Evidence map›Paper›PMID 22796548›Full record

Trial reportGynecologic oncology2012

Randomized comparison of near-infrared fluorescence lymphatic tracers for sentinel lymph node mapping of cervical cancer.

Boudewijn E Schaafsma, Joost R van der Vorst, Katja N Gaarenstroom, Alexander A W Peters, Floris P R Verbeek, Cornelis D de Kroon, J Baptist M Z Trimbos, Mariette I E van Poelgeest, John V Frangioni, Cornelis J H van de Velde and 1 more

Registry-linked trialAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Gynecologic oncology, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02690259 (Near Infrared Fluorescent Technique for Sentinel Lymph Node Mapping in Endometrial Cancer), which is not on this map. Cited by 38 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
38citing papers in PubMed, 5 pooled it
8.3field-weighted citation impact, top 2% 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.

NCT02690259 nacompletednot on this mapstarted 2014, after this paper: background citation

Near Infrared Fluorescent Technique for Sentinel Lymph Node Mapping in Endometrial Cancer

TypeinterventionalSponsorRegion SkaneRan2014 to 2018Enrolled257ConditionsEndometrial NeoplasmsArmsSentinel node procedure
3 · Its place in the literature

Who cites it

38 citing papers in PubMed, 5 syntheses or guidelines pooled it, 81 citations in OpenAlex.

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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

11 authors at 2 institutions in 2 countries.

Boudewijn E SchaafsmaDepartment of Surgery, Leiden University Medical Center, Leiden, The Netherlands.
Joost R van der Vorst
Katja N Gaarenstroom
Alexander A W Peters
Floris P R Verbeek
Cornelis D de Kroon
J Baptist M Z Trimbos
Mariette I E van Poelgeest
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

objectiveNear-infrared fluorescence imaging using indocyanine green (ICG) has recently been introduced as a novel technique for sentinel lymph node (SLN) mapping in early-stage cervical cancer. Although preclinical research has shown that ICG adsorbed to human serum albumin (ICG:HSA) improves its performance, the need for HSA has not yet been confirmed in cervical cancer patients. The current randomized study aims to determine whether ICG:HSA offers advantages over using ICG alone.

methodsEighteen consecutive early-stage cervical cancer patients scheduled to undergo pelvic lymphadenectomy were included. Prior to surgery, 1.6 mL of 500 μM ICG:HSA or 500 μM ICG alone was injected transvaginally in 4 quadrants around the tumor. The Mini-FLARE imaging system was used for intraoperative NIR fluorescence detection and quantitation.

resultsSLNs were identified intraoperatively in 78% of the patients. Patient and tumor characteristics were equally distributed over both treatment groups. No significant difference in signal-to-background ratio (9.3 vs. 10.1, P=.72) or average number of detected SLNs (2.9 vs 2.7, P=.84) was found between the ICG:HSA group and the ICG alone group, respectively.

conclusionsIn conclusion, this double-blind, randomized trial showed no advantage of ICG:HSA over ICG alone for the SLN procedure in early-stage cervical cancer. Further optimization is required to improve the intraoperative detection rate.

Indexed as

Indocyanine GreenAdultAgedColoring AgentsDiagnostic ImagingDouble-Blind MethodFemaleFluorescent DyesHumansInfrared RaysIntraoperative CareLymphatic MetastasisLymph NodesMicroscopy, FluorescenceMiddle AgedNeoplasm StagingColoring AgentsFluorescent DyesIndocyanine GreenSerum Albumin

Identifiers

PMID22796548
PMCPMC3432653
OpenAlexW2057103966

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

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.