Delving into the Latest Updates on 18F-Florbenguane with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

[18F]meta-fluorobenzylguanidine, Florbenguane (18F), Florbenguane F18(USAN)

+ [1]

Target-

Action-

Mechanism-

Therapeutic Areas

NeoplasmsOther DiseasesNervous System Diseases+ [4]

Active Indication

NeuroblastomaLewy Body DiseaseParkinson Disease+ [6]

Inactive Indication

Neural Crest TumorPheochromocytoma

Originator Organization

Ground Fluor Pharmaceuticals, Inc.

Active Organization

Illumina Radiopharmaceuticals LLC

Ground Fluor Pharmaceuticals, Inc.

Inactive Organization-

License Organization-

Drug Highest PhasePhase 3

First Approval Date-

RegulationOrphan Drug (United States)

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Structure/Sequence

Molecular FormulaC8H10FN3

InChIKeyHNPHEZIYSZIWHH-RVRFMXCPSA-N

CAS Registry156021-12-4

This is a Phase 2 study evaluating the positron-emitting radiopharmaceutical 18F-mFBG as an imaging agent for quantification of the effect of neurodegenerative diseases on myocardial sympathetic innervation. Effectiveness of 18F-mFBG imaging of the heart will be judged in terms of the quantitative difference between results for subjects with Lewy body and non-Lewy body neurologic disease as compared to historical data for healthy control subjects.

Start Date30 Oct 2025

Sponsor / Collaborator

Illumina Radiopharmaceuticals LLC

NCT06965621

/ Not yet recruitingPhase 2

An Open-Label, Exploratory, Phase 2 Scintigraphy Study Evaluating 18F mFBG for Imaging Myocardial Sympathetic Innervation in Subjects With Heart Failure and Implantable Cardioverter-Defibrillators

This is a Phase 2 study evaluating the positron-emitting radiopharmaceutical 18F-mFBG as an imaging agent for quantification of myocardial sympathetic innervation. The study will examine a group of stable patients with heart failure (HF) from ischemic cardiomyopathy. All subjects will have left ventricular ejection fraction (LVEF) ≤35% and implantable cardioverter-defibrillators (ICD). The primary objectives of the study will be to:
* document the degree to which 18F-mFBG uptake in the heart is reduced (compared to historical controls)
* characterize the distribution of regional abnormalities in relation to findings on rest/stress positron-emission tomography (PET) myocardial perfusion imaging (MPI)
* determine if there are global and/or regional differences in myocardial sympathetic innervation between subjects who have and have not experienced an appropriate ICD activation within the previous 12 months Effectiveness of 18F-mFBG will be judged in relation to historical experience with other nuclear imaging agents for cardiac sympathetic innervation imaging such as a 123I-meta-iodobenzylguanidine (mIBG) and 11C-hydroxyephedrine (HED).
Safety data will be collected to identify adverse events [AEs] and serious adverse events [SAEs] and characterize the safety profile of 18F-mFBG.

Start Date30 Sep 2025

Sponsor / Collaborator

Illumina Radiopharmaceuticals LLC

[+1]

NCT06852807

/ RecruitingNot ApplicableIIT

Prospective Clinical Study of 18F-mFBG PET Imaging in Neuroblastoma

The aim of this study is to evaluate the diagnostic performance and tumor burden of 18F-metafluorobenzylguanidine (18F-MFBG) positron emission tomography (PET) in patients with neuroblastoma.

Start Date04 Feb 2025

Sponsor / Collaborator

The First Affiliated Hospital, Zhejiang University Sch of Med

100 Clinical Results associated with 18F-Florbenguane

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100 Translational Medicine associated with 18F-Florbenguane

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100 Patents (Medical) associated with 18F-Florbenguane

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13

Literatures (Medical) associated with 18F-Florbenguane

01 Jun 2025·European Journal of Nuclear Medicine and Molecular Imaging

Leveraging small voxel with optimal acquisition time for [18F]mFBG total-body PET/CT imaging in pediatric patients with neuroblastoma: a preliminary study

Article

Author: Zou, Sijuan ; Liu, Aiguo ; Tang, Hongmei ; Song, Shuang ; Zhu, Xiaohua ; Cheng, Zhaoting ; Wu, Yang ; Zhu, Yuankai ; Deng, Xiaoyun

PURPOSE:

The advent of total-body PET/CT presents an opportunity for significant advancements in imaging of neuroblastoma with [¹⁸F]meta-fluorobenzylguanidine ([¹⁸F]mFBG). Small voxel imaging has proven to have better lesion detectability but need enough radioactivity counts. This study aims to balance shortened acquisition times and small voxel reconstruction to keep sufficient image quality and diagnostic confidence on [¹⁸F]mFBG total-body PET for neuroblastoma.

METHODS:

We retrospectively enrolled 33 pediatric patients with neuroblastoma who underwent 37 [¹⁸F]mFBG total-body uEXPLORER PET/CT scans of 10-min duration. PET images were reconstructed with varying acquisition times (0.5-10 min) and three matrix sizes (192 × 192, 512 × 512 and 1024 × 1024). The subjective (scored on a 5-point scale) and objective image quality (signal-to-noise ratio, SNR) of all the sets of reconstructed images were analyzed by nuclear medicine physicians. For indeterminate lesions identified in the group of 192 × 192 matrix with the 10-min scan (G192-10), diagnostic confidence was further evaluated in images reconstructed with the 512 × 512 and 1024 × 1024 matrices (G512 and G1024).

RESULTS:

Of the 33 patients with 37 [¹⁸F]mFBG PET/CT scans, 17 patients with 20 scans had positive [¹⁸F]mFBG PET/CT findings. Sufficient subjective image quality was achieved with at least 2-min acquisition of 192 × 192 matrix and 4-min acquisition of 512 × 512 matrix (with all scores ≥ 3). SNR increased with longer acquisition times for the same voxel size, while decreased as voxel size shrunk. Although the Curie and SIOPEN scores remained consistent across G192, G512, and G1024-10 groups, the G512 groups with at least 2-min acquisition and G1024-10 showed significantly higher confidence scores for characterizing indeterminate lesions on the G192-10 images, with almost all indeterminate lesions being rated as very confident.

CONCLUSIONS:

A matrix of 512 × 512 with a minimum of 4-min acquisition on [¹⁸F]mFBG total-body PET/CT is recommended for sufficient image quality and improved diagnostic confidence, particularly in detecting indeterminate lesions.

09 Jan 2025·CHEMISTRY-A EUROPEAN JOURNAL

Triflyl [¹⁸F]Fluoride as a Solution for Base‐Sensitive Late‐Stage Nucleophilic Aromatic ¹⁸F‐Fluorination Reactions

Article

Author: Vugts, Danielle J. ; Haveman, Lizeth Y. F. ; van Eeden, Sjoerd P. P. ; Windhorst, Albert D. ; de Kruijff, Anna M. T.

Abstract:

Fluorine‐18 is the predominant radionuclide used to label Positron Emission Tomography (PET) tracers. One outstanding challenge in nucleophilic aromatic radiofluorination reactions is the sensitivity of precursors and catalysts for basic reaction conditions, which are necessary for the work‐up of [18F]fluoride, resulting in limited reproducibility. Triflyl [18F]fluoride is a new [18F]fluoride source that allows freedom in choice of type and amounts of base and cryptand. The aim of the current work is to explore the scope and limitations of triflyl [18F]fluoride in the late‐stage nucleophilic aromatic 18F‐fluorination of various functionalized precursors, exploring reduced amounts of base and cryptand. The assessment allowed for the application of this new nucleophilic [18F]fluoride reagent to the successful radiosynthesis of boron, stannane, hypervalent iodonium ylide and phenol substrates bearing electron‐deficient, ‐neutral and ‐rich functional groups as well as the clinically relevant PET tracers [18F]FPEB, [18F]mFBG and [18F]SynVesT‐1.

01 Mar 2023·European Journal of Nuclear Medicine and Molecular Imaging

[18F]mFBG PET-CT for detection and localisation of neuroblastoma: a prospective pilot study

Article

Author: Samim, Atia ; Braat, Arthur J A T ; Lam, Marnix G E H ; Poot, Alex J ; Windhorst, Albert D ; Tolboom, Nelleke ; Blom, Thomas ; van Noesel, Max M ; Viol, Sebastiaan L Meyer ; de Keizer, Bart ; Fiocco, Marta ; Tytgat, Godelieve A M ; van Rooij, Rob

Abstract :

Purpose:

Meta-[18F]fluorobenzylguanidine ([18F]mFBG) is a positron emission tomography (PET) radiotracer that allows for fast and high-resolution imaging of tumours expressing the norepinephrine transporter. This pilot study investigates the feasibility of [18F]mFBG PET-CT for imaging in neuroblastoma.

Methods:

In a prospective, single-centre study, we recruited children with neuroblastoma, referred for meta-[123I]iodobenzylguanidine ([123I]mIBG) scanning, consisting of total body planar scintigraphy in combination with single-photon emission computed tomography-CT (SPECT-CT). Within two weeks of [123I]mIBG scanning, total body PET-CTs were performed at 1 h and 2 h after injection of [18F]mFBG (2 MBq/kg). Detected tumour localisations on scan pairs were compared. Soft tissue disease was quantified by number of lesions and skeletal disease by SIOPEN score.

Results:

Twenty paired [123I]mIBG and [18F]mFBG scans were performed in 14 patients (median age 4.9 years, n = 13 stage 4 disease and n = 1 stage 4S). [18F]mFBG injection was well tolerated and no related adverse events occurred in any of the patients. Mean scan time for [18F]mFBG PET-CT (9.0 min, SD 1.9) was significantly shorter than for [123I]mIBG scanning (84.5 min, SD 10.5), p < 0.01. Most tumour localisations were detected on the 1 h versus 2 h post-injection [18F]mFBG PET-CT. Compared to [123I]mIBG scanning, [18F]mFBG PET-CT detected a higher, equal, and lower number of soft tissue lesions in 40%, 55%, and 5% of scan pairs, respectively, and a higher, equal, and lower SIOPEN score in 55%, 30%, and 15% of scan pairs, respectively. On average, two more soft tissue lesions and a 6-point higher SIOPEN score were detected per patient on [18F]mFBG PET-CT compared to [123I]mIBG scanning.

Conclusion:

Results of this study demonstrate feasibility of [18F]mFBG PET-CT for neuroblastoma imaging. More neuroblastoma localisations were detected on [18F]mFBG PET-CT compared to [123I]mIBG scanning. [18F]mFBG PET-CT shows promise for future staging and response assessment in neuroblastoma.

Trial registration:

Dutch Trial Register NL8152.

100 Deals associated with 18F-Florbenguane

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Neuroblastoma	Phase 3	United States	Illumina Radiopharmaceuticals LLC	18 Nov 2021
Lewy Body Disease	Phase 2	-	Illumina Radiopharmaceuticals LLC	30 Oct 2025
Parkinson Disease	Phase 2	-	Illumina Radiopharmaceuticals LLC	30 Oct 2025
Heart Failure	Phase 2	United States	Illumina Radiopharmaceuticals LLC	30 Sep 2025
Ischemic cardiomyopathy	Phase 2	United States	Illumina Radiopharmaceuticals LLC	30 Sep 2025
Mucolipidoses	Phase 2	United States	Illumina Radiopharmaceuticals LLC	30 Sep 2025
Neural Crest Tumor	Phase 2	United States	Illumina Radiopharmaceuticals LLC	01 Jan 2025
Pheochromocytoma	Phase 2	United States	Illumina Radiopharmaceuticals LLC	01 Jan 2025
Arrhythmias, Cardiac	Phase 2	United States	Illumina Radiopharmaceuticals LLC	05 Nov 2021
Coronary Artery Disease	Phase 2	United States	Illumina Radiopharmaceuticals LLC	05 Nov 2021

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


SNMMI2023	Not Applicable	Neuroblastoma	-	18F-MFBG (MFBG PET imaging)	fvrkifvpvd(psohmgqchf) = No severe adverse events were noted in patients after MFBG injection jzauyuskeb (ohzdmhxnrd )	-	28 Aug 2023
				18F-MFBG (MIBG imaging)