Evidence map›Paper›PMID 22752379›Full record

Trial reportAnnals of surgical oncology2012

Randomized comparison of near-infrared fluorescence imaging using indocyanine green and 99(m) technetium with or without patent blue for the sentinel lymph node procedure in breast cancer patients.

Joost R van der Vorst, Boudewijn E Schaafsma, Floris P R Verbeek, Merlijn Hutteman, J Sven D Mieog, Clemens W G M Lowik, Gerrit-Jan Liefers, John V Frangioni, Cornelis J H van de Velde, Alexander L Vahrmeijer

Open access · hybridAbstract readComparative StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Annals of surgical oncology, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 64 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
64citing papers in PubMed, 4 pooled it
5.0field-weighted citation impact, top 4% of its field
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

64 citing papers in PubMed, 4 syntheses or guidelines pooled it, 133 citations in OpenAlex.

  1. Pooled it
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  7. Real-time intraoperative detection of breast cancer using near-infrared fluorescence imaging and Methylene Blue.European journal of surgical oncology : the journal of the European Society of Surgical Oncology and the British Association of Surgical Oncology · 2014
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  15. Observational
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4 more citing papers are in PubMed but not listed here.

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

10 authors at 2 institutions in 2 countries.

Joost R van der VorstDepartment of Surgery, Leiden University Medical Center, Leiden, The Netherlands.
Boudewijn E Schaafsma
Floris P R Verbeek
Merlijn Hutteman
J Sven D Mieog
Clemens W G M Lowik
Gerrit-Jan Liefers
John V Frangioni
Cornelis J H van de Velde
Alexander L Vahrmeijer
Leiden University Medical Center · NLBeth Israel Deaconess Medical Center · US

Funding

Intraoperative Near-Infrared Fluorescence ImagingR01CA115296 · NCI · CURADEL, LLC · PI FRANGIONI, JOHN V · 2005 to 2014
$13.9M
NIR Fluorescent SLN Mapping for Breast CancerR21CA130297 · NCI · BETH ISRAEL DEACONESS MEDICAL CENTER · PI FRANGIONI, JOHN V · 2008 to 2009
$765k
NCI NIH HHS R01 CA115296NCI NIH HHS R01-CA-115296NCI NIH HHS R21 CA130297NCI NIH HHS R21-CA-130297
6 · The paper itself

Abstract

backgroundNear-infrared (NIR) fluorescence imaging using indocyanine green (ICG) has the potential to improve sentinel lymph node (SLN) mapping of breast cancer. We performed a randomized clinical trial to assess the value of blue dyes when used in combination with NIR fluorescence. We also preliminarily examined the possibility of performing SLN mapping without radiotracers.

methodsClinical trial subjects were 24 consecutive breast cancer patients scheduled to undergo SLN biopsy. All patients received standard of care using 99(m) technetium-nanocolloid and received 1.6 mL of 500 μM ICG injected periareolarly. Patients were randomly assigned to undergo SLN biopsy with or without patent blue. To assess the need for radiocolloids to localize the SLN or SLNs, the surgeon did not use the handheld gamma probe during the first 15 min after the axillary skin incision.

resultsSLN mapping was successful in 23 of the 24 patients. No significant difference was found in signal-to-background ratio between the groups with and without patent blue (8.3 ± 3.8 vs. 10.3 ± 5.7, respectively, P = 0.32). In both groups, 100 % of SLNs were radioactive and fluorescent, and in the patent blue group, only 84 % of SLNs were stained blue. In 25 % of patients, the use of the gamma probe was necessary to localize the SLN within the first 15 min.

conclusionsThis study shows that there is no benefit of using patent blue for SLN mapping in breast cancer patients when using NIR fluorescence and 99(m) technetium-nanocolloid. NIR fluorescence imaging outperformed patent blue in all patients.

Indexed as

Indocyanine GreenOrganotechnetium CompoundsRadiopharmaceuticalsRosaniline DyesSentinel Lymph Node BiopsySpectroscopy, Near-InfraredAdultAgedBreast NeoplasmsCarcinoma, Ductal, BreastCarcinoma, LobularColoring AgentsFemaleFluorescenceFollow-Up StudiesHumansColoring AgentsIndocyanine GreenOrganotechnetium CompoundsRadiopharmaceuticalsRosaniline Dyessulfan blue

Identifiers

PMID22752379
PMCPMC3465510
OpenAlexW2017972169

What OpenQuestion holds

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Registered trials

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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.