Delving into the Latest Updates on [68Ga] Pentixafor with Synapse

Overview

Basic Info

Drug Type

Peptide Conjugate Radionuclide, Diagnostic radiopharmaceuticals

Synonyms

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

+ [3]

Target

CXCR4

Action

antagonists

Mechanism

CXCR4 antagonists(C-X-C motif chemokine receptor 4 antagonists)

Therapeutic Areas

NeoplasmsImmune System DiseasesEndocrinology and Metabolic Disease+ [5]

Active Indication

Marginal Zone B-Cell LymphomaHyperaldosteronismMuscle Invasive Bladder Carcinoma+ [8]

Inactive Indication

Primary Central Nervous System LymphomaSecondary Central Nervous System Lymphoma

Originator Organization

University of Iowa

Active Organization

PentixaPharm GmbH

The Holden Comprehensive Cancer Center

University of Iowa

Inactive Organization-

License Organization-

Drug Highest PhasePhase 3

First Approval Date-

RegulationOrphan Drug (European Union)

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Structure/Sequence

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Sequence Code 525682907

Source: *****

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.

Start Date23 Sep 2024

Sponsor / Collaborator

National Cancer Institute

NCT06478875

/ Not yet recruitingPhase 2IIT

"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).

Start Date01 Jun 2024

Sponsor / Collaborator

Assistance Publique des Hôpitaux de Paris SA

[+1]

CTIS2022-500918-25-00

/ RecruitingPhase 3

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

Start Date20 May 2024

Sponsor / Collaborator

PentixaPharm GmbH

100 Clinical Results associated with [68Ga] Pentixafor

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100 Translational Medicine associated with [68Ga] Pentixafor

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100 Patents (Medical) associated with [68Ga] Pentixafor

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135

Literatures (Medical) associated with [68Ga] Pentixafor

01 May 2025·Nuclear Medicine and Biology

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

Article

Author: 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.

01 Apr 2025·Academic Radiology

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

Article

Author: 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.

01 Jan 2025·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

Author: 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 Deals associated with [68Ga] Pentixafor

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Marginal Zone B-Cell Lymphoma	Phase 3	Germany	PentixaPharm GmbH	20 May 2024
Marginal Zone B-Cell Lymphoma	Phase 3	France	PentixaPharm GmbH	20 May 2024
Marginal Zone B-Cell Lymphoma	Phase 3	Italy	PentixaPharm GmbH	20 May 2024
Marginal Zone B-Cell Lymphoma	Phase 3	Austria	PentixaPharm GmbH	20 May 2024
Marginal Zone B-Cell Lymphoma	Phase 3	Spain	PentixaPharm GmbH	20 May 2024
Hyperaldosteronism	Phase 3	-	PentixaPharm GmbH	-
Muscle Invasive Bladder Carcinoma	Phase 2	-	PentixaPharm GmbH	-
Primary Central Nervous System Lymphoma	Phase 1	France	PentixaPharm GmbH	05 Oct 2022
Primary Central Nervous System Lymphoma	Phase 1	Denmark	PentixaPharm GmbH	05 Oct 2022
Secondary Central Nervous System Lymphoma	Phase 1	Denmark	PentixaPharm GmbH	05 Oct 2022

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


EANM2024	Not Applicable	Hyperaldosteronism	-	68Ga-Pentixafor (Single PET model)	(nioirrohpw) = qkgyabgffo xiblpihccy (vaqsjgmrnq )	Positive	27 Sep 2024
ENDO2024	Not Applicable	Adrenocortical Adenoma	30	[68Ga]Ga-Pentixafor68Ga-Pentixaforafor (68Ga-Pentixafor PET/CT)	pxczlbpbac(nhdtcvbhyj) = fvvupurbye hyslodxhuz (uqycqyfnjp ) View more	-	01 Jun 2024
ENDO2024	Not Applicable	Adrenocortical Adenoma	30	[68Ga]Ga-Pentixafor (Adrenal vein sampling (AVS))	pxczlbpbac(nhdtcvbhyj) = jfmldicggw hyslodxhuz (uqycqyfnjp ) View more	-	01 Jun 2024
Pubmed \| J Clin Endocrinol Metab	Not Applicable	Hyperaldosteronism	-	68Ga-Pentixafor (Aldosterone-producing adenoma (APA))	ffocybawxh(qpthgohvti) = ddcnuzyxmd djemrtorpz (jagqfdooqb ) View more	-	21 Dec 2023
Pubmed \| J Clin Endocrinol Metab	Not Applicable	Hyperaldosteronism	-	68Ga-Pentixafor (Idiopathic hyperaldosteronism (IHA))	sbqnehpsnr(levskovvzf) = gaylwcghyz vzqoswakon (saysokxiof )	-	21 Dec 2023
SNMMI2023	Not Applicable	Diffuse Large B-Cell Lymphoma	-	68Ga-Pentixafor18F-FDGntixafor (18F-FDG PET/CT)	jdofhiahxe(nlltmbmtuh) = rloswogzod gbdfodtils (ebkgxnyioa ) View more	-	28 Aug 2023
CXCR4-DIRECTED (ESH2023)	Phase 1	Hyperaldosteronism	19	[68GA]GA-PENTIXAFOR (AVS)	yopccpwigq(gsvhjeypsp) = ufxysnsxid jkkbccvbwu (bquytxufom )	-	01 Jun 2023
Pubmed \| Eur Radiol	Not Applicable	Hyperaldosteronism	-	68Ga-pentixafor (Functional nodules in primary aldosteronism)	(uomqxtooyh) = 8.95 bvpjoqnqwv (oreifsqoua ) View more	-	07 Sep 2022
Pubmed \| Eur Radiol	Not Applicable	Hyperaldosteronism	-	68Ga-pentixafor (Non-functional adrenal adenoma)	(uomqxtooyh) = 8.95 bvpjoqnqwv (oreifsqoua ) View more	-	07 Sep 2022
SNMMI2022	Not Applicable	Glioblastoma Multiforme	-	68Ga-Pentixafor68Ga- Pentixafor (68Ga-Pentixafor PET/CT)	(rbaperbpne) = lvdwsrhrsd kwthrcxzeh (hhnmcrymia, 12.1 - 16.4)	-	08 Aug 2022
SNMMI2021	Not Applicable	Lung Cancer	-	68Ga-Pentixafor68 Ga-Pentixafor (68Ga-Pentixafor)	wffktvgqrx(ubloymeaih) = kqqqlojsdb stxlnkhumk (otjuqmyoep, 0.64)	-	18 May 2021
SNMMI2020	Not Applicable	Lymphoma	-	68Ga-Pentixafor68 Ga-Pentixafor (68Ga-Pentixafor PET/CT)	hrfeureneu(xdnqvhdfll) = zcdjlxkorr scjvihydks (djksfrbsdo )	-	15 May 2020
SNMMI2020	Not Applicable	Lymphoma	-	68 Ga-Pentixafor18F-FDGentixafor (18F-FDG PET/CT)	hrfeureneu(xdnqvhdfll) = mtckuguheh scjvihydks (djksfrbsdo )	-	15 May 2020
NCT03436342 (Pubmed \| Eur J Nucl Med Mol Imaging)	Early Phase 1	Multiple Myeloma	-	<sup>68</sup>Ga-Pentixafor (<sup>18</sup>F-FDG PET/CT)	wjaysddulq(hsdandpwrs) = nzsrwyrzpm gsxylndqui (gffpnpvwuv )	-	01 Mar 2020

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