[68Ga] Pentixafor([68Ga] Pentixafor) - 药物靶点：CXCR4_在研适应症：边缘区B细胞淋巴瘤，醛固酮增多症，肌层浸润性膀胱癌_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

Gallium (68Ga) boclatixafortide、PentixaFor、[68Ga]Ga-PentixaFor

+ [3]

靶点

CXCR4

作用方式

拮抗剂

作用机制

CXCR4拮抗剂(C-X-C基序趋化因子受体4拮抗剂)

治疗领域

肿瘤免疫系统疾病内分泌与代谢疾病+ [5]

在研适应症

边缘区B细胞淋巴瘤醛固酮增多症肌层浸润性膀胱癌+ [8]

非在研适应症

原发性中枢神经系统淋巴瘤继发性中枢神经系统淋巴瘤

原研机构

University of Iowa

在研机构

PentixaPharm GmbH

The Holden Comprehensive Cancer Center

University of Iowa

非在研机构-

权益机构-

最高研发阶段临床3期

首次获批日期-

最高研发阶段(中国)-

特殊审评孤儿药 (欧盟)

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结构/序列

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Sequence Code 525682907

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关联

26

项与 [68Ga] Pentixafor 相关的临床试验

NCT06246357

/ Recruiting临床2期IIT

Phase 2 Study Evaluating the Functional Status of the Adrenal Glands With [68Ga]Ga-PentixaFor in Hyperaldosteronism and Hypercortisolism

Background:
The adrenal glands are 2 small organs that sit on top of each kidney. They release hormones; these are chemicals that control how the body works. Tumors on or outside the adrenal glands are called functional if they release hormones; they are called nonfunctional if they do not. Doctors who treat adrenal tumors need to know which type a person has. Researchers want to find better ways to learn whether an adrenal tumor is functional.
Objective:
To see if a new radioactive tracer ([68Ga]Ga-PentixaFor) can make it easier to identify functional adrenal tumors with positron emission tomography (PET) scans.
Eligibility:
People aged 18 years and older with 1 or more adrenal tumors. They must have increased levels of the hormones aldosterone or cortisol. They must also be enrolled in at least 1 other related NIH study (protocols 19-DK-0066, 18-CH-0031, or 09-C-0242).
Design:
Participants will be screened. They may have imaging scans. Their ability to perform normal activities will be reviewed.
Participants will have one PET scan with the study tracer.
The tracer will be given through a tube attached to a needle inserted into a vein. Participants will receive the tracer 1 hour before the scan. They will lie still on a bed while a machine captures images of the inside of their body. The scan will take 45 to 90 minutes.
Participants heart rate, blood pressure, and rate of breathing will be checked before, during, and after the scan.
Participants will have a follow-up visit 3 days after their scan. This visit can be by phone, email, or in person.

开始日期2024-09-23

申办/合作机构

National Cancer Institute

NCT06478875

/ Not yet recruiting临床2期IIT

"Pilot Study for the Evaluation of [68Ga]Ga-PentixaFor PET Imaging for the Identification of Unilateral Adrenal Secretion of ALdosterON in Patients With Primary Aldosteronism"

PentixaFor radiolabeled with 68Gallium (68Ga) is a radiopharmaceutical targeting the CXC chemokine receptor 4 (CXCR4) receptor. The CXCR4 receptor is expressed in zona glomerulosa of the adrenal cortex and in aldosterone producing adenoma (APA). The objective of this study will be to evaluate in 25 patients if [68Ga]Ga-PentixaFor positron emission tomography ([68Ga]Ga-PTF-PET) imaging allows for the discrimination of patients with lateralized or non-lateralized secretion of aldosterone in adrenal glands classified based on adrenal vein sampling (AVS).

开始日期2024-06-01

申办/合作机构

Assistance Publique des Hôpitaux de Paris SA

[+1]

CTIS2022-500918-25-00

/ Recruiting临床3期

A pivotal phase 3 clinical trial to assess the diagnostic performance and safety of [68Ga]Ga-PentixaFor ([68Ga]Ga-PTF), a positron emission tomography (PET) imaging agent, versus [18F]FDG PET/CT imaging, for staging of patients with confirmed marginal zone lymphoma (MZL) exemplary for CXCR4-positive malignant lymphomas: a prospective, international, multi-center, comparative, randomized, cross-over, open-label lymphoma diagnostic trial (LYMFOR). - PTF301

开始日期2024-05-20

申办/合作机构

PentixaPharm GmbH

100 项与 [68Ga] Pentixafor 相关的临床结果

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100 项与 [68Ga] Pentixafor 相关的转化医学

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100 项与 [68Ga] Pentixafor 相关的专利（医药）

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135

项与 [68Ga] Pentixafor 相关的文献（医药）

2025-05-01·Nuclear Medicine and Biology

Longitudinal multi-tracer imaging of hepatocellular carcinoma identifies novel stage- and oncogene-specific changes

Article

作者: Bankstahl, Jens P ; Bengel, Frank M ; Ott, Michael ; Ross, Tobias L ; Teuter, Mari ; Lolatte, Kelsey ; Balakrishnan, Asha ; Hu, Yuhai

BACKGROUNDHepatocellular carcinoma (HCC) is a leading cause of cancer-related deaths, globally. There is a need for novel biomarkers for early detection and novel, effective targeted therapies. Molecular imaging can faithfully visualize, characterize and quantify specific relevant biological processes.BASIC PROCEDUREWe performed longitudinal dedicated small-animal positron emission tomography-computed tomography (PET/CT) imaging to analyze changes in glucose metabolism using [¹⁸F]fluorodeoxyglucose ([¹⁸F]FDG), amino acid turnover with [¹⁸F]fluoroethyltyrosine ([¹⁸F]FET), and chemokine receptor expression using [⁶⁸Ga]pentixafor targeting CXCR4, during stages of early tumor development, overt HCC and regression. We used two conditional transgenic mouse models of HCC, driven by clinically relevant oncogenes c-MYC (LT2/MYC) or HRASV12 (LT2/RAS). Conditional doxycycline-regulated mouse models, enable liver-specific oncogene activation or inhibition, leading to liver tumor development and regression, respectively. Correlation of our PET/CT findings with our gene expression and metabolomics data and with histological analyses followed.MAIN FINDINGSWe show PET/CT identifies HCC stage-specific and oncogene-specific molecular changes that may serve as potential novel biomarkers and therapeutic targets. Glucose metabolism and CXCR4 chemokine expression are differentially deregulated during HCC development in an oncogene-specific manner. Our [¹⁸F]FDG results correlated with glucose transporter GLUT1 gene expression and with our metabolomics data. Increased expression of CXCR4 and CD68 inflammatory markers mirrored [⁶⁸Ga]pentixafor results in LT2/MYC mice. FET-based measurement of amino acid turnover are insensitive to stages of HCC-development, in our studies. Concurrently, no significant changes in expression of tyrosine metabolism genes were observed.PRINCIPAL CONCLUSIONSOur study highlights that identified changes in targeted molecular imaging can facilitate a better understanding of underlying biological processes and may help guide novel oncogene-specific targeted anti-tumor therapies in HCC, with promising translational potential.

2025-04-01·Academic Radiology

A Prospective Evaluation of Chemokine Receptor-4 (CXCR4) Overexpression in High-grade Glioma Using 68Ga-Pentixafor (Pars-Cixafor™) PET/CT Imaging

Article

作者: Haidar, Mohamad ; Usmani, Sharjeel ; Jafari, Esmail ; Marafi, Fahad ; Al-Ibraheem, Akram ; Esmail, Abdulredha A ; Ricci, Maria ; Dadgar, Habibollah ; Cimini, Andrea ; Al-Balooshi, Batool ; Assadi, Majid ; Arabi, Hossein ; Norouzbeigi, Nasim ; Zaidi, Habib ; Omar, Yehia ; Al-Alawi, Haider Muhsin

BACKGROUNDWhile magnetic resonance imaging (MRI) remains the gold standard for morphological imaging, its ability to differentiate between tumor tissue and treatment-induced changes on the cellular level is insufficient. Notably, glioma cells, particularly glioblastoma multiforme (GBM), demonstrate overexpression of chemokine receptor-4 (CXCR4). This study aims to evaluate the feasibility of non-invasive ⁶⁸Ga-Cixafor™ PET/CT as a tool to improve diagnostic accuracy in patients with high-grade glioma.METHODSIn this retrospective analysis, a database of histopathology-confirmed glioma patients with MRI findings consistent with high-grade gliomas was utilized. Within 2 weeks of their MRI, these patients underwent ⁶⁸Ga-Cixafor™ PET/CT scans to assess CXCR4 expression. Both visual scoring based on established criteria and semi-quantitative measures including maximum standardized uptake value (SUV_max) and tumor-to-background ratios (TBR) were calculated to analyze the PET/CT data.RESULTSOur retrospective study enrolled 29 histologically confirmed glioma patients with MRI findings consistent with high-grade gliomas. All patients underwent ⁶⁸Ga-Cixafor™ PET/CT scans within 2 weeks of their MRI, specifically at one-hour post-injection time point. Visual assessment based on a standardized scoring system identified 27 positive scans out of 29 (93.1%). Median SUV_max was 2.31 (range: 0.49-9.96) and median TBR was 20 (range: 6.12-124.5). Pathological analysis revealed 5 grade III (17.24%) and 24 grade IV (82.75%) lesions among the 29 patients. Notably, the median SUV_max of grade IV lesions (2.85) was significantly higher than grade III lesions (1.27) (P=0.02). Conversely, there was no significant difference in median TBR between grade IV (20) and grade III (22.37). These findings support the correlation between high CXCR4 expression, particularly in high-grade gliomas, and elevated uptake of ⁶⁸Ga-Pentixafor. While areas with high uptake showed CXCR4 expression, areas with low uptake did not exhibit noticeable expression (data not shown).CONCLUSIONThis study demonstrated that ⁶⁸Ga-Cixafor™ PET exhibits a TBR with minimal cortical uptake, significantly enhancing glioma detection compared to conventional imaging methods. This, combined with the potential therapeutic capabilities of CXCR4-targeting radiopharmaceuticals, highlights the promise of ⁶⁸Ga-Cixafor™ as a valuable tool for not only improved glioma diagnosis but also personalized treatment strategies.

2025-01-01·Theranostics

C-X-C motif chemokine receptor 4-directed PET signal in the arterial tree is not consistently linked to calcified plaque burden and cardiovascular risk

Article

作者: Werner, Rudolf A ; Reiter, Theresa ; Hasenauer, Natalie ; Higuchi, Takahiro ; Dreher, Niklas ; Weich, Alexander ; Fröhlich, Matthias ; Michalski, Kerstin ; Hartrampf, Philipp E ; Serfling, Sebastian E ; Kosmala, Aleksander ; Buck, Andreas K

Purpose: To establish the extent, distribution and frequency of in-vivo vessel wall [⁶⁸Ga]Ga-PentixaFor uptake and to determine its relationship with calcified atherosclerotic plaque burden (CAP) and cardiovascular risk factors (CVRF). Methods: 65 oncological patients undergoing [⁶⁸Ga]Ga-PentixaFor PET/CT were assessed. Radiotracer uptake (target-to-background ratio [TBR]) and CAP burden (including number of CAP sites, calcification circumference and thickness) in seven major vessel segments per patient were determined. We then investigated associations of vessel wall uptake with CAP burden, cardiovascular risk (CVRF and European Society of Cardiology [ESC] SCORE2/SCORE2-OP risk chart) and image noise (determined by coefficient of variation [CoV] from unaffected liver parenchyma). Results: We identified 1292 sites of high focal [⁶⁸Ga]Ga-PentixaFor uptake (PentixaFor+ sites) in the vessel wall in 65/65 (100%) patients, with concomitant calcification in 385/1292 (29.8%) sites. There were no significant associations between vessel wall uptake and CAP burden (number of PentixaFor+ sites: r ≤ 0.18, P ≥ 0.14; PentixaFor+ TBR: r ≤ 0.08, P ≥ 0.54). The number of PentixaFor+ sites showed a moderate correlation with cardiovascular risk (ESC SCORE2/SCORE2-OP, r = 0.30; number of CVRF, r = 0.26; P = 0.04, respectively), but failed to reach significance for PentixaFor+ TBR (r ≤ 0.18, P ≥ 0.22). In univariable regression analysis, body mass index (odds ratio [OR] 1.08, 95%-confidence interval [CI] 1.02-1.14) and CoV (OR, 1.07; CI, 1.05-1.10) were linked to TBR and the number of PentixaFor+ sites (P < 0.01, respectively), while injected activity was only associated with the latter imaging parameter (OR, 0.99; CI, 0.98-1.00; P = 0.04). In multivariable regression, injected activity (OR, 1.00; CI, 0.99-1.00) and CoV (OR, 1.06; CI, 1.06-1.07) remained significantly associated with the number of PentixaFor+ sites (P < 0.01, respectively). CoV, however, was the only parameter significantly linked to PentixaFor+ TBR on multivariable analysis (OR, 1.02; CI, 1.01-1.03; P < 0.01). Conclusion: On a visual and quantitative level, high focal [⁶⁸Ga]Ga-PentixaFor uptake in the arterial tree was not consistently linked to vessel wall calcification or cardiovascular risk. Image noise, however, may account for a substantial portion of apparent vessel wall uptake.

100 项与 [68Ga] Pentixafor 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
边缘区B细胞淋巴瘤	临床3期	德国	PentixaPharm GmbH	2024-05-20
边缘区B细胞淋巴瘤	临床3期	法国	PentixaPharm GmbH	2024-05-20
边缘区B细胞淋巴瘤	临床3期	意大利	PentixaPharm GmbH	2024-05-20
边缘区B细胞淋巴瘤	临床3期	奥地利	PentixaPharm GmbH	2024-05-20
边缘区B细胞淋巴瘤	临床3期	西班牙	PentixaPharm GmbH	2024-05-20
醛固酮增多症	临床3期	-	PentixaPharm GmbH	-
肌层浸润性膀胱癌	临床2期	-	PentixaPharm GmbH	-
原发性中枢神经系统淋巴瘤	临床1期	法国	PentixaPharm GmbH	2022-10-05
原发性中枢神经系统淋巴瘤	临床1期	丹麦	PentixaPharm GmbH	2022-10-05
继发性中枢神经系统淋巴瘤	临床1期	丹麦	PentixaPharm GmbH	2022-10-05

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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	醛固酮增多症	-	68Ga-Pentixafor (Single PET model)	(鏇糧選艱網襯餘糧製網) = 繭淵糧範齋膚繭窪網獵夢選獵窪壓襯簾鹽獵製 (鑰糧鏇鹽顧醖壓糧觸繭 )	积极	2024-09-27
ENDO2024	N/A	肾上腺皮质腺瘤	30	[68Ga]Ga-Pentixafor68Ga-Pentixaforafor (68Ga-Pentixafor PET/CT)	鏇膚壓糧構夢範積醖膚(齋憲齋膚蓋窪窪鏇齋積) = 憲衊壓鏇獵醖獵積鹽壓製夢艱獵鹽襯積願網獵 (蓋鏇範鏇鑰廠網壓鬱鑰 ) 更多	-	2024-06-01
ENDO2024	N/A	肾上腺皮质腺瘤	30	[68Ga]Ga-Pentixafor (Adrenal vein sampling (AVS))	鏇膚壓糧構夢範積醖膚(齋憲齋膚蓋窪窪鏇齋積) = 齋簾獵繭築餘餘衊糧艱製夢艱獵鹽襯積願網獵 (蓋鏇範鏇鑰廠網壓鬱鑰 ) 更多	-	2024-06-01
Pubmed \| J Clin Endocrinol Metab	N/A	醛固酮增多症	-	68Ga-Pentixafor (Aldosterone-producing adenoma (APA))	糧積製蓋糧鏇襯鑰選鹹(築鏇獵憲構鏇艱廠齋願) = 鹹鹽餘艱壓鏇積網憲醖簾糧糧獵糧願遞廠範構 (壓製廠鬱憲餘糧積蓋廠 ) 更多	-	2023-12-21
Pubmed \| J Clin Endocrinol Metab	N/A	醛固酮增多症	-	68Ga-Pentixafor (Idiopathic hyperaldosteronism (IHA))	衊壓積繭餘糧範襯鹹願(製觸鏇壓鹹範製鹹蓋製) = 獵觸願鹽鏇繭製膚醖鬱淵築網簾鑰製願積蓋鏇 (構淵餘選膚構顧膚鏇襯 )	-	2023-12-21
SNMMI2023	N/A	弥漫性大B细胞淋巴瘤	-	68Ga-Pentixafor18F-FDGntixafor (18F-FDG PET/CT)	鏇襯鑰糧憲鑰範糧憲衊(齋窪觸願糧蓋簾衊壓鏇) = 繭範鑰範淵鏇夢淵觸鬱襯鏇艱簾鹽膚製鹹構壓 (齋範衊構積醖膚繭蓋醖 ) 更多	-	2023-08-28
CXCR4-DIRECTED (ESH2023)	临床1期	醛固酮增多症	19	[68GA]GA-PENTIXAFOR (AVS)	蓋蓋顧選鏇艱衊鹹艱積(蓋齋鬱蓋醖襯醖鏇憲網) = 夢願淵選製齋構積衊獵簾製鑰願醖餘艱鏇簾積 (簾選夢積構廠憲網淵顧 )	-	2023-06-01
Pubmed \| Eur Radiol	N/A	醛固酮增多症	-	68Ga-pentixafor (Functional nodules in primary aldosteronism)	(繭憲範艱築壓淵壓襯顧) = 8.95 蓋製餘顧鏇鏇壓窪廠醖 (構壓簾遞網淵淵繭蓋鏇 ) 更多	-	2022-09-07
Pubmed \| Eur Radiol	N/A	醛固酮增多症	-	68Ga-pentixafor (Non-functional adrenal adenoma)	(繭憲範艱築壓淵壓襯顧) = 8.95 蓋製餘顧鏇鏇壓窪廠醖 (構壓簾遞網淵淵繭蓋鏇 ) 更多	-	2022-09-07
SNMMI2022	N/A	多形性胶质母细胞瘤	-	68Ga-Pentixafor68Ga- Pentixafor (68Ga-Pentixafor PET/CT)	(鏇繭淵繭積觸醖鹽觸廠) = 網鹹淵窪簾觸餘鹹觸繭遞選鹽遞蓋襯鹽蓋繭醖 (遞襯選窪獵範膚獵廠範, 12.1 ~ 16.4)	-	2022-08-08
SNMMI2021	N/A	肺癌	-	68Ga-Pentixafor68 Ga-Pentixafor (68Ga-Pentixafor)	積遞願鑰醖衊範獵選衊(範構繭醖壓選願醖鏇範) = 獵蓋築選鹽網網網製壓衊廠壓遞網衊網網顧製 (鏇餘鏇醖鹹窪鏇構觸觸, 0.64)	-	2021-05-18
SNMMI2020	N/A	淋巴瘤	-	68Ga-Pentixafor68 Ga-Pentixafor (68Ga-Pentixafor PET/CT)	製壓蓋範選糧獵簾衊觸(願齋構鹽壓壓積顧鏇醖) = 鬱網夢壓構鹽鏇夢廠願衊艱選網膚選艱襯構夢 (構憲糧鑰獵齋糧顧膚夢 )	-	2020-05-15
SNMMI2020	N/A	淋巴瘤	-	68 Ga-Pentixafor18F-FDGentixafor (18F-FDG PET/CT)	製壓蓋範選糧獵簾衊觸(願齋構鹽壓壓積顧鏇醖) = 獵淵襯餘鹹鏇餘鹽糧壓衊艱選網膚選艱襯構夢 (構憲糧鑰獵齋糧顧膚夢 )	-	2020-05-15
NCT03436342 (Pubmed \| Eur J Nucl Med Mol Imaging)	早期临床1期	多发性骨髓瘤	-	<sup>68</sup>Ga-Pentixafor (<sup>18</sup>F-FDG PET/CT)	廠衊餘鹹鹹餘膚廠願衊(選襯獵鹽餘繭願膚餘衊) = 鏇構網襯網餘夢憲選築蓋鬱膚獵廠選醖鬱鬱窪 (艱獵觸鹽廠鹹觸獵鏇選 )	-	2020-03-01