Evidence map›Paper›PMID 38243410›Full record

Trial reportNeuro-oncology2024

Fluorescein-stained confocal laser endomicroscopy versus conventional frozen section for intraoperative histopathological assessment of intracranial tumors.

Arthur Wagner, Maria Charlotte Brielmaier, Charlotte Kampf, Lea Baumgart, Amir Kaywan Aftahy, Hanno S Meyer, Victoria Kehl, Julius Höhne, Karl-Michael Schebesch, Nils O Schmidt and 10 more

Open access · hybridAbstract readMulticenter StudyClinical Trial, Phase IIComparative Study
In one paragraph

Trial report in Neuro-oncology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers.

0numbers the graph read from it
0cells of the map it votes in
20citing papers in PubMed
10.9field-weighted citation impact, top 1% 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

20 citing papers in PubMed, 25 citations in OpenAlex.

  1. Article
  2. Review
  3. Article
  4. Article
  5. Review
  6. Article
  7. Real-timeFrontiers in oncology · 2026
    Article
  8. Image-Guided Brain Tumor Surgery.Recent results in cancer research. Fortschritte der Krebsforschung. Progres dans les recherches sur le cancer · 2026
    Review
  9. Review
  10. Review
  11. Aqueductal glioma surgery via a telovelar approach using sodium fluorescein in a 6-year-old pediatric patient.Child's nervous system : ChNS : official journal of the International Society for Pediatric Neurosurgery · 2025
    Review
  12. Article
  13. Review
  14. Article
  15. Article
  16. Review
  17. Article
  18. Neurooncology: 2025 update.Free neuropathology · 2025
    Review
  19. Review
  20. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

20 authors at 7 institutions in 1 country.

Arthur WagnerDepartment of Neurosurgery, Klinikum rechts der Isar Technical University Munich School of Medicine, Munich, Germany.
Maria Charlotte BrielmaierDepartment of Neurosurgery, Klinikum rechts der Isar Technical University Munich School of Medicine, Munich, Germany.
Charlotte KampfDepartment of Neurosurgery, Klinikum rechts der Isar Technical University Munich School of Medicine, Munich, Germany.
Lea BaumgartDepartment of Neurosurgery, Klinikum rechts der Isar Technical University Munich School of Medicine, Munich, Germany.
Amir Kaywan AftahyDepartment of Neurosurgery, Klinikum rechts der Isar Technical University Munich School of Medicine, Munich, Germany.
Hanno S MeyerDepartment of Neurosurgery, Klinikum rechts der Isar Technical University Munich School of Medicine, Munich, Germany.
Victoria KehlInstitute for AI and Informatics in Medicine & Muenchner Studienzentrum (MSZ), Technical University Munich School of Medicine, Munich, Germany.
Julius HöhneDepartment of Neurosurgery, Regensburg University Hospital, Regensburg, Germany.
Karl-Michael SchebeschDepartment of Neurosurgery, Regensburg University Hospital, Regensburg, Germany.
Nils O SchmidtDepartment of Neurosurgery, Regensburg University Hospital, Regensburg, Germany.
Saida ZoubaaDepartment of Neuropathology, Regensburg University Hospital, Regensburg, Germany.
Markus J RiemenschneiderDepartment of Neuropathology, Regensburg University Hospital, Regensburg, Germany.
Miriam RatliffDepartment of Neurosurgery, University Hospital Mannheim, Mannheim, Germany.ORCID 0000-0002-9464-6544
Frederik EndersDepartment of Neurosurgery, University Hospital Mannheim, Mannheim, Germany.
Andreas von DeimlingDepartment of Neuropathology, University Hospital Heidelberg and CCU Neuropathology, German Cancer Center (DKFZ), Heidelberg, Germany.ORCID 0000-0002-5863-540X
Friederike Liesche-StarneckerDepartment of Neuropathology, Pathology, Medical Faculty, University Hospital Augsburg, Augsburg, Germany.
Claire DelbridgeDepartment of Neuropathology, Klinikum rechts der Isar Technical University Munich School of Medicine, Munich, Germany.
Juergen SchlegelDepartment of Neuropathology, Klinikum rechts der Isar Technical University Munich School of Medicine, Munich, Germany.
Bernhard MeyerDepartment of Neurosurgery, Klinikum rechts der Isar Technical University Munich School of Medicine, Munich, Germany.
Jens GemptDepartment of Neurosurgery, Klinikum rechts der Isar Technical University Munich School of Medicine, Munich, Germany.ORCID 0000-0003-4123-4690
TUM Klinikum · DEUniversity Hospital Regensburg · DEHeidelberg University · DEUniversität Hamburg · DEGerman Cancer Research Center · DEInstitute for Sports Medicine · DEUniversity Hospital Augsburg · DE

Funding

Carl Zeiss Meditec AG
6 · The paper itself

Abstract

backgroundThe aim of this clinical trial was to compare Fluorescein-stained intraoperative confocal laser endomicroscopy (CLE) of intracranial lesions and evaluation by a neuropathologist with routine intraoperative frozen section (FS) assessment by neuropathology.

methodsIn this phase II noninferiority, prospective, multicenter, nonrandomized, off-label clinical trial (EudraCT: 2019-004512-58), patients above the age of 18 years with any intracranial lesion scheduled for elective resection were included. The diagnostic accuracies of both CLE and FS referenced with the final histopathological diagnosis were statistically compared in a noninferiority analysis, representing the primary endpoint. Secondary endpoints included the safety of the technique and time expedited for CLE and FS.

resultsA total of 210 patients were included by 3 participating sites between November 2020 and June 2022. Most common entities were high-grade gliomas (37.9%), metastases (24.1%), and meningiomas (22.7%). A total of 6 serious adverse events in 4 (2%) patients were recorded. For the primary endpoint, the diagnostic accuracy for CLE was inferior with 0.87 versus 0.91 for FS, resulting in a difference of 0.04 (95% confidence interval -0.10; 0.02; P = .367). The median time expedited until intraoperative diagnosis was 3 minutes for CLE and 27 minutes for FS, with a mean difference of 27.5 minutes (standard deviation 14.5; P < .001).

conclusionsCLE allowed for a safe and time-effective intraoperative histological diagnosis with a diagnostic accuracy of 87% across all intracranial entities included. The technique achieved histological assessments in real time with a 10-fold reduction of processing time compared to FS, which may invariably impact surgical strategy on the fly.

Indexed as

Brain NeoplasmsFluoresceinFrozen SectionsMicroscopy, ConfocalAdultAgedAged, 80 and overFemaleFollow-Up StudiesHumansMaleMiddle AgedPrognosisProspective StudiesYoung AdultFluoresceinbrain tumor histologyconfocal laser endomicroscopyfrozen sectionintraoperative diagnosistelepathology

Identifiers

PMID38243410
PMCPMC11066924
OpenAlexW4391055853

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.