ArticleMolecular imaging and biology2021
Safety and Stability of Antibody-Dye Conjugate in Optical Molecular Imaging.
Article in Molecular imaging and biology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers.
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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.
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Who cites it
13 citing papers in PubMed, 15 citations in OpenAlex.
- Interim Phase II Results Using Panitumumab-IRDye800CW during Transoral Robotic Surgery in Patients with Oropharyngeal Cancer.Clinical cancer research : an official journal of the American Association for Cancer Research · 2024Trial
- 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
- Automated cGMP optical labeling of FDA-approved antibodies for human use.Nature protocols · 2026Review
- Single-cell spatial pharmacobiology identifies conserved stromal barriers to therapeutic antibody delivery in human solid tumors.Nature biotechnology · 2026Article
- Use of Dual-Modality Antibody Imaging for Assessment of Lymph Node Metastases in Head and Neck Cancer.Theranostics · 2026Article
- Photosensitizer-Antibody Conjugates (PhotoBodies): Emerging Frontiers in the Field of Theranostics.Pharmaceutical research · 2026Review
- Delineating precise surgical resection areas: recent advances in NIR-II fluorescence imaging molecular probes.Frontiers in oncology · 2026Review
- Making Fluorescent Nylon, Polypropylene, and Polystyrene Microplastics for In Vivo and In Vitro Imaging.Microplastics (Basel, Switzerland) · 2025Article
- Factors for Differential Outcome Across Cancers in Clinical Molecule-Targeted Fluorescence Imaging.Journal of nuclear medicine : official publication, Society of Nuclear Medicine · 2022Article
- First Clinical Results of Fluorescence Lifetime-enhanced Tumor Imaging Using Receptor-targeted Fluorescent Probes.Clinical cancer research : an official journal of the American Association for Cancer Research · 2022Article
- A narrative review of fluorescence imaging in robotic-assisted surgery.Laparoscopic surgery · 2021Article
- EGFR-targeted intraoperative fluorescence imaging detects high-grade glioma with panitumumab-IRDye800 in a phase 1 clinical trial.Theranostics · 2021Article
Corrections and comments
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Authors and funding
20 authors at 5 institutions in 1 country.
Funding
Abstract
purposeThe development of molecularly targeted tracers is likely to improve the accuracy of diagnostic, screening, and therapeutic tools. Despite the many therapeutic antibodies that are FDA-approved with known toxicity, only a limited number of antibody-dye conjugates have been introduced to the clinic. Thorough evaluation of the safety, stability, and pharmacokinetics of antibody conjugates in the clinical setting compared with their parental components could accelerate the clinical approval of antibodies as agents for molecular imaging. Here we investigate the safety and stability of a near-infrared fluorescent dye (IRDye800CW) conjugated panitumumab, an approved therapeutic antibody, and report on the product stability, pharmacokinetics, adverse events, and QTc interval changes in patients. PROCEDURES: Panitumumab-IRDye800CW was made under good manufacturing practice (GMP) conditions in a single batch on March 26, 2014, and then evaluated over 4.5 years at 0, 3, and 6 months, and then at 6-month intervals thereafter. We conducted early phase trials in head and neck, lung, pancreas, and brain cancers with panitumumab-IRDye800CW. Eighty-one patients scheduled to undergo standard-of-care surgery were infused with doses between 0.06 to 2.83 mg/kg of antibody. Patient ECGs, blood samples, and adverse events were collected over 30-day post-infusion for analysis.
resultsEighty-one patients underwent infusion of the study drug at a range of doses. Six patients (7.4 %) experienced an adverse event that was considered potentially related to the drug. The most common event was a prolonged QTc interval which occurred in three patients (3.7 %). Panitumumab-IRDye800CW had two OOS results at 42 and 54 months while meeting all other stability testing criteria.
conclusionsPanitumumab-IRDye800CW was safe and stable to administer over a 54-month window with a low rate of adverse events (7.4 %) which is consistent with the rate associated with panitumumab alone. This data supports re-purposing therapeutic antibodies as diagnostic imaging agents with limited preclinical toxicology studies.
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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.