Cetuximab-IRDye800CW (University Medical Center Groningen)(Cetuximab-IRDye800CW (University Medical Center Groningen)) - 药物靶点：EGFR_在研适应症：头颈部鳞状细胞癌，胶质母细胞瘤，高级别胶质瘤_专利_临床

概要

基本信息

药物类型

抗体光敏剂缀合物

别名-

靶点

EGFR

作用方式

拮抗剂

作用机制

EGFR拮抗剂(表皮生长因子受体erbB1拮抗剂)

治疗领域

肿瘤神经系统疾病泌尿生殖系统疾病+ [1]

在研适应症

头颈部鳞状细胞癌胶质母细胞瘤高级别胶质瘤+ [1]

非在研适应症

乳腺癌局部晚期直肠癌直肠腺癌

原研机构

Universitair Medisch Centrum Groningen

在研机构

Universitair Medisch Centrum Groningen

非在研机构-

权益机构-

最高研发阶段临床2期

首次获批日期-

最高研发阶段(中国)-

特殊审评-

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结构/序列

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Sequence Code 43254L

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Sequence Code 9505399H

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关联

11

项与 Cetuximab-IRDye800CW (University Medical Center Groningen) 相关的临床试验

NCT05929456

/ Recruiting临床1期

Multispectral and Bimodal Fluorescent Guided Surgery (FGS) of High-grade Glioma for Refining Margin Assessment: A Phase 1 Dose Finding Study Using Cetuximab-IRDye800CW Combined With 5-ALA.

The MIRROR study is a prospective, single center phase I feasibility and dose finding study in patients with high-grade glioma, to establish the safety, feasibility, and optimal dosage of Cetuximab-IRDye800CW for fluorescence guided surgery, in comparison to the standard of care (SOC), 5-ALA fluorescent imaging agent. The main research objectives of this study are:
1. To determine the optimal dosage of Cetuximab-IRDye800CW for fluorescence guided surgery
2. To assess the safety and tolerability
3. To correlate fluorescent signals measured by in vivo multispectral imaging with Cetuximab-IRDye800CW and 5-ALA with those measured by ex vivo imaging
The study population will consist of patients, aged ≥18 years, diagnosed with high-grade glioma and scheduled for surgery.

开始日期2023-05-05

申办/合作机构

Universitair Medisch Centrum Groningen

NCT05499065

/ Completed临床2期

Real-time Margin Assessment in Head and Neck Cancer - Enhancing Specificity by Combining Fresh Frozen Sectioning With Targeted Fluorescence Imaging

To investigate if the combination of fresh frozen sectioning based on cetuximab-800CW can enhance tumor-positive margin detection intra-operatively.

开始日期2023-03-01

申办/合作机构

Universitair Medisch Centrum Groningen

NCT05376202

/ Completed临床1期

Fluorescent Guided Surgery in Penile Carcinoma Using Cetuximab-800IRDyeCW

The main treatment modality for Penile Squamous Cell Carcinoma (PSCC) is surgery with curative intent. In organ sparing surgery a tumor-positive margin of up to 36% exist. Tumor-positive surgical margins are an independent risk factor for local recurrence, which has been reported to be up to 18%. Tumor-positive margins always lead to extra, penile sparing surgery, which leads to longer hospitalization, higher exposure to anesthetic interventions and a worse psychological outcome.
Currently, no intraoperative imaging technique that provides real time feedback for resection margins exists in PSCC. Molecular fluorescence-guided Surgery (MFGS) using targeted near-infrared (NIR) optical contrast agents like for example Cetuximab-800CW is a promising technique to accommodate this need. Epidermal Growth Factor Receptor (EGFR) is overexpressed in PSCC and has safely and successfully been used as target for molecular imaging, particularly for assessment for tumor margins in head and neck squamous cell carcinoma (ICON study, UMCG1).

开始日期2022-03-07

申办/合作机构

Universitair Medisch Centrum Groningen

[+1]

100 项与 Cetuximab-IRDye800CW (University Medical Center Groningen) 相关的临床结果

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100 项与 Cetuximab-IRDye800CW (University Medical Center Groningen) 相关的转化医学

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100 项与 Cetuximab-IRDye800CW (University Medical Center Groningen) 相关的专利（医药）

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9

项与 Cetuximab-IRDye800CW (University Medical Center Groningen) 相关的文献（医药）

2025-12-03·JOURNAL OF BIOMEDICAL OPTICS

Epidermal growth factor receptor-targeted near-infrared probe cetuximab-IRDye800CW enables stable and tumor-specific fluorescence imaging in colorectal cancer models

Article

作者: Jiang, Yongjun ; Huang, Yong ; Wang, Daorong ; Zhang, Xianhu

Significance:

Colorectal cancer (CRC) remains a major cause of cancer-related mortality, with incomplete resection contributing to recurrence and poor survival. Improving intraoperative margin detection is critical to enhance surgical precision and patient outcomes.

Aim:

We aim to evaluate the tumor-targeting specificity of cetuximab-IRDye800CW (Cet-IRDye800CW), an epidermal growth factor receptor (EGFR)-specific near-infrared probe, for fluorescence-guided surgery in CRC models.

Approach:

Cet-IRDye800CW and IgG-IRDye800CW controls were synthesized and tested in LS174T and SW948 xenografts as well as patient-derived xenografts (PDXs). Mice received __-mml:math xmlns:mml="http://www.w3.org/1998/Math/MathML"-__200 μ g of the probe intravenously and underwent daily fluorescence imaging for 10 days. Tumor-to-background ratio (TBR) and mean fluorescence intensity (MFI) were quantified, and EGFR expression was analyzed by Western blot, reverse transcription quantitative polymerase chain reaction, and immunohistochemistry.

Results:

Cetuximab-IRDye800CW significantly enhanced tumor fluorescence compared with controls in all models ( __-mml:math xmlns:mml="http://www.w3.org/1998/Math/MathML"-__p < 0.05 ). TBR increased progressively and peaked on day 10 (LS174T: __-mml:math xmlns:mml="http://www.w3.org/1998/Math/MathML"-__25.6 ± 2.94 ; SW948: __-mml:math xmlns:mml="http://www.w3.org/1998/Math/MathML"-__21.6 ± 1.71 ), whereas background MFI declined, resulting in improved tumor contrast. Tumor-specific fluorescence was detectable from day 1 and intensified over time. Similar findings were observed in PDX models, consistent with high EGFR expression.

Conclusion:

Cetuximab-IRDye800CW provides stable, tumor-specific, high-contrast fluorescence imaging in EGFR-high CRC models. These findings validate its molecular targeting capability and support its translational potential for fluorescence-guided CRC surgery.

2025-08-01·European Journal of Nuclear Medicine and Molecular Imaging

Vancomycin-based tracers guiding in situ visualization of bacteria on osteosynthesis devices and surgical debridement

Article

作者: Kruijff, Schelto ; Keizers, Bas ; IJpma, Frank F A ; Feringa, Ben L ; van Dijl, Jan Maarten ; Spoelstra, Gerbren B ; Elsinga, Philip H ; Szymanski, Wiktor ; Glaudemans, Andor W J M ; van Snick, Johannes H ; van Oosten, Marleen

Abstract:

Purpose:

Bacterial infections associated with musculoskeletal injuries are challenging to detect and distinguish from sterile inflammation. Here we present the combined first-time application of a bacteria-targeted positron emission tomography (PET) tracer and a near-infrared fluorescent tracer to detect infected osteosynthesis implants and guide surgical treatment.

Methods:

To this end, osteosynthesis plates covered with bacterial biofilm and pre-incubated with [18F]PQ-VE1-vancomycin for PET imaging and/or vancomycin-IRDye800CW for optical imaging were fixed to post-mortem human tibiae and femora. PET/CT and fluorescence imaging were used to quantify the bacterial load before and after surgical debridement.

Results:

Pre-debridement, PET imaging showed a significant 2.2-fold higher tracer uptake on biofilm-covered plates compared to plates without biofilm (p < 0.001). Post-debridement, the PET signal was marginal, demonstrating effective biofilm removal. Fluorescence-guided surgery enabled real-time visualization and removal of bacterial biofilms.

Conclusion:

Combined preoperative PET and intraoperative fluorescence imaging with vancomycin-based tracers allows noninvasive detection and real-time infection management, as demonstrated by these preliminary findings.

2022-12-01·Photodiagnosis and photodynamic therapy

NIR-II nano fluorescence image guided hepatic carcinoma resection on cirrhotic patient

作者: Zhang, Yang ; Li, Bo ; Su, Song ; Zhang, Zeyu ; Hu, Zhenhua ; Fang, Cheng ; Liu, Gang ; Tian, Jie

Precise resection of hepatic carcinoma (HCC) remains challenging for cirrhotic patients. Cirrhosis not only effects intraoperative palpation, but can also cause severe false-positive problems to indocyanine green (ICG) fluorescence imaging. Herein, we report the application of a nano-scale probe IgG-IRDye800CW to achieve precise HCC resection from cirrhotic liver. A 66-year-old male patient with liver cancer received intravenous injection of IgG-IRDye800CW (10 mg) 6 days prior to surgery, and none adverse effects were observed. During the operation, the HCC lesion in the right liver lobe was specifically detected on the near-infrared window II (NIR-II) fluorescence images. The high-contrast NIR-II fluorescence delineated a clear margin to improve surgical precision. These clinical observations showed high safety and feasibility of applying IgG-IRDye800CW NIR-II fluorescence imaging to guide hepatic surgery and minimize hepatic function damage.

100 项与 Cetuximab-IRDye800CW (University Medical Center Groningen) 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
头颈部鳞状细胞癌	临床2期	荷兰	Universitair Medisch Centrum Groningen	2023-03-01
胶质母细胞瘤	临床1期	荷兰	Universitair Medisch Centrum Groningen	2023-05-05
高级别胶质瘤	临床1期	荷兰	Universitair Medisch Centrum Groningen	2023-05-05
阴茎肿瘤	临床1期	荷兰	Universitair Medisch Centrum Groningen	2022-03-07
局部晚期直肠癌	临床1期	荷兰	Universitair Medisch Centrum Groningen	2020-11-13
直肠腺癌	临床1期	荷兰	Universitair Medisch Centrum Groningen	2013-10-01
乳腺癌	临床1期	荷兰	Universitair Medisch Centrum Groningen	2011-10-01

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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


NCT02736578 (CTgov)	临床2期	胰腺腺癌	8	Cetuximab-IRDye800+Cetuximab (Cetuximab IRDye800, 50 mg)	鹽積獵憲製衊顧鹽衊積(網襯艱遞遞遞壓願顧衊) = 顧簾憲鹽遞繭鏇積廠廠壓鏇窪齋醖衊襯襯構獵 (選簾憲製醖艱餘壓遞選, 0.72) 更多	-	2019-02-01
				Cetuximab-IRDye800+Cetuximab (Cetuximab IRDye800, 100 mg)	觸憲鹽鬱選觸鹽鹹窪淵(夢積鬱壓鑰範願範衊鏇) = 顧衊簾鬱憲鏇糧遞餘壓齋膚範壓遞膚鏇蓋衊遞 (夢積獵鹽鑰糧蓋繭糧窪, 0.02) 更多
NCT04161560 (Pubmed \| J Neurooncol)	临床1期	胶质母细胞瘤	3	Cetuximab-IRDye800 50mg	蓋艱顧淵積糧願願範艱(鹹獵窪顧鹽廠醖鏇廠膚) = 衊衊願鹽鏇鹽窪遞壓選壓願醖築選積壓壓餘積 (構膚鑰窪鏇鹽鑰壓築繭 ) 更多	-	2018-08-01
				Cetuximab-IRDye800 100mg	蓋艱顧淵積糧願願範艱(鹹獵窪顧鹽廠醖鏇廠膚) = 衊糧餘鹹築壓齋遞鏇糧壓願醖築選積壓壓餘積 (構膚鑰窪鏇鹽鑰壓築繭 ) 更多
NCT02855086 (CTgov)	临床1/2期	胶质瘤	3	IRDye 800+Cetuximab (Cohort 1 (Cetuximab, Lower Dose Cetuximab-IRDye 800, Surgery))	範夢網襯餘積選醖願繭(膚膚鬱窪襯壓膚鬱憲網) = 鹹觸遞憲齋網淵積衊築顧築遞範膚淵膚範襯築 (鬱衊築遞範襯壓壓繭構, 鬱製簾遞壓獵夢窪築選 ~ 齋築網鏇願範鏇鑰獵膚) 更多	-	2018-05-14
				IRDye 800+Cetuximab (Cohort 2 (Cetuximab, Higher Dose Cetuximab-IRDye 800, Surgery))	範夢網襯餘積選醖願繭(膚膚鬱窪襯壓膚鬱憲網) = 願繭憲糧醖蓋鹹齋積網顧築遞範膚淵膚範襯築 (鬱衊築遞範襯壓壓繭構, 淵鑰鑰築蓋繭遞鑰選壓 ~ 簾顧鑰憲願壓鹹齋夢壓) 更多