Trial reportJAMA otolaryngology-- head & neck surgery2013
Use of a novel receptor-targeted (CD206) radiotracer, 99mTc-tilmanocept, and SPECT/CT for sentinel lymph node detection in oral cavity squamous cell carcinoma: initial institutional report in an ongoing phase 3 study.
Trial report in JAMA otolaryngology-- head & neck surgery, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00911326 (A Ph 3, Prospective, Open-Label, Multicenter Study of Lymphoseek®-Identified Sentinel Lymph Nodes), which is not on this map. Cited by 28 papers, 2 of them syntheses that pooled it.
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.
A Ph 3, Prospective, Open-Label, Multicenter Study of Lymphoseek®-Identified Sentinel Lymph Nodes (SLNs) Relative to the Path Status of Non SLN in an Elective Neck Dissection in Cutaneous Head and Neck and Intraoral Squamous Cell Carcinoma
Who cites it
28 citing papers in PubMed, 2 syntheses or guidelines pooled it, 71 citations in OpenAlex.
- Pooled it
- Diagnostic Efficacy of Sentinel Lymph Node Biopsy in Early Oral Squamous Cell Carcinoma: A Meta-Analysis of 66 Studies.PloS one · 2017Pooled it
- Nuclear Medicine Tracers Targeting Tumor-Associated Macrophages.Pharmaceutics · 2026Review
- Glucan-Based Nanoparticles Empower Precision Cancer Immunotherapy: Design Strategies, Immune Reprogramming Mechanisms, and Clinical Translation Prospects.International journal of nanomedicine · 2026Review
- Micrometastasis and Isolated Tumor Cells in Oral Squamous Cell Carcinoma: Refining Nodal Staging with Emerging Technologies.Head and neck pathology · 2025Review
- Fluorescent Guided Sentinel Lymph Mapping of the Oral Cavity with Fluorescent-Labeled Tilmanocept.The Laryngoscope · 2024Article
- Cost-Effectiveness of [Annals of surgical oncology · 2023Article
- Role of sentinel lymph node biopsy for oral squamous cell carcinoma: Current evidence and future challenges.Head & neck · 2023Review
- Technetium Tc 99m tilmanocept fails to detect sentinel lymph nodes in endometrial cancer.Gynecologic oncology reports · 2022Article
- Sentinel Lymph Node Biopsy in Early Stages of Oral Squamous Cell Carcinoma Using the Receptor-Targeted RadiotracerDiagnostics (Basel, Switzerland) · 2021Article
- Beyond Vessel Diameters: Non-invasive Monitoring of Flow Patterns and Immune Cell Recruitment in Murine Abdominal Aortic Disorders by Multiparametric MRI.Frontiers in cardiovascular medicine · 2021Article
- Technetium-Radiolabeled Mannose-Functionalized Gold Nanoparticles as Nanoprobes for Sentinel Lymph Node Detection.Molecules (Basel, Switzerland) · 2020Article
- The yin and yang of imaging tumor associated macrophages with PET and MRI.Theranostics · 2019Review
- Molecular Weight-Dependent Activity of Aminated Poly(α)glutamates as siRNA Nanocarriers.Polymers · 2018Article
- Article
- Targeting mannose receptor expression on macrophages in atherosclerotic plaques of apolipoprotein E-knockout mice usingEJNMMI research · 2017Article
- Targeting CpG Adjuvant to Lymph Node via Dextran Conjugate Enhances Antitumor Immunotherapy.Bioconjugate chemistry · 2017Article
- Contemporary use of sentinel lymph node biopsy in the head and neck.World journal of otorhinolaryngology - head and neck surgery · 2016Article
- The inextricable axis of targeted diagnostic imaging and therapy: An immunological natural history approach.Nuclear medicine and biology · 2016Review
- Sentinel lymph node biopsy in oral and oropharyngeal squamous cell carcinoma: current status and unresolved challenges.European journal of nuclear medicine and molecular imaging · 2015Review
Corrections and comments
- Commented on by
Authors and funding
6 authors at 1 institution in 1 country.
Funding
Abstract
importanceSentinel lymph node biopsy has been proposed as an alternative to up-front elective neck dissection (END) for determination of pathologic nodal status in patients undergoing surgical treatment for oral cavity squamous cell carcinoma (OSCC) with clinically negative neck (cN0). Sentinel lymph node biopsy using current standard tracer agents and imaging adjuncts such as radiolabeled sulfur-colloid and planar lymphoscintigraphy (LS), however, is associated with several drawbacks.
objectiveTo assess the preliminary utility of technetium Tc 99m (99mTc)-tilmanocept, a novel molecular imaging agent for sentinel lymph node (SLN) mapping, in OSCC. DESIGN, SETTING, AND
participantsProspective, nonrandomized, single-arm, part of an ongoing phase 3 clinical trial. Patients had previously untreated, clinically and radiographically node-negative OSCC (T1-4aN0M0) at an academic tertiary referral center.
interventionsPatients received a single dose of 50 µg 99mTc-tilmanocept injected peritumorally followed by dynamic planar LS and fused single-photon emission computed tomography/computed tomography (SPECT/CT) prior to surgery. Surgical intervention consisted of excision of the primary tumor and radioguided SLN dissection followed by planned END. The excised lymph nodes (SLNs and non-SLNs) underwent histopathologic evaluation for presence of metastatic disease. MAIN OUTCOMES AND MEASURES: False-negative rate and negative predictive value of SLNB using 99mTc-tilmanocept and comparison of planar LS with SPECT/CT in SLN localization.
resultsTwelve of 20 patients (60%) had metastatic neck disease on pathologic examination. All 12 had at least 1 SLN positive for metastases. No patients had a positive END node who did not have at least 1 positive SLN. These data yield a false-negative rate of 0% and negative predictive value of 100% using 99mTc-tilmanocept in this setting. Dynamic planar LS and SPECT/CT revealed a mean (range) number of hot spots per patient of 2.9 (1-7) and 3.7 (1-12), respectively. Compared with planar LS, SPECT/CT identified additional putative SLNs in 11 of 20 cases (55%). CONCLUSIONS AND RELEVANCE: The high negative predictive value and low false-negative rate in identification of occult metastases shows 99mTc-tilmanocept to be a promising agent in SLN identification in patients with OSCC. Use of SPECT/CT improves preoperative SLN localization including delineation of SLN locations near the primary tumor when compared with planar LS imaging.
trial registrationclinicaltrials.gov Identifier: NCT00911326.
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.