[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，诊断试剂_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、[68Ga]Ga-PentixaFor

靶点

CXCR4

作用机制

CXCR4拮抗剂(C-X-C基序趋化因子受体4拮抗剂)、PET imaging(正电子发射断层成像术增强剂)

治疗领域

肿瘤免疫系统疾病血液及淋巴系统疾病+ [2]

在研适应症

边缘区B细胞淋巴瘤醛固酮增多症诊断试剂+ [1]

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

University of IowaThe Holden Comprehensive Cancer Center

PentixaPharm GmbH初创企业

非在研机构-

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

使用我们的XDC技术数据为新药研发加速。

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序列信息

Sequence Code 525682907

来源: *****

关联

24

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

NCT06125028 / 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 Exemplary for CXCR4-positive Malignant Lymphomas: a Prospective, International, Multi-center, Comparative, Randomized, Cross-over, Open-label Lymphoma Diagnostic Trial

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

开始日期2024-06-01

申办/合作机构

PentixaPharm GmbH初创企业

[+1]

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]

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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106

项与 [68Ga] Pentixafor 相关的文献（医药）

2024-11-01·European Journal of Radiology

[68 Ga]Ga-CXCR4 PET/CT imaging in high-grade glioma for assessment of CXCR4 receptor expression

Article

作者: Norouzbeigi, Nasim ; Roustaei, Hessamoddin ; Aryana, Kamran ; Askari, Emran ; Beheshti, Mohsen ; Anvari, Kazem ; Aziz Kalantari, Bagher ; Vosoughi, Habibeh

PURPOSEGliomas account for 75 % of primary malignant CNS tumors. High-grade glioma (CNS WHO grades 3 and 4) have an unfavorable treatment response and poor outcome. CXCR4 is a G protein-coupled receptor that plays an important part in the signaling pathway between cancer cells and tumor microenvironment. CXCR4 overexpression has been shown in a variety of cancers. In this study, we evaluate the potential value of [⁶⁸Ga]Ga-Pentixafor as a PET/CT CXCR4-probe for in vivo assessment of CXCR4 expression in patients with high-grade glioma and its correlation with tumor grade.MATERIALS AND METHODS[⁶⁸Ga]Ga-CXCR4 PET/CT was performed in the prospective single-center study in treatment-naïve biopsy-proven patients with high-grade glioma. The acquired images were analyzed qualitatively and semi-quantitatively.RESULTA total of 26 patients (mean age: 53.3±14.4 years, 11 women, 15 men) were enrolled. CNS WHO grade 3 pathology was seen in 19 % (5/26) of the sample. The patient-based sensitivity of ⁶⁸Ga-CXCR4 was 96.2 %. Overall, 28 pathologic lesions were detected, leading to a lesion-based sensitivity of 96.4 %. The median (IQR) SUV_max of grade 4 lesions was substantially greater than the grade 3(3.03(2.5-3.7) vs. 1.51(1.2-1.8), p = 0.0145).). The highest tracer activity of organs -beside bladder as the main excretion reservoir-was in lymphoid tissue of Waldeyer's ring (mean SUV_max: 7.41), and spleen (mean SUV_max: 6.62).CONCLUSIONIn conclusion, this new application for [⁶⁸Ga]Ga-Pentixafor PET tracer exhibits excellent visual and semi-quantitative diagnostic properties. Further studies are warranted.

2024-10-01·European Journal of Nuclear Medicine and Molecular Imaging

Predictive value of C-X-C motif chemokine receptor 4-directed molecular imaging in patients with advanced adrenocortical carcinoma

Article

作者: Hahner, Stefanie ; Buck, Andreas K ; Schloetelburg, Wiebke ; Serfling, Sebastian E ; Dreher, Niklas ; Fassnacht, Martin ; Werner, Rudolf A ; Hartrampf, Philipp E ; Kosmala, Aleksander ; Schirbel, Andreas

AbstractBackgroundIn patients affected with adrenocortical carcinoma (ACC), C-X-C motif chemokine receptor 4 (CXCR4) is highly expressed in sites of disease in an ex-vivo setting. We aimed to determine the predictive value of CXCR4-targeting [68Ga]Ga-PentixaFor PET/CT for outcome when compared to clinical parameters.MethodsWe identified 41 metastasized ACC patients imaged with [68Ga]Ga-PentixaFor PET/CT. Scans were assessed visually and on a quantitative level by manually segmenting the tumor burden (providing tumor volume [TV], peak/mean/maximum standardized uptake values [SUV] and tumor chemokine receptor binding on the cell surface [TRB], defined as SUVmean multiplied by tumor volume). Clinical parameters included sex, previous therapies, age, Weiss-Score, and Ki67 index. Following imaging, overall survival (OS) was recorded.ResultsAfter [68Ga]Ga-PentixaFor PET/CT, median OS was 9 months (range, 1–96 months). On univariable analysis, only higher TRB (per 10 ml, HR 1.004, 95%CI: 1.0001–1.007, P = 0.005) and presence of CXCR4-positive peritoneal metastases (PM) were associated with shorter OS (HR 2.03, 95%CI: 1.03–4.02, P = 0.04). Presence of CXCR4-positive liver metastases (LM) trended towards significance (HR 1.85, 0.9–4.1, P = 0.11), while all other parameters failed to predict survival. On multivariable analysis, only TRB was an independent predictor for OS (HR 1.0, 95%CI: 1.00-1.001, P = 0.02). On Kaplan-Meier analysis, TRB above median (13.3 months vs. below median, 6.4 months) and presence of CXCR4-positive PM (6.4 months, vs. no PM, 11.4 months) were associated with shorter survival (P < 0.05, respectively). Presence of LM, however, was also linked to less favorable outcome (8.5 months vs. no LM, 18.1 months), without reaching significance (P = 0.07).ConclusionsIn advanced ACC, elevated tumor chemokine receptor binding on the tumor cell surface detected through [68Ga]Ga-PentixaFor PET/CT is an independent predictor for OS, while other imaging and clinical parameters failed to provide relevant prognostic information.

2024-09-01·Clinical Oncology

Prospective Phase II Study of Radiotherapy Dose Escalation in Grade 4 Glioma Using 68Ga-Pentixafor PET Scan

Article

作者: Tripathi, M ; Sahoo, S K ; Singla, N ; Kumar, R ; Kumar, N ; Chatterjee, D ; Goyal, S ; Trivedi, G ; Madan, R ; Khosla, D ; Dracham, C B ; Ahuja, C K ; Yadav, A

AIMSLocal failure remains the major concern in grade 4 glioma or glioblastoma (GBM). Pilot studies have shown a radiotherapy (RT) dose-response relationship in GBM. Here we present our preliminary data of RT dose escalation using ⁶⁸Ga-Pentixafor PET scan. High ⁶⁸Ga-pentixafor uptake in glioma cells helps in sharp demarcation between tumour and normal brain.MATERIALS AND METHODSThis phase II prospective study was conducted from 2018 to 2020. Thirty, biopsy-proven cases of grade 4 glioma were included. All patients underwent post-operative MRI of the brain and ⁶⁸Ga-Pentixafor PET scan. RT was planned in 2-phases. Phase-1 GTV (GTV1) comprised of T2/flair abnormality, PET-avid disease and post-op cavity. A margin of 2cm was given to GTV-1 to create phase-1 CTV (CTV1), which was further expanded to 0.5cm to generate phase-1 PTV (PTV1). A radiation dose of 46Gy/23fr was prescribed to PTV-1. Phase-2 GTV (GTV2) consisted of CT/MRI contrast-enhancing lesion, PET avid disease and post-op cavity. A margin of 0.5 cm was given to GTV2 to create phase-2 CTV (CTV2) which was expanded to 0.5 cm to create phase-2 PTV (PTV2). RT dose of 14 Gy/7 fr was prescribed to PTV2. PET avid disease was delineated as GTV PET and a margin of 3mm was given to generate PTV-PET which received escalated RT dose of 21 Gy/7fr by simultaneous integrated boost (SIB) in phase 2 (Total dose to PTV PET = 67 Gy/30 fr). All patients received concurrent and adjuvant temozolomide. The data was prospectively maintained in Microsoft Excel sheet. SPSS v 23 was used for statistical analysis. The primary endpoints were estimation of the overall survival (OS) and progression-free survival (PFS), and secondary endpoint was to measure the incidence of radiation necrosis. Categorical variables were reported as frequency and percentage and quantitative variables were reported as median and range.RESULTSData from thirty patients were analysed. A median OS of 23 months was observed with estimated 1, 2 and 3 years OS of 90%, 40% and 17.8% respectively. A significant association of OS was seen with the extent of surgery (p = 0.04) and kernofsky performance status (p = 0.007). No patient developed significant radiation necrosis.CONCLUSIONSThe index study did not show any survival benefit from dose escalation RT. However, all of the patients tolerated the treatment well and none of them developed radiation necrosis. Considering the small sample size as a limitation of the index study, the role of ⁶⁸Ga-pentixafor PET scan for radiation dose escalation should be further explored.CLINICAL TRIAL NUMBERCTRI/2019/05/019146.

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	西班牙	PentixaPharm GmbH初创企业	2024-06-01
醛固酮增多症	临床2期	法国	PentixaPharm GmbH初创企业	2024-06-01
诊断试剂	临床1期	-	University of Iowa	-
神经内分泌肿瘤	临床1期	-	University of Iowa	-
原发性中枢神经系统淋巴瘤	临床前	丹麦	PentixaPharm GmbH初创企业	2022-10-05
原发性中枢神经系统淋巴瘤	临床前	法国	PentixaPharm GmbH初创企业	2022-10-05
继发性中枢神经系统淋巴瘤	临床前	法国	PentixaPharm GmbH初创企业	2022-10-05
继发性中枢神经系统淋巴瘤	临床前	丹麦	PentixaPharm GmbH初创企业	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


Pubmed \| J Clin Endocrinol Metab	N/A	醛固酮增多症	-	68Ga-Pentixafor (Aldosterone-producing adenoma (APA))	網簾觸醖範壓衊願膚鏇(網繭齋鑰構觸簾淵繭獵) = 糧鏇網顧蓋鏇艱築獵構淵獵築餘襯醖鏇網襯網 (獵選觸鹹願鹽構壓簾齋 ) 更多	-	2023-12-21
				68Ga-Pentixafor (Idiopathic hyperaldosteronism (IHA))	淵鹹鹹廠選夢選觸糧廠(觸鬱顧糧窪構鑰膚艱繭) = 鹹淵顧鬱遞衊製鬱蓋壓襯鹽衊鹽繭糧鑰膚願鑰 (構築齋範積艱獵艱醖簾 )
Pubmed \| Eur Radiol	N/A	醛固酮增多症	-	68Ga-pentixafor (Functional nodules in primary aldosteronism)	(醖糧餘夢齋窪鑰鹹鏇鹹) = 8.95 鑰積窪網衊壓壓範艱選 (齋獵繭構鹽網壓淵襯窪 ) 更多	-	2022-09-07
				68Ga-pentixafor (Non-functional adrenal adenoma)
NCT03436342 (Pubmed)	早期临床1期	多发性骨髓瘤	-	<sup>68</sup>Ga-Pentixafor (<sup>18</sup>F-FDG PET/CT)	鏇淵壓網選範鏇獵壓鑰(餘觸壓廠鑰淵糧顧艱膚) = 糧醖夢簾簾憲獵鬱廠簾糧觸獵簾獵網獵遞醖積 (餘鹽廠網構簾齋觸觸簾 )	-	2020-03-01