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

Overview

Basic Info

Drug Type

Small molecule drug, Diagnostic radiopharmaceuticals

Synonyms

FMISO

+ [1]

Target-

Action-

Mechanism-

Therapeutic Areas

NeoplasmsDigestive System DisordersNervous System Diseases+ [1]

Active Indication

Hepatocellular CarcinomaHigh grade gliomaHypoxia

Inactive Indication-

Originator Organization

Advanced Imaging Projects LLC

Active Organization

Weill Medical College of Cornell UniversityAdvanced Imaging Projects LLC

The University of Texas at Austin

Inactive Organization-

License Organization-

Drug Highest PhasePhase 2

First Approval Date-

Regulation-

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Structure/Sequence

Molecular FormulaC6H8FN3O3

InChIKeyHIIJZYSUEJYLMX-JZRMKITLSA-N

CAS Registry104613-87-8

The purpose of the study is to see if using an investigational drug called [18F]FMISO with PET/MRI imaging can help monitor and predict the effect of trastuzumab (Herceptin) on chemotherapy in patients diagnosed with advanced HER2 positive breast cancer. This study is for imaging purposes only and is not a treatment study. The results of this study will not change a patient's clinical treatment plan but it may help physicians and researchers better understand how best to treat patients with breast cancer in the future.

Start Date01 Apr 2025

Sponsor / Collaborator

The University of Alabama at Birmingham

NCT05996432

/ RecruitingEarly Phase 1IIT

Non-invasive, Image-Based, In-Vivo Assessment of Tumor Hypoxia to Guide Hypoxia-Driven Adaptive Radiation Therapy

This study will apply novel MRI approaches with established sensitivity to tissue oxygen consumption and perfusion to predict hypoxia-associated radiation resistance, manifested as tumor recurrence and progression post-treatment.

Start Date17 May 2023

Sponsor / Collaborator

The Vanderbilt-Ingram Cancer Center

[+1]

100 Clinical Results associated with 18F-Fluoromisonidazole

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100 Translational Medicine associated with 18F-Fluoromisonidazole

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100 Patents (Medical) associated with 18F-Fluoromisonidazole

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361

Literatures (Medical) associated with 18F-Fluoromisonidazole

01 Nov 2024·Journal of Radioanalytical and Nuclear Chemistry

Evaluation of an automated synthesis method for [18F]Fluoromisonidazole using a Scintomics GRP® module

Author: Rubow, Sietske ; Oliver, Jayed ; Le Roux, Jannie

AbstractThere is limited information on utilizing commercially supplied [18F]Fluoride from an off-site cyclotron for the synthesis of radiopharmaceuticals. This study explored the production of the PET hypoxia marker [18F]FMISO, using the Scintomics® GRP module and distantly produced [18F]Fluoride, which lacks published data. A radiochemical yield of 27.4 ± 3.6% (n = 5) and high radiochemical purity were achieved in synthesis time of 48 min. The [18F]FMISO met all Ph. Eur. standards, demonstrating the consistency and reliability of the module in generating a clinical-grade radiopharmaceutical using off-site produced [18F]Fluoride, but available patient doses were severely limited.

01 Nov 2024·Biomedical Physics & Engineering Express

Mathematical modeling of ¹⁸F-Fluoromisonidazole (¹⁸F-FMISO) radiopharmaceutical transport in vascularized solid tumors

Article

Author: Rahmim, Arman ; Abazari, Mohammad Amin ; Eydi, Faezeh ; Kashkooli, Farshad Moradi ; Soltani, M

Abstract18F-Fluoromisonidazole (18F-FMISO) is a highly promising positron emission tomography radiopharmaceutical for identifying hypoxic regions in solid tumors. This research employs spatiotemporal multi-scale mathematical modeling to explore how different levels of angiogenesis influence the transport of radiopharmaceuticals within tumors. In this study, two tumor geometries with heterogeneous and uniform distributions of capillary networks were employed to incorporate varying degrees of microvascular density. The synthetic image of the heterogeneous and vascularized tumor was generated by simulating the angiogenesis process. The proposed multi-scale spatiotemporal model accounts for intricate physiological and biochemical factors within the tumor microenvironment, such as the transvascular transport of the radiopharmaceutical agent, its movement into the interstitial space by diffusion and convection mechanisms, and ultimately its uptake by tumor cells. Results showed that both quantitative and semi-quantitative metrics of 18F-FMISO uptake differ spatially and temporally at different stages during tumor growth. The presence of a high microvascular density in uniformly vascularized tumor increases cellular uptake, as it allows for more efficient release and rapid distribution of radiopharmaceutical molecules. This results in enhanced uptake compared to the heterogeneous vascularized tumor. In both heterogeneous and uniform distribution of microvessels in tumors, the diffusion transport mechanism has a more pronounced than convection. The findings of this study shed light on the transport phenomena behind 18F-FMISO radiopharmaceutical distribution and its delivery in the tumor microenvironment, aiding oncologists in their routine decision-making processes.

01 Oct 2024·Journal of Nuclear Medicine

Development of¹⁸F-Fluoromisonidazole Hypoxia PET/CT Diagnostic Interpretation Criteria and Validation of Interreader Reliability, Reproducibility, and Performance

Article

Author: Michaud, Laure ; Schöder, Heiko ; Wray, Rick ; Yeh, Randy ; Leithner, Doris ; Humm, John ; Wong, Richard ; Riaz, Nadeem ; Mirtcheva, Rosna ; Mauguen, Audrey ; Sherman, Eric ; Lee, Nancy

Tumor hypoxia, an integral biomarker to guide radiotherapy, can be imaged with ¹⁸F-fluoromisonidazole (¹⁸F-FMISO) hypoxia PET. One major obstacle to its broader application is the lack of standardized interpretation criteria. We sought to develop and validate practical interpretation criteria and a dedicated training protocol for nuclear medicine physicians to interpret ¹⁸F-FMISO hypoxia PET. Methods: We randomly selected 123 patients with human papillomavirus-positive oropharyngeal cancer enrolled in a phase II trial who underwent 123 ¹⁸F-FDG PET/CT and 134 ¹⁸F-FMISO PET/CT scans. Four independent nuclear medicine physicians with no ¹⁸F-FMISO experience read the scans. Interpretation by a fifth nuclear medicine physician with over 2 decades of ¹⁸F-FMISO experience was the reference standard. Performance was evaluated after initial instruction and subsequent dedicated training. Scans were considered positive for hypoxia by visual assessment if ¹⁸F-FMISO uptake was greater than floor-of-mouth uptake. Additionally, SUV_max was determined to evaluate whether quantitative assessment using tumor-to-background ratios could be helpful to define hypoxia positivity. Results: Visual assessment produced a mean sensitivity and specificity of 77.3% and 80.9%, with fair interreader agreement (κ = 0.34), after initial instruction. After dedicated training, mean sensitivity and specificity improved to 97.6% and 86.9%, with almost perfect agreement (κ = 0.86). Quantitative assessment with an estimated best SUV_max ratio threshold of more than 1.2 to define hypoxia positivity produced a mean sensitivity and specificity of 56.8% and 95.9%, respectively, with substantial interreader agreement (κ = 0.66), after initial instruction. After dedicated training, mean sensitivity improved to 89.6% whereas mean specificity remained high at 95.3%, with near-perfect interreader agreement (κ = 0.86). Conclusion: Nuclear medicine physicians without ¹⁸F-FMISO hypoxia PET reading experience demonstrate much improved interreader agreement with dedicated training using specific interpretation criteria.

100 Deals associated with 18F-Fluoromisonidazole

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External Link

KEGG	Wiki	ATC	Drug Bank
-	18F-Fluoromisonidazole	-	DB14830

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Hepatocellular Carcinoma	Phase 2	-	The University of Texas at Austin	-
Hepatocellular Carcinoma	Phase 2	-	Advanced Imaging Projects LLC	-
High grade glioma	Phase 1	United States	Weill Medical College of Cornell University	01 Feb 2021
Hypoxia	Phase 1	United States	Weill Medical College of Cornell University	01 Feb 2021

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02016872 (CTgov)	Not Applicable	Hypoxia \| Non-Small Cell Lung Cancer	25	PET/CT+18F-FMISO	pmotohcpuv(jcgtdzsfax) = vxvtncemhb dulixbuezv (rwqkiwrlew, tesjuuvjdy - bbocpvissy) View more	-	30 Apr 2025
ASTRO2024	Not Applicable	Squamous Cell Carcinoma of Head and Neck	-	18F-Fluoromisonidazole (FMISO PET positive for tumor hypoxia)	(hpgoffysnq) = ehwmicgzpq dxahqdvjyr (xqzymtwlkf ) View more	-	01 Oct 2024
ASTRO2024	Not Applicable	Squamous Cell Carcinoma of Head and Neck	-	18F-Fluoromisonidazole (FMISO PET negative for tumor hypoxia)	-	-	01 Oct 2024
NCT03303469 (CTgov)	Phase 2	Hepatocellular Carcinoma	3	FMISO	wcuxvmiqcq(dejmgysryp) = sqcflhidxv uqlhlecwxo (mvrvtmlsjw, skgvtaclma - rritfyftdi) View more	-	21 Feb 2021
EANM2019	Not Applicable	Lung Cancer CD34 \| GLUT-1 \| CAIX ... View more	20	[18F]-FMISO	hjjikinxcc(stcdptxehn) = ppyioohkeo etbqtduaud (mwqxtuxfka, 25.8)	Positive	18 Sep 2019
EANM2019	Not Applicable	Lung Cancer CD34 \| GLUT-1 \| CAIX ... View more	20	[18F]-FMISO ([18F]-FAZA)	hjjikinxcc(stcdptxehn) = ffbybtwlzk etbqtduaud (mwqxtuxfka, 13.76)	Positive	18 Sep 2019
SNMMI2019	Not Applicable	Cardiac sarcoidosis	-	FMISOFDGSO (FDG PET)	qmbtnkudkl(zusilcnebw) = coalopaubk pnkuxnprkl (amesvyqeqe, 1.71)	-	21 May 2019
NCT02471313 (CTgov)	Phase 2	Hepatocellular Carcinoma	3	[18F] FMISO	pitwiajybb(grmyawyjah) = bysekpwsmh wkqyhutrjx (ddtqsohtdi, jwnlqzajyw - uhqswoibac) View more	-	23 Apr 2019
ASTRO2015	Not Applicable	Non-small cell lung cancer stage I	-	18F-fluoromisonidazole (FMISO-PET/CT before SBRT)	ljxgiijpgq(zyccxcbley) = vajqrdcvue thrnyacojr (rmmzopgnjj )	-	01 Nov 2015
ASTRO2015	Not Applicable	Non-small cell lung cancer stage I	-	18F-fluoromisonidazole (FMISO-PET/CT after SBRT)	ljxgiijpgq(zyccxcbley) = efjxeastnr thrnyacojr (rmmzopgnjj )	-	01 Nov 2015
SNMMI2015	Not Applicable	Non-Small Cell Lung Cancer	-	18F-FMISOO (18F-FMISO PET/CT scan)	frupmgbnsb(igqygujrjl) = wismniltyl mracdnqmzx (bgbgycpcow, 1.0)	-	15 May 2015
SNMMI2015	Not Applicable	Non-Small Cell Lung Cancer	-	18 FMISO (NSCLC patients)	lkbgnyqicf(uiyonzsjku) = dzsnbkrapu xipfimofff (eyxtulurma, 0.092 - 0.33) View more	-	15 May 2015
ASTRO2014	Not Applicable	Chordoma	-	18F-FMISO (Proton or combined proton/photon RT)	lqmmvxogyc(skvtjfvwjg) = wdfsyecunt bxujlidezu (dzeqxcbngi )	-	01 Sep 2014