Evidence map›Paper›PMID 21360075›Full record

Trial reportBreast cancer research and treatment2011

Randomized, double-blind comparison of indocyanine green with or without albumin premixing for near-infrared fluorescence imaging of sentinel lymph nodes in breast cancer patients.

Merlijn Hutteman, J Sven D Mieog, Joost R van der Vorst, Gerrit Jan Liefers, Hein Putter, Clemens W G M Löwik, John V Frangioni, Cornelis J H van de Velde, Alexander L Vahrmeijer

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

Trial report in Breast cancer research and treatment, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 71 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
71citing papers in PubMed, 2 pooled it
6.0field-weighted citation impact, top 3% 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

71 citing papers in PubMed, 2 syntheses or guidelines pooled it, 154 citations in OpenAlex.

  1. Pooled it
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  18. HSA-ZW800-PEG for Enhanced Optophysical Stability and Tumor Targeting.International journal of molecular sciences · 2023
    Article
  19. Observational
  20. Article

11 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

9 authors at 2 institutions in 2 countries.

Merlijn HuttemanDepartment of Surgery, Leiden University Medical Center, Albinusdreef 2, 2300 RC Leiden, The Netherlands.
J Sven D Mieog
Joost R van der Vorst
Gerrit Jan Liefers
Hein Putter
Clemens W G M Löwik
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
NCATS NIH HHS L30 TR002482NCI NIH HHS R01 CA115296NCI NIH HHS R01-CA-115296NCI NIH HHS R21 CA130297NCI NIH HHS R21-CA-130297
6 · The paper itself

Abstract

Near-infrared (NIR) fluorescence imaging has the potential to improve sentinel lymph node (SLN) mapping in breast cancer. Indocyanine green (ICG) is currently the only clinically available fluorophore that can be used for SLN mapping. Preclinically, ICG adsorbed to human serum albumin (ICG:HSA) improves its performance as a lymphatic tracer in some anatomical sites. The benefit of ICG:HSA for SLN mapping of breast cancer has not yet been assessed in a clinical trial. We performed a double-blind, randomized study to determine if ICG:HSA has advantages over ICG alone. The primary endpoint was the fluorescence brightness, defined as the signal-to-background ratio (SBR), of identified SLNs. Clinical trial subjects were 18 consecutive breast cancer patients scheduled to undergo SLN biopsy. All patients received standard of care using (99m)Technetium-nanocolloid and patent blue. Patients were randomly assigned to receive 1.6 ml of 500 μM ICG:HSA or ICG that was injected periareolarly directly after patent blue. The Mini-Fluorescence-Assisted Resection and Exploration (Mini-FLARE) imaging system was used for NIR fluorescence detection and quantitation. SLN mapping was successful in all patients. Patient, tumor, and treatment characteristics were equally distributed over the treatment groups. No significant difference was found in SBR between the ICG:HSA group and the ICG alone group (8.4 vs. 11.3, respectively, P = 0.18). In both groups, the average number of detected SLNs was 1.4 ± 0.5 SLNs per patient (P = 0.74). This study shows that there is no direct benefit of premixing ICG with HSA prior to injection for SLN mapping in breast cancer patients, thereby reducing the cost and complexity of the procedure. With these optimized parameters that eliminate the necessity of HSA, larger trials can now be performed to determine patient benefit.

Indexed as

AlbuminsColoring AgentsFluorescenceIndocyanine GreenAdultAgedBreast NeoplasmsDiagnostic ImagingFemaleHumansLymphatic MetastasisLymph NodesMiddle AgedAlbuminsColoring AgentsIndocyanine Green

Identifiers

PMID21360075
PMCPMC3667709
OpenAlexW2018866931

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

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.