ArticleMolecular imaging and biology2021
A Standardized Framework for Fluorescence-Guided Margin Assessment for Head and Neck Cancer Using a Tumor Acidosis Sensitive Optical Imaging Agent.
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 23 papers, 1 of them a synthesis that pooled it.
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Who cites it
23 citing papers in PubMed, 1 synthesis or guideline pooled it, 31 citations in OpenAlex.
- A systematic methodology review of fluorescence-guided cancer surgery to inform the development of a core master protocol and outcome set.BMC cancer · 2024Pooled it
- EGFR-targeted fluorescence molecular imaging for intraoperative margin assessment in oral cancer patients: a phase II trial.Nature communications · 2023Trial
- High-Throughput Discovery of Near-Infrared Oxazine Probes for Fluorescence-Guided Glioblastoma Surgery.Cancers · 2026Article
- A Molecular Shielding Strategy to Develop Low Protein Binding, Renal Clearable Pan-Cancer Near-Infrared Probes.Advanced functional materials · 2026Article
- Intraoperative Molecular Imaging in Thoracic Oncology: Expanding the Observable Disease Space.Cancers · 2026Review
- Actionable Feedback on Signal-to-Background Ratios During Drop-in Radioguided Surgery.Journal of nuclear medicine : official publication, Society of Nuclear Medicine · 2026Article
- Bridging preclinical and clinical fluorescence-guided surgery with advanced cancer vision goggles.Npj imaging · 2026Article
- Targeting EpCAM expression via near-infrared fluorescent antibodies enables microscopic delineation of primary and recurrent HNSCC.BMC cancer · 2026Article
- Compatibility of fast tissue clearing with targeted fluorescence imaging and pathology analysis using clinical head and neck cancer biopsies.Scientific reports · 2025Article
- Intraoperative fluorescence in solid head and neck cancer: A scoping review.European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery · 2025Article
- Elucidating the effect of tumor and background region-of-interest selection on the performance metrics used to assess fluorescence imaging.Journal of biomedical optics · 2025Article
- The Use of Fluorescent Markers to Detect and Delineate Head and Neck Cancer: A Scoping Review.Clinical otolaryngology : official journal of ENT-UK ; official journal of Netherlands Society for Oto-Rhino-Laryngology & Cervico-Facial Surgery · 2025Article
- AND-gated protease-activated nanosensors for programmable detection of anti-tumour immunity.Nature nanotechnology · 2025Article
- Cutting-edge insights: near-infrared imaging for surgical margin assessment in head and neck tumor resection: a systematic review and meta-analysis.Quantitative imaging in medicine and surgery · 2024Article
- Ex vivo fluorescence-guided resection margin assessment in breast cancer surgery using a topically applied, cathepsin-activatable imaging agent.Pharmacological research · 2024Article
- Illuminating the future of precision cancer surgery with fluorescence imaging and artificial intelligence convergence.NPJ precision oncology · 2024Review
- Functionalized Polymeric Micelles for Targeted Cancer Therapy: Steps from Conceptualization to Clinical Trials.Pharmaceutics · 2024Review
- Feasibility of a Novel 3D Ultrasound Imaging Technique for Intraoperative Margin Assessment during Tongue Cancer Surgery.Current oncology (Toronto, Ont.) · 2024Article
- First-in-man study of the PSMA Minibody IR800-IAB2M for molecularly targeted intraoperative fluorescence guidance during radical prostatectomy.European journal of nuclear medicine and molecular imaging · 2024Article
- Prostate Specific Membrane Antigen Expression in a Syngeneic Breast Cancer Mouse Model.Molecular imaging and biology · 2024Article
Corrections and comments
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Authors and funding
12 authors at 3 institutions in 2 countries.
Funding
Abstract
purposeIntra-operative management of the surgical margin in patients diagnosed with head and neck squamous cell carcinoma (HNSCC) remains challenging as surgeons still have to rely on visual and tactile information. Fluorescence-guided surgery using tumor-specific imaging agents can assist in clinical decision-making. However, a standardized imaging methodology is lacking. In this study, we determined whether a standardized, specimen-driven, fluorescence imaging framework using ONM-100 could assist in clinical decision-making during surgery. PROCEDURES: Thirteen patients with histologically proven HNSCC were included in this clinical study and received ONM-100 24 ± 8 h before surgery. Fluorescence images of the excised surgical specimen and of the surgical cavity were analyzed. A fluorescent lesion with a tumor-to-background ratio (TBR) > 1.5 was considered fluorescence-positive and correlated to standard of care (SOC) histopathology.
resultsAll six tumor-positive surgical margins were detected immediately after excision using fluorescence-guided intra-operative imaging. Postoperative analysis showed a median TBR (±IQR) of the fluorescent lesions on the resection margin of 3.36 ± 1.62. Three fluorescence-positive lesions in the surgical cavity were biopsied and showed occult carcinoma and severe dysplasia, and a false-positive fluorescence lesion.
conclusionOur specimen-driven fluorescence framework using a novel, pH-activatable, fluorescent imaging agent could assist in reliable and real-time adequate clinical decision-making showing that a fluorescent lesion on the surgical specimen with a TBR of 1.5 is correlated to a tumor-positive resection margin. The binary mechanism of ONM-100 allows for a sharp tumor delineation in all patients, giving the surgeon a clinical tool for real-time margin assessment, with a high sensitivity.
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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.