Trial reportAnnals of surgical oncology2013
Comparative evaluation of [(99m)tc]tilmanocept for sentinel lymph node mapping in breast cancer patients: results of two phase 3 trials.
Trial report in Annals of surgical oncology, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 37 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 Phase 3, Prospective, Open-Label, Multicenter Comparison Study of Lymphoseek® and Vital Blue Dye as Lymphoid Tissue Targeting Agents in Patients With Known Melanoma or Breast Cancer Who Are Undergoing Lymph Node Mapping
A Phase 3, Prospective, Open-Label, Multicenter Comparison Study of Lymphoseek® and Vital Blue Dye as Lymphoid Tissue Targeting Agents in Patients With Known Melanoma or Breast Cancer Who Are Undergoing Lymph Node Mapping
Pilot Study to Test the Feasibility of IV Injected Tc-99m-tilmanocept for Imaging of M2-like Tumour Associated Macrophages in Metastatic Melanoma
Who cites it
37 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Bimodal nanobody agents for cancer imaging and potential intraoperative guidance: a systematic review.Journal of nanobiotechnology · 2026Pooled it
- Pooled it
- A comparative study of mitoxantrone hydrochloride injection and technetium-99 m for tracing axillary sentinel nodes in patients with breast cancer.BMC cancer · 2025Trial
- Comparison of Post-injection Site Pain Between Technetium Sulfur Colloid and Technetium Tilmanocept in Breast Cancer Patients Undergoing Sentinel Lymph Node Biopsy.Annals of surgical oncology · 2015Trial
- Multimodal tilmanocept for preoperative imaging and fluorescence-guided surgery of porcine lateral pelvic sentinel lymph nodes.Scientific reports · 2025Article
- Therapeutic applications of carbohydrate-based compounds: a sweet solution for medical advancement.Molecular diversity · 2024Review
- Fluorescent Guided Sentinel Lymph Mapping of the Oral Cavity with Fluorescent-Labeled Tilmanocept.The Laryngoscope · 2024Article
- Aluminum Fluoride-18 Labeled Mannosylated Dextran: Radiosynthesis and Initial Preclinical Positron Emission Tomography Studies.Molecular imaging and biology · 2023Article
- A pilot study of lymphoscintigraphy with tracer injection into the human brain.Journal of cerebral blood flow and metabolism : official journal of the International Society of Cerebral Blood Flow and Metabolism · 2023Article
- Role of Nuclear Sentinel Lymph Node Mapping Compared to New Alternative Imaging Methods.Journal of personalized medicine · 2023Review
- Article
- 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
- Carbohydrate-based drugs launched during 2000Acta pharmaceutica Sinica. B · 2022Review
- Detection of melanoma, breast cancer and head and neck squamous cell cancer sentinel lymph nodes by Tc-99m Tilmanocept (Lymphoseek®).Clinical & experimental metastasis · 2022Review
- The efficacy ofAnnals of translational medicine · 2022Article
- Repurposing Molecular Imaging and Sensing for Cancer Image-Guided Surgery.Journal of nuclear medicine : official publication, Society of Nuclear Medicine · 2020Review
- Current and novel mapping substances in gynecologic cancer care.International journal of gynecological cancer : official journal of the International Gynecological Cancer Society · 2020Review
- The Basics of Sentinel Lymph Node Biopsy: Anatomical and Pathophysiological Considerations and Clinical Aspects.Journal of oncology · 2019Review
- Outcomes of "one-day" vs "two-day" injection protocols using Tc-99m tilmanocept for sentinel lymph node biopsy in breast cancer.The breast journal · 2018Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
16 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundSentinel lymph node (SLN) surgery is used worldwide for staging breast cancer patients and helps limit axillary lymph node dissection. [(99m)Tc]Tilmanocept is a novel receptor-targeted radiopharmaceutical evaluated in 2 open-label, nonrandomized, within-patient, phase 3 trials designed to assess the lymphatic mapping performance.
methodsA total of 13 centers contributed 148 patients with breast cancer. Each patient received [(99m)Tc]tilmanocept and vital blue dye (VBD). Lymph nodes identified intraoperatively as radioactive and/or blue stained were excised and histologically examined. The primary endpoint, concordance (lower boundary set point at 90 %), was the proportion of nodes detected by VBD and [(99m)Tc]tilmanocept.
resultsA total of 13 centers contributed 148 patients who were injected with both agents. Intraoperatively, 207 of 209 nodes detected by VBD were also detected by [(99m)Tc]tilmanocept for a concordance rate of 99.04 % (p < 0.0001). [(99m)Tc]tilmanocept detected a total of 320 nodes, of which 207 (64.7 %) were detected by VBD. [(99m)Tc]Tilmanocept detected at least 1 SLN in more patients (146) than did VBD (131, p < 0.0001). In 129 of 131 patients with ≥1 blue node, all blue nodes were radioactive. Of 33 pathology-positive nodes (18.2 % patient pathology rate), [(99m)Tc]tilmanocept detected 31 of 33, whereas VBD detected only 25 of 33 (p = 0.0312). No pathology-positive SLNs were detected exclusively by VBD. No serious adverse events were attributed to [(99m)Tc]tilmanocept.
conclusion[(99m)Tc]Tilmanocept demonstrated success in detecting a SLN while meeting the primary endpoint. Interestingly, [(99m)Tc]tilmanocept was additionally noted to identify more SLNs in more patients. This localization represented a higher number of metastatic breast cancer lymph nodes than that of VBD.
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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.