Evidence map›Paper›PMID 26110901›Full record

Trial reportPloS one2015

The Value of Intraoperative Near-Infrared Fluorescence Imaging Based on Enhanced Permeability and Retention of Indocyanine Green: Feasibility and False-Positives in Ovarian Cancer.

Quirijn R J G Tummers, Charlotte E S Hoogstins, Alexander A W Peters, Cor D de Kroon, J Baptist M Z Trimbos, Cornelis J H van de Velde, John V Frangioni, Alexander L Vahrmeijer, Katja N Gaarenstroom

Open access · goldAbstract readClinical Trial
In one paragraph

Trial report in PloS one, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 77 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
77citing papers in PubMed, 3 pooled it
8.9field-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.

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

77 citing papers in PubMed, 3 syntheses or guidelines pooled it, 139 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. A Phase III Study of Pafolacianine Injection (OTL38) for Intraoperative Imaging of Folate Receptor-Positive Ovarian Cancer (Study 006).Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2023
    Trial
  5. Trial
  6. Article
  7. Translation of Intraoperative Molecular Imaging for Clinical Use.Journal of nuclear medicine : official publication, Society of Nuclear Medicine · 2026
    Review
  8. Erasable FAP Targeted Spray-On Probe for Fluorescence-Guided Surgery.Advanced science (Weinheim, Baden-Wurttemberg, Germany) · 2026
    Article
  9. Review
  10. Article
  11. Optical and Optoacoustic Imaging Probes.Recent results in cancer research. Fortschritte der Krebsforschung. Progres dans les recherches sur le cancer · 2026
    Review
  12. Review
  13. Article
  14. Dual-functional Anti-hPSMAApoptosis : an international journal on programmed cell death · 2025
    Article
  15. The Use of Fluorescent Markers to Detect and Delineate Head and Neck Cancer: A Scoping Review.Clinical otolaryngology : official journal of ENT-UK ; official journal of Netherlands Society for Oto-Rhino-Laryngology & Cervico-Facial Surgery · 2025
    Article
  16. Review
  17. Article
  18. Article
  19. Article
  20. Article

17 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.

Quirijn R J G TummersDepartment of Surgery, Leiden University Medical Center, Leiden, The Netherlands.
Charlotte E S HoogstinsDepartment of Surgery, Leiden University Medical Center, Leiden, The Netherlands.
Alexander A W PetersDepartment of Gynecology, Leiden University Medical Center, Leiden, The Netherlands.
Cor D de KroonDepartment of Gynecology, Leiden University Medical Center, Leiden, The Netherlands.
J Baptist M Z TrimbosDepartment of Gynecology, Leiden University Medical Center, Leiden, The Netherlands.
Cornelis J H van de VeldeDepartment of Surgery, Leiden University Medical Center, Leiden, The Netherlands.
John V FrangioniDepartment of Medicine, Division of Hematology/Oncology, Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States of America; Department of Radiology, Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States of America; Curadel, LLC, Worcester, Massachusetts, United States of America.
Alexander L VahrmeijerDepartment of Surgery, Leiden University Medical Center, Leiden, The Netherlands.
Katja N GaarenstroomDepartment of Gynecology, Leiden University Medical Center, Leiden, The Netherlands.
Leiden University Medical Center · NLCuradel (United States) · US

Funding

Intraoperative Near-Infrared Fluorescence ImagingR01CA115296 · NCI · CURADEL, LLC · PI FRANGIONI, JOHN V · 2005 to 2014
$13.9M
NCI NIH HHS R01 CA115296NCI NIH HHS R01-CA-115296
6 · The paper itself

Abstract

objectiveIn ovarian cancer, two of the most important prognostic factors for survival are completeness of staging and completeness of cytoreductive surgery. Therefore, intra-operative visualization of tumor lesions is of great importance. Preclinical data already demonstrated tumor visualization in a mouse-model using near-infrared (NIR) fluorescence imaging and indocyanine green (ICG) as a result of enhanced permeability and retention (EPR). The aim of this study was to determine feasibility of intraoperative ovarian cancer metastases imaging using NIR fluorescence imaging and ICG in a clinical setting.

methodsTen patients suspected of ovarian cancer scheduled for staging or cytoreductive surgery were included. Patients received 20 mg ICG intravenously after opening the abdominal cavity. The mini-FLARE NIR fluorescence imaging system was used to detect NIR fluorescent lesions.

results6 out of 10 patients had malignant disease of the ovary or fallopian tube, of which 2 had metastatic disease outside the pelvis. Eight metastatic lesions were detected in these 2 patients, which were all NIR fluorescent. However, 13 non-malignant lesions were also NIR fluorescent, resulting in a false-positive rate of 62%. There was no significant difference in tumor-to-background ratio between malignant and benign lesions (2.0 vs 2.0; P=0.99).

conclusionsThis is the first clinical trial demonstrating intraoperative detection of ovarian cancer metastases using NIR fluorescence imaging and ICG. Despite detection of all malignant lesions, a high false-positive rate was observed. Therefore, NIR fluorescence imaging using ICG based on the EPR effect is not satisfactory for the detection of ovarian cancer metastases. The need for tumor-specific intraoperative agents remains.

trial registrationISRCTN Registry ISRCTN16945066.

Indexed as

AdultAgedFemaleFluorescent DyesHumansIndocyanine GreenMiddle AgedMonitoring, IntraoperativeNeoplasm MetastasisOptical ImagingOvarian NeoplasmsPermeabilityFluorescent DyesIndocyanine Green

Identifiers

PMID26110901
PMCPMC4482512
OpenAlexW1570518064

What OpenQuestion holds

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LicenceCC BY
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.