（PSMA）高亲和力的小分子化合物，是诺宇医药在研诊疗一体化核药NY108（NYM032）管线中的治疗型核药，适应症为转移性去势抵抗性前列腺癌（mCRPC），与该管线的诊断型核药68Ga-NY108（NYM032）为同一前体结构。相较于国外同类型产品，该药物前期研究者发起的临床研究（IIT）结果显示基于诺宇医药全新技术平台开发的NY108在肿瘤内滞留的时间更长（t1/2 eff超过168小时）、循环清除更快、肿瘤摄取更高，177Lu-NYM032注射液有望成为新一代PSMA靶向治疗核药，并将进一步提升前列腺癌核素治疗的安全性、有效性、经济性。在核医学顶级期刊EJNMMI披露的相关数据中表明，68Ga/177Lu-NYM032作为一种新型的诊疗一体化放射性药物，展现出较好的安全性和有效性。68Ga-NYM032相较68Ga-PSMA617具备更高的肿瘤摄取率和靶本比；177Lu-NYM032在肿瘤中的滞留时间更长，且在血液循环、正常组织器官代谢快，初步临床药效研究提示其可以以相对较低的放射性剂量（15-30 mCi）达到一定的治疗效果。研究药物：177Lu-NYM032注射液（I/II期）登记号：CTR20241097 试验类型：单臂试验适应症：转移性去势抵抗性前列腺癌（二线及以上）申办方：无锡诺宇医药科技有限公司延伸阅读无锡诺宇医药科技有限公司成立于2021年，是一家专注于原研创新诊疗一体化放射性药物的生物医药企业。在“快速概念验证”和“快速商业化”的双轮策略驱动下，公司聚焦以泌尿系统肿瘤、消化道肿瘤等临床未被满足的需求，围绕全新靶点First in Class和成熟靶点Best in Class两个维度进行战略布局开发中国原研创新核药。公司拥有一支自药物发现至商业化领域经验丰富、背景深厚的核医药专业团队（近百人规模），已建立起快速高通量的临床前和临床筛选体系，完成了数十个靶点的筛选及临床开发策略验证工作。备注：以上信息来源于网络注：上下滑动可查看全部内容用药周期 177Lu-NYM032注射液的规格：200mCi；用法用量：50~200mCi；用药时程：6周为1个给药周期，共给药4~6个周期。入选标准 1、能够理解并愿意签署书面知情同意书，年龄满18周岁及以上的男性。 2、①经组织学、病理学和/或细胞学证实为前列腺癌；②血清睾酮<50 ng/dL或1.7nmol/L。 3、68Ga-NYM032 PET/CT显像阳性。 4、ECOG评分0-2，预计生存期3月及以上。 5、在mCRPC阶段必须接受过至少1种新型内分泌治疗及至少1种但不超过2种紫杉类药物为基础的化疗方案或无法耐受或拒绝接受紫杉类药物的患者。 6、必须有正常的器官和骨髓功能。排除标准 1、既往其他肿瘤病史或现患有其他肿瘤疾病的；给药前4周内接受过全身抗肿瘤的药物、器械或放射治疗或参加临床试验。 2、既往使用过全身或局部的放射性同位素治疗。 3、有脑转移症状或有检查结果证实存在脑转移的。 4、有症状的脊髓压迫，或提示即将发生脊髓压迫的临床或影像学结果。 5、涉及心脏、呼吸、中枢神经系统、肾脏、肝脏或血液器官系统的疾病，明显妨碍本研究的完成或干扰本研究中任何不良时间因果关系的确定。 6、根据NCI CTCAEV5.0判定，既往抗肿瘤治疗的任何毒性反应未恢复至0-1级。 7、在研究期间和最后一次研究用药后6个月内，有生育潜力的但不愿意使用可接受的节育方法。 8、骨扫描时观察到超级骨显像。 9、可能影响研究完成（包括依从性不佳）或不适合使用试验用药品的疾病、精神状态或手术情况。更多项目信息请参考： http://www.chinadrugtrials.org.cn/index.html 温馨提示：文章入排信息来源于国家临床试验官网公示信息，具体情况以实际咨询为准！报名方式参与临床试验，获取国际前沿新药新疗法使用机会！更有一线专家团队为你的治疗保驾护航！【印塔健康】目前有肺癌、肝癌、肾癌、胃癌、肠癌、胰腺癌、妇瘤、泌尿肿瘤、血液肿瘤......等几乎涵盖所有癌种的临床试验正在招募患者！扫描下方二维码添加医学运营一对一咨询或点击左下角“阅读原文”直接报名！我们将会在24小时内（工作日）与您电话或微信联系，请保持手机畅通！【重要提示】印塔健康旗下公众号【拓展生命无限可能】所有文章信息仅供参考，具体治疗谨遵医嘱！ 177Lu-LNC1011注射液招募前列腺癌 ADC新药XNW28012招募前列腺癌 CYP11A1抑制剂INV-9956招募前列腺癌

放射疗法临床结果临床3期临床2期

100 项与 Gallium-68 PSMA-617 相关的药物交易

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研发状态

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适应症	最高研发状态	国家/地区	公司	日期
前列腺腺癌	临床3期	中国	北京协和医院	2020-10-01
转移性前列腺癌	临床2期	法国	-	2018-04-25
复发性前列腺癌	临床2期	法国	-	2018-04-25
前列腺癌	临床阶段不明	-	German Cancer Research Center	-
前列腺癌	临床阶段不明	-	Ruprecht-Karls-Universität Heidelberg	-

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


SNMMI2024	N/A	-	-	PSMA-RLT (3TMPO A RLT eligibility criteria)	壓膚廠築蓋選網遞鑰網(願鑰鹹遞簾夢繭蓋鹽築) = 憲壓鏇簾簾蓋獵窪壓蓋窪願網鏇艱淵網鹽壓夢 (艱鑰簾齋膚壓壓壓夢憲, 8.5 ~ 11.8)	-	2024-06-09
SNMMI2022	临床2期	局限性前列腺癌 Prostate-Specific Membrane Antigen (PSMA) \| Gastrin-Releasing Peptide Receptor (GRP-R)	22	[68Ga]Ga-PSMA-617 (68Ga]Ga-PSMA-617 PET/CT)	鏇鑰鏇膚製製壓鹽鬱淵(艱艱鏇艱醖選積壓積範) = 製夢繭顧膚積積鬱糧鹽願願顧鹽憲齋網鹽廠願 (積壓鏇窪簾餘鑰壓範遞 )	积极	2022-08-08
SNMMI2022	临床2期		22	[68Ga]Ga-PSMA-617 (68Ga]Ga-RM2 PET/CT)	鏇鑰鏇膚製製壓鹽鬱淵(艱艱鏇艱醖選積壓積範) = 艱鏇構遞鬱鹹襯顧夢鹹願願顧鹽憲齋網鹽廠願 (積壓鏇窪簾餘鑰壓範遞 )	积极	2022-08-08
NCT04796467 (Pubmed \| Eur J Nucl Med Mol Imaging)	临床2/3期	复发性前列腺癌	20	[68Ga]Ga-PSMA-617	範窪蓋築顧簾淵醖鬱鏇(簾簾鏇齋蓋糧蓋蓋遞繭) = 壓築糧積膚願築築窪遞鑰蓋積襯觸衊鬱積鹽襯 (膚積獵糧顧鑰鏇構構鏇 ) 更多	-	2022-02-01