Trial reportThe Journal of thoracic and cardiovascular surgery2023
Pafolacianine for intraoperative molecular imaging of cancer in the lung: The ELUCIDATE trial.
Trial report in The Journal of thoracic and cardiovascular surgery, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 4 registered trials, which are not on this map. Cited by 37 papers, 1 of them a synthesis that pooled it.
What it found
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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.
A Pilot Study of Near-Infrared Imaging Using the Novel Imaging Agent Cytalux for Adolescent Patients With Metastatic Osteosarcoma Undergoing Pulmonary Metastasectomy
Prospective, Multi Center, Open Label Non Inferiority Trial Evaluating the Clinical Adequacy of Intraoperative Tumor Fluorescence With Cytalux™ (Pafolacianine) Across Two Preoperative Administration Windows in Adults Undergoing Surgery for Suspected Lung Cancer or Confirmed Ovarian Cancer
A Single-arm, Open-label, Single-center Clinical Study to Evaluate CDH3-targeted Positron Emission Tomography (PET) for Lung Malignant Tumors
Visualization Study on Tumor Progression Mechanisms and Key Molecular Functions in Neoadjuvant Immunotherapy for Lung Cancer: Preoperative Efficacy Prediction and Intraoperative Fluorescence Navigation
Who cites it
37 citing papers in PubMed, 1 synthesis or guideline pooled it, 48 citations in OpenAlex.
- A Concept for Preoperative and Intraoperative Molecular Imaging and Detection for Assessing Extent of Disease of Solid Tumors.Oncology reviews · 2024Pooled it
- Intraoperative Molecular Imaging With Pafolacianine in Resection of Occult Pulmonary Malignancy in the ELUCIDATE Trial.The Annals of thoracic surgery · 2025Trial
- 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
- Imaging the hallmarks of cancer.Nature reviews. Cancer · 2026Review
- Intraoperative Molecular Imaging in Thoracic Oncology: Expanding the Observable Disease Space.Cancers · 2026Review
- FDA-Approved Drugs Containing Amide Functionality in the Last Five Years (2021-2025): Pharmaceutical Use, Trends and Synthetic Approaches.Medicines (Basel, Switzerland) · 2026Review
- Intraoperative Nodule Localization in Non-Small-Cell Lung Cancer: Existing and Emerging Techniques.Cancers · 2026Review
- Precision at the Margin: Innovations and Challenges in Intraoperative Molecular Imaging for Thoracic Surgery.Journal of clinical medicine · 2026Review
- Translation of Intraoperative Molecular Imaging for Clinical Use.Journal of nuclear medicine : official publication, Society of Nuclear Medicine · 2026Review
- Translational development of an SGLT2-targeted near-infrared contrast agent for intraoperative imaging of early-stage lung cancer.EJNMMI research · 2026Article
- Label-free streamlined photoacoustic image guidance facilitates NIR-II photoablation in models of melanoma lung metastases.The Journal of clinical investigation · 2026Article
- Lighting the path: a narrative review of non-molecular intraoperative lung imaging modalities.Journal of thoracic disease · 2026Review
- Advanced imaging techniques for tumor intraoperative navigation imaging.Npj imaging · 2026Review
- E-Cadherin Is an Accurate Target for Fluorescence-Guided Imaging of Lymph Nodes.Current issues in molecular biology · 2026Article
- Targeting Folate Receptors for the Detection and Selective Treatment of Cancer: Advanced Precision Oncology in Practice.International journal of biological sciences · 2026Review
- Fluorescence-Guided Surgery in Pediatric Oncology: Current Practice and Future Directions.Cancers · 2025Review
- Surgical impact of pafolacianine-based intraoperative molecular imaging in lobar versus sublobar pulmonary resection.JTCVS techniques · 2025Article
- Epithelial Cell Adhesion Molecule Is an Accurate Target for Fluorescence Guided Imaging of Lymph Nodes.Molecular imaging and biology · 2025Article
- Impact of perioperative platelet counts and IL-6 on wound healing outcomes after thoracoscopic lung cancer surgery.Annals of medicine · 2025Article
- Toward fluorescence digital twins: multi-parameter experimental validation of fluorescence Monte Carlo simulations using solid phantoms.Journal of biomedical optics · 2025Article
Corrections and comments
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Authors and funding
7 authors at 5 institutions in 1 country.
Funding
Abstract
objectiveThe study objective was to determine the clinical utility of pafolacianine, a folate receptor-targeted fluorescent agent, in revealing by intraoperative molecular imaging folate receptor α positive cancers in the lung and narrow surgical margins that may otherwise be undetected with conventional visualization.
methodsIn this Phase 3, 12-center trial, 112 patients with suspected or biopsy-confirmed cancer in the lung scheduled for sublobar pulmonary resection were administered intravenous pafolacianine within 24 hours before surgery. Participants were randomly assigned to surgery with or without intraoperative molecular imaging (10:1 ratio). The primary end point was the proportion of participants with a clinically significant event, reflecting a meaningful change in the surgical operation.
resultsNo drug-related serious adverse events occurred. One or more clinically significant event occurred in 53% of evaluated participants compared with a prespecified limit of 10% (P < .0001). In 38 participants, at least 1 event was a margin 10 mm or less from the resected primary nodule (38%, 95% confidence interval, 28.5-48.3), 32 being confirmed by histopathology. In 19 subjects (19%, 95% confidence interval, 11.8-28.1), intraoperative molecular imaging located the primary nodule that the surgeon could not locate with white light and palpation. Intraoperative molecular imaging revealed 10 occult synchronous malignant lesions in 8 subjects (8%, 95% confidence interval, 3.5-15.2) undetected using white light. Most (73%) intraoperative molecular imaging-discovered synchronous malignant lesions were outside the planned resection field. A change in the overall scope of surgical procedure occurred for 29 of the subjects (22 increase, 7 decrease).
conclusionsIntraoperative molecular imaging with pafolacianine improves surgical outcomes by identifying occult tumors and close surgical margins.
Indexed as
Identifiers
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.