ArticleMolecular imaging and biology2015
IND-directed safety and biodistribution study of intravenously injected cetuximab-IRDye800 in cynomolgus macaques.
Article in Molecular imaging and biology, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 45 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
45 citing papers in PubMed, 62 citations in OpenAlex.
- Fluorescent Molecular Imaging Can Improve Intraoperative Sentinel Margin Detection in Oral Squamous Cell Carcinoma.Journal of nuclear medicine : official publication, Society of Nuclear Medicine · 2022Trial
- Metastatic and sentinel lymph node mapping using intravenously delivered Panitumumab-IRDye800CW.Theranostics · 2021Trial
- First-in-human intraoperative near-infrared fluorescence imaging of glioblastoma using cetuximab-IRDye800.Journal of neuro-oncology · 2018Trial
- First-in-human study of PET and optical dual-modality image-guided surgery in glioblastoma usingTheranostics · 2018Trial
- Effects of an Unlabeled Loading Dose on Tumor-Specific Uptake of a Fluorescently Labeled Antibody for Optical Surgical Navigation.Molecular imaging and biology · 2017Trial
- Characterizing the Utility and Limitations of Repurposing an Open-Field Optical Imaging Device for Fluorescence-Guided Surgery in Head and Neck Cancer Patients.Journal of nuclear medicine : official publication, Society of Nuclear Medicine · 2017Trial
- Automated cGMP optical labeling of FDA-approved antibodies for human use.Nature protocols · 2026Review
- Contrasting temporal dynamics of fluorescence and photoacoustic signals from Cetuximab-IRDye800 conjugate in EGFR-overexpressing tumors.Science advances · 2026Article
- Brightening New Horizons: Luminescent Transition Metal Complexes in Optical Imaging and Theranostic Applications.ACS central science · 2025Review
- Quantitative pharmacokinetic and biodistribution studies for fluorescent imaging agents.Biomedical optics express · 2024Article
- Site-specific albumin tagging with NIR-II fluorogenic dye for high-performance and super-stable bioimaging.Theranostics · 2024Article
- In vivo visualization and molecular targeting of the cardiac conduction system.The Journal of clinical investigation · 2022Article
- Preclinical Evaluation of a Humanized, Near-Infrared Fluorescent Antibody for Fluorescence-Guided Surgery of MUC16-Expressing Pancreatic Cancer.Molecular pharmaceutics · 2022Article
- Towards Photodynamic Image-Guided Surgery of Head and Neck Tumors: Photodynamic Priming Improves Delivery and Diagnostic Accuracy of Cetuximab-IRDye800CW.Frontiers in oncology · 2022Article
- Safety and Stability of Antibody-Dye Conjugate in Optical Molecular Imaging.Molecular imaging and biology · 2021Article
- EGFR-targeted intraoperative fluorescence imaging detects high-grade glioma with panitumumab-IRDye800 in a phase 1 clinical trial.Theranostics · 2021Article
- Off-Peak Near-Infrared-II (NIR-II) Bioimaging of an Immunoconjugate Having Peak Fluorescence Emission in the NIR-I Spectral Region for Improving Tumor Margin Delineation.ACS applied bio materials · 2020Article
- Co-administered antibody improves penetration of antibody-dye conjugate into human cancers with implications for antibody-drug conjugates.Nature communications · 2020Article
- Comparison of Panitumumab-IRDye800CW and 5-Aminolevulinic Acid to Provide Optical Contrast in a Model of Glioblastoma Multiforme.Molecular cancer therapeutics · 2020Article
- Predicting Therapeutic Antibody Delivery into Human Head and Neck Cancers.Clinical cancer research : an official journal of the American Association for Cancer Research · 2020Article
Corrections and comments
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Authors and funding
10 authors at 1 institution in 1 country.
Funding
Abstract
purposeThe use of receptor-targeted antibodies conjugated to fluorophores is actively being explored for real-time imaging of disease states; however, the toxicity of the bioconjugate has not been assessed in non-human primates. PROCEDURES: To this end, the in vivo toxicity and pharmacokinetics of IRDye800 conjugated to cetuximab (cetuximab-IRDye800; 21 mg/kg; equivalent to 250 mg/m(2) human dose) were assessed in male cynomolgus monkeys over 15 days following intravenous injection and compared with an unlabeled cetuximab-dosed control group.
resultsCetuximab-IRDye800 was well tolerated. There were no infusion reactions, adverse clinical signs, mortality, weight loss, or clinical histopathology findings. The plasma half-life for the cetuximab-IRDye800 and cetuximab groups was equivalent (2.5 days). The total recovered cetuximab-IRDye800 in all tissues at study termination was estimated to be 12 % of the total dose. Both cetuximab-IRDye800 and cetuximab groups showed increased QTc after dosing. The QTc for the cetuximab-dosed group returned to baseline by day 15, while the QTc of the cetuximab-IRDye800 remained elevated compared to baseline.
conclusionIRDye800 in low molar ratios does not significantly impact cetuximab half-life or result in organ toxicity. These studies support careful cardiac monitoring (ECG) for human studies using fluorescent dyes.
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What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.