Gallium-68 PSMA-617(Gallium-68 PSMA-617) - 药物靶点：PSMA_在研适应症：前列腺腺癌，前列腺癌_专利_临床

概要

基本信息

药物类型

多肽偶联核素、诊断用放射药物

别名

+ [3]

靶点

PSMA

作用方式

抑制剂

作用机制

PSMA抑制剂(前列腺癌特异性膜抗原抑制剂)

治疗领域

肿瘤泌尿生殖系统疾病

在研适应症

前列腺腺癌前列腺癌

非在研适应症

转移性前列腺癌复发性前列腺癌

原研机构

Ruprecht-Karls-Universität Heidelberg

在研机构

German Cancer Research Center

Ruprecht-Karls-Universität Heidelberg北京协和医院

非在研机构-

权益机构-

最高研发阶段临床2/3期

首次获批日期-

最高研发阶段(中国)临床2/3期

特殊审评-

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结构/序列

分子式C49H66GaN9O16

InChIKeyPAXMZYRHVDZFFV-VSVMWJISSA-I

CAS号2247839-19-4

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关联

6

项与 Gallium-68 PSMA-617 相关的临床试验

NCT06437496

/ Recruiting早期临床1期IIT

68Ga-AAZTA-093 PET/CT: First-in-human Study in Patients With Prostate Cancer

68Ga-AAZTA-093 is a novel radiotracer targeting prostate-specific membrane antigen (PSMA). In this study, we observed the safety, biodistribution, radiation dosimetry and diagnostic value of 68Ga-AAZTA-093 PET/CT in patients with prostate cancer.

开始日期2024-04-01

申办/合作机构

福建医科大学附属第一医院

NCT05228106

/ RecruitingN/AIIT

Pragmatic Study on the Use of 68Ga-PSMA-617 PET/CT Imaging as a Standard of Care to Influence Clinical Management of Tumors Overexpressing PSMA.

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

/ Recruiting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

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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20

项与 Gallium-68 PSMA-617 相关的文献（医药）

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

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.

2024-02-23·Journal of Leukocyte Biology

Construction of truncated PSMA as a PET reporter gene for CAR T cell trafficking

Article

作者: Long, Yu ; Lv, Xiaoying ; Xu, Zhuoshuo ; Zhang, Yirui ; Song, Xiangming ; Lan, Xiaoli ; Lei, Ping

AbstractIn solid tumors, there are multiple barriers for a chimeric antigen receptor (CAR) T cell to surmount in order to reach the tumor site. For better understanding whether CAR T cells effectively infiltrate into tumor site, and simultaneously, whether there are off-target effects, real-time monitoring technologies need to be established. Cell-based positron emission tomography reporter genes have been developed to monitor engineered cells in living subjects. In this study, we reported the construction of a novel reporter gene truncated prostate-specific membrane antigen (ΔPSMA) pending for monitoring CAR T cells using 68Ga-PSMA-617 and a method for tracking the distribution of CAR T cells in vivo was developed. Data were provided to demonstrate that ΔPSMA was predominantly localized on the plasma membrane and could take up 68Ga-PSMA-617 in vitro in a time-dependent manner. And the expression of ΔPSMA did not affect CAR expression and cytolytic capacity of CAR T cells. CAR-ΔPSMA T cell xenografts in nude mice were clearly imaged by positron emission tomography 60 min after injection of 68Ga-PSMA-617. PSMA paired with 68Ga-PSMA-617 was capable of identifying approximately 1 × 104 engineered CAR T cells. The ability to image small numbers of CAR T cells in vivo would be helpful to accelerate the translation of cell-based therapies into the clinic, and it may reinforce our understanding of treatment success, failure, and toxicity.

2023-06-01·European Journal of Nuclear Medicine and Molecular Imaging

A prospective comparative study of [68Ga]Ga-RM26 and [68Ga]Ga-PSMA-617 PET/CT imaging in suspicious prostate cancer

Article

作者: Hu, Shuo ; Gan, Yu ; Li, Jian ; Yin, Hongling ; Chen, Minfeng ; Gao, Xiaomei ; Cai, Yi ; Zu, Xiongbin ; Tang, Yongxiang

PURPOSEProstate-specific membrane antigen (PSMA)-based PET/CT imaging has limitations in the diagnosis of prostate cancer (PCa). We recruited 207 participants with suspicious PCa to perform PET/CT imaging with radiolabeled gastrin-releasing peptide receptor (GRPR) antagonist, [⁶⁸Ga]Ga-RM26, and compare with [⁶⁸Ga]Ga-PSMA-617 and histopathology.METHODSEvery participant with suspicious PCa was scanned with both [⁶⁸Ga]Ga-RM26 and [⁶⁸Ga]Ga-PSMA-617 PET/CT. PET/CT imaging was compared using pathologic specimens as a reference standard.RESULTSOf the 207 participants analyzed, 125 had cancer, and 82 were diagnosed with benign prostatic hyperplasia (BPH). The sensitivity and specificity of [⁶⁸Ga]Ga-RM26 and [⁶⁸Ga]Ga-PSMA-617 PET/CT imaging differed significantly for detecting clinically significant PCa. The area under the ROC curve (AUC) was 0.54 for [⁶⁸Ga]Ga-RM26 PET/CT and 0.91 for [⁶⁸Ga]Ga-PSMA-617 PET/CT in detecting PCa. For clinically significant PCa imaging, the AUCs were 0.51 vs. 0.93, respectively. [⁶⁸Ga]Ga-RM26 PET/CT imaging had higher sensitivity for PCa with Gleason score (GS) = 6 (p = 0.03) than [⁶⁸Ga]Ga-PSMA-617 PET/CT but poor specificity (20.73%). In the group with PSA < 10 ng/mL, the sensitivity, specificity, and AUC of [⁶⁸Ga]Ga-RM26 PET/CT were lower than [⁶⁸Ga]Ga-PSMA-617 PET/CT (60.00% vs. 80.30%, p = 0.12, 23.26% vs. 88.37%, p = 0.000, and 0.524 vs. 0.822, p = 0.000, respectively). [⁶⁸Ga]Ga-RM26 PET/CT exhibited significantly higher SUVmax in specimens with GS = 6 (p = 0.04) and in the low-risk group (p = 0.01), and its uptake did not increase with PSA level, GS, or clinical stage.CONCLUSIONThis prospective study provided evidence for the superior accuracy of [⁶⁸Ga]Ga-PSMA-617 PET/CT over [⁶⁸Ga]Ga-RM26 PET/CT in detecting more clinically significant PCa. [⁶⁸Ga]Ga-RM26 PET/CT showed an advantage for imaging low-risk PCa.

100 项与 Gallium-68 PSMA-617 相关的药物交易

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研发状态

10 条进展最快的记录,

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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	临床申请	法国	-	2018-04-25
复发性前列腺癌	临床申请	法国	-	2018-04-25

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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


EANM2024	N/A	前列腺癌	38	Ga-PSMA-617 (mpMRI)	網願膚淵鑰積鬱憲鬱願(鹹遞蓋窪鹹願壓積顧餘) = 鹽醖鑰網鏇簾淵顧艱願淵選獵遞壓鑰網醖顧醖 (襯製網醖鹹衊遞襯積網 )	-	2024-09-27
EANM2024	N/A	前列腺癌	38	Ga-PSMA-617 (68Ga-RM26 PET)	網願膚淵鑰積鬱憲鬱願(鹹遞蓋窪鹹願壓積顧餘) = 糧淵壓衊鬱壓淵糧鹹網淵選獵遞壓鑰網醖顧醖 (襯製網醖鹹衊遞襯積網 )	-	2024-09-27
SNMMI2020	N/A	-	-	68Ga-PSMA-617	襯齋淵製獵鏇糧獵獵壓(廠鹽餘顧網顧構鏇觸衊) = 鑰鑰鏇獵艱簾鏇蓋積齋觸顧觸醖糧選獵築醖構 (獵範獵齋壓築膚餘醖範 ) 更多	-	2020-05-15
SNMMI2020	N/A	-	-	68 Ga-PSMA-61768Ga-PSMA-617 (Cyclotron-produced 68Ga-PSMA-617)	網糧鏇夢鏇窪顧簾觸獵(餘窪鏇觸範膚鏇選醖願) = >95% 鑰糧獵壓艱構簾遞窪願 (餘積醖鹹鏇艱壓壓衊顧 ) 更多	-	2020-05-15