Evidence map›Paper›PMID 42537885›Full record

Trial reportWorld journal of surgery2026

A Multicenter Non-Inferiority Randomized Controlled Trial of Sentinel Lymph Node Biopsy in Early Breast Cancer: Conventional Dual Tracer Versus Superparamagnetic Iron Oxide.

Chiu Hoi Woon Tiffany, Ray Ka Wai Hung, Kong Wai Chung Angela, Kwok Sin Man, Sheung Robin Lok Man, Violet Yee Kei Tsoi

Abstract readRandomized Controlled TrialMulticenter StudyEquivalence Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in World journal of surgery, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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0cells of the map it votes in
0citing papers in PubMed
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1 · What the graph read from 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.

2 · The registry

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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors.

Chiu Hoi Woon TiffanyDepartment of Surgery, The Chinese University of Hong Kong, Hong Kong, China.ORCID https://orcid.org/0009-0003-5304-4189
Ray Ka Wai HungDepartment of Surgery, The Chinese University of Hong Kong, Hong Kong, China.
Kong Wai Chung AngelaDepartment of Surgery, Princess Margaret Hospital, Hong Kong, China.
Kwok Sin ManDepartment of Surgery, Princess Margaret Hospital, Hong Kong, China.
Sheung Robin Lok ManDepartment of Surgery, Princess Margaret Hospital, Hong Kong, China.
Violet Yee Kei TsoiDepartment of Surgery, The Chinese University of Hong Kong, Hong Kong, China.

Funding

Endomagnetics Ltd.
6 · The paper itself

Abstract

backgroundThe gold standard for detecting sentinel lymph node (SLN) in early breast cancer is combined use of radioisotope and blue dye. A newer agent, superparamagnetic iron oxide (SPIO), was developed to address the challenges faced with the traditional method. This study aims to compare the detection rate of SLN biopsy and show the non-inferiority of SPIO.

methodsFrom March 2021 to April 2024, patients with clinically and radiologically node-negative breast cancer were randomized to receive SPIO-only injection or dual tracer for SLN localization. The primary endpoint was the SLN identification rate in both arms.

results148 patients were in the SPIO group with 153 SLN procedures performed. SLN localization failed in one patient. The identification rate was 99.3% (95% CI: 95.8-99.9). 149 patients were in the dual tracer group with 156 SLN procedures done. The identification rate was 100% (95% CI: 97.0-99.9). The absolute difference was 0.7% (95% CI: -1.2 to 2.7).

conclusionOur results suggest that SPIO, as a single agent, used in SLN biopsy for early breast cancer is non-inferior to the dual tracer method. It can serve as a good alternative to radioactive isotope and blue dye.

trial registrationCUHK CREC Ref No. 2019.677-T (https://www.crec.cuhk.edu.hk/).

Indexed as

Breast NeoplasmsFerric CompoundsMagnetic Iron Oxide NanoparticlesMagnetite NanoparticlesSentinel Lymph Node BiopsyAdultAgedContrast MediaFemaleHumansMiddle AgedSentinel Lymph NodeContrast MediaFerric Compoundsferric oxideMagnetite Nanoparticlesbreast cancerbreast surgerysentinel lymph nodesuperparamagnetic iron oxide

Identifiers

PMID42537885
PMCPMC13576606

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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.