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-

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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15

项与 Gallium-68 PSMA-617 相关的文献（医药）

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.

2023-04-01·Clinical Nuclear Medicine

Head-to-Head Comparison of 68Ga-P16-093 and 68Ga-PSMA-617 PET/CT in Patients With Primary Prostate Cancer

Article

作者: Hong, Haiyan ; Zang, Jie ; Kung, Hank F ; Wang, Guochang ; Zhu, Lin ; Zhu, Zhaohui ; Li, Linlin

PurposeWe aimed to compare the diagnostic performance of 68Ga-P16-093 and 68Ga-PSMA-617 PET/CT in primary prostate cancer (PCa) patients.Patients and MethodsThirty untreated primary PCa patients were enrolled. Each patient underwent 68Ga-P16-093 and 68Ga-PSMA-617 PET/CT within a week. In addition to visual analysis, SUV was measured for semiquantitative comparison and correlation analysis.Results68Ga-P16-093 PET/CT detected more positive tumors than 68Ga-PSMA-617 PET/CT (67 vs 56, P = 0.002), especially for intraprostatic lesions (29 vs 24, P = 0.025) and lymph node metastases (23 vs 17, P = 0.034). Further, 68Ga-P16-093 PET/CT exhibited significantly higher SUVmax of matched tumors (18.3 ± 14.4 vs 13.9 ± 11.8, P < 0.001). Besides, the SUVmax of high-risk patients (based on D’Amico classification) on 68Ga-P16-093 PET/CT was significantly higher than that of low- and intermediate-risk PCa patients (20.9 ± 9.9 vs 8.9 ± 9.1 vs 10.1 ± 5.2, P = 0.007). The SUVmax of tumor measured by 68Ga-P16-093 PET/CT had a moderate association with biopsy Gleason score (r = 0.462, P = 0.005) and prostate-specific antigen value (r = 0.491, P = 0.002), and significantly correlated with PSMA expression (r = 0.732, P < 0.001).Conclusions68Ga-P16-093 PET/CT exhibited higher tumor uptake and potentially better tumor detection capability than 68Ga-PSMA-617 PET/CT, which suggested that 68Ga-P16-093 may be more suitable in the diagnosis and staging of primary PCa patients.

2023-03-01·Journal of Nuclear Medicine

Comparison of⁶⁸Ga-PSMA-617 PET/CT and⁶⁸Ga-RM2 PET/CT in Patients with Localized Prostate Cancer Who Are Candidates for Radical Prostatectomy: A Prospective, Single-Arm, Single-Center, Phase II Study

Article

作者: Schollhammer, Romain ; Gallerande, Henri de Clermont ; Balamoutoff, Nicolas ; Robert, Grégoire ; Bladou, Franck ; Vimont, Delphine ; Asselineau, Julien ; Bénard, Antoine ; Morgat, Clément ; Yacoub, Mokrane ; Hindié, Elif

Considering the wide range of therapeutic options for localized prostate cancer (e.g., active surveillance, radiation-beam therapy, focal therapy, and radical prostatectomy), accurate assessment of the aggressiveness and localization of primary prostate cancer lesions is essential for treatment decision making. National Comprehensive Cancer Network guidelines recognize prostate-specific membrane antigen (PSMA) PET/CT for use in initial staging of high-risk primary prostate cancer. The gastrin-releasing peptide receptor (GRP-R) is a neuropeptide receptor overexpressed by low-risk prostate cancer cells. We aimed to perform the first (to our knowledge) prospective head-to-head comparison of PSMA- and GRP-R-targeted imaging at initial staging to understand how PSMA PET and GRP-R PET can be used or combined in clinical practice. Methods: This was a prospective, single-center, diagnostic cross-sectional imaging study using anonymized, masked, and independent interpretations of paired PET/CT studies in 22 patients with ⁶⁸Ga-PSMA-617 (a radiolabeled PSMA inhibitor) and ⁶⁸Ga-RM2 (⁶⁸Ga-DOTA-4-amino-1-carboxymethylpiperidine-d-Phe-Gln-Trp-Ala-Val-Gly-His-Sta-Leu-NH2, a radiolabeled GRP-R antagonist). We enrolled patients with newly diagnosed, biopsy-proven prostate cancer. None had received neoadjuvant hormone therapy or chemotherapy, and all underwent extended pelvic lymph node dissection. Histologic findings served as a reference. Results: On a lesion-based analysis (including lesions < 0.1 cm³), ⁶⁸Ga-PSMA-617 PET/CT detected 74.3% (26/35) of all tumor lesions and ⁶⁸Ga-RM2 PET/CT detected 78.1% (25/32; 1 patient could not be offered ⁶⁸Ga-RM2 PET/CT). Paired examinations showed positive uptake of the 2 tracers in 21 of 32 lesions (65.6%), negative uptake in 5 of 32 lesions (15.6%), and discordant uptake in 6 of 32 lesions (18.8%). Uptake of ⁶⁸Ga-PSMA-617 was higher when the International Society of Urological Pathology (ISUP) score was at least 4 versus at least 1 (P < 0.0001) or 2 (P = 0.0002). There were no significant differences in uptake between ISUP scores for ⁶⁸Ga-RM2. Median ⁶⁸Ga-RM2 SUV_max was significantly higher than median ⁶⁸Ga-PSMA-617 SUV_max in the ISUP-2 subgroup (P = 0.01). Conclusion: ⁶⁸Ga-PSMA-617 PET/CT is useful to depict higher, more clinically significant ISUP score lesions, and ⁶⁸Ga-RM2 PET/CT has a higher detection rate for low-ISUP tumors. Combining PSMA PET and GRP-R PET allows for better classification of intraprostatic lesions.

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


SNMMI2020	N/A	-	-	68 Ga-PSMA-61768Ga-PSMA-617 (Cyclotron-produced 68Ga-PSMA-617)	鑰膚積網鑰構鑰顧蓋襯(餘鹹網窪艱遞鏇窪鹽觸) = >95% 衊鹽鬱網衊觸顧網鹽膚 (鹹簾鹽顧願淵淵網窪範 ) 更多	-	2020-05-15
SNMMI2020	N/A	-	-	68Ga-PSMA-617	簾糧簾選憲積餘獵遞繭(觸觸蓋選鹹淵選鏇膚餘) = 鹽選鑰選糧憲齋鹹鹽齋鬱鹽顧夢鑰餘鏇鏇艱觸 (範願鏇鏇鑰膚積積繭膚 ) 更多	-	2020-05-15