Evidence map›Paper›PMID 41309506›Full record

Trial reportBJU international2026

The LaserSAFE technique for margin assessment during radical prostatectomy: a feasibility study.

Ricardo Almeida-Magana, Larissa Sena Teixeira Mendes, Eoin Dinneen, Tarek Al-Hammouri, Aiman Haider, Anna Silvanto, Alex Freeman, Nicholas Roberts, Louise Dickinson, Chun Wah So and 6 more

Registry-linked trialAbstract readClinical Trial, Phase IClinical Trial, Phase IIMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BJU international, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06398470 (A Feasibility Trial to Evaluate Margin Status During Radical Prostatectomy With En-face Fluorescence Confocal Microscopy), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact
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.

NCT06398470 phase1 / phase2completednot on this map

A Feasibility Trial to Evaluate Margin Status During Radical Prostatectomy With En-face Fluorescence Confocal Microscopy (LaserSAFE) Compared to NeuroSAFE

TypeinterventionalSponsorUniversity College, LondonRan2024 to 2025Enrolled21ConditionsProstate CancerArmsNeuroSAFE procedure, LaserSAFE procedure
3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Review
  2. Article
  3. Review
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

16 authors.

Ricardo Almeida-MaganaDivision of Medicine and Interventional Science, Department of Targeted Intervention, Faculty of Medical Sciences, University College London, London, UK.ORCID 0000-0002-3437-1649
Larissa Sena Teixeira MendesDivision of Medicine and Interventional Science, Department of Targeted Intervention, Faculty of Medical Sciences, University College London, London, UK.
Eoin DinneenDivision of Medicine and Interventional Science, Department of Targeted Intervention, Faculty of Medical Sciences, University College London, London, UK.
Tarek Al-HammouriDivision of Medicine, Centre for Medical Imaging, University College London, London, UK.
Aiman HaiderDepartment of Pathology, University College London NHS Foundation Trust, London, UK.
Anna SilvantoDepartment of Pathology, University College London NHS Foundation Trust, London, UK.
Alex FreemanDepartment of Pathology, University College London NHS Foundation Trust, London, UK.
Nicholas RobertsDivision of Medicine and Interventional Science, Department of Targeted Intervention, Faculty of Medical Sciences, University College London, London, UK.
Louise DickinsonDepartment of Radiology, University College London NHS Foundation Trust, London, UK.
Chun Wah SoDepartment of Radiology, University College London NHS Foundation Trust, London, UK.
Zafer TandogduDepartment of Urology, University College London NHS Foundation Trust, London, UK.
Benjamin W LambDepartment of Urology, University College London NHS Foundation Trust, London, UK.ORCID 0000-0003-2220-893X
Nikhil MayorDepartment of Surgery and Cancer, Faculty of Medicine, Imperial College London, London, UK.
Mathias WinklerDepartment of Surgery and Cancer, Faculty of Medicine, Imperial College London, London, UK.
Hashim AhmedDepartment of Surgery and Cancer, Faculty of Medicine, Imperial College London, London, UK.ORCID 0000-0003-1674-6723
Greg ShawDivision of Medicine and Interventional Science, Department of Targeted Intervention, Faculty of Medical Sciences, University College London, London, UK.

Funding

Royal College of Surgeons of England
6 · The paper itself

Abstract

objectivesTo assess the feasibility of conducting a multicentre trial comparing NeuroSAFE with a novel technique based on confocal laser microscopy (LaserSAFE) and evaluate the diagnostic performance of LaserSAFE for real-time surgical margin assessment. PATIENTS AND

methodsThis was a non-randomised, prospective feasibility study conducted at a high-volume academic UK centre (ClinicalTrials.gov identifier: NCT06398470). Patients with localised prostate cancer (clinical T2-T3a N0 M0) scheduled for robot-assisted radical prostatectomy and deemed unsuitable for bilateral intrafascial nerve sparing (NS) based on a multidisciplinary plan were included. LaserSAFE imaging was performed in the operating room after which the NeuroSAFE technique results guided NS decisions. Pathologists, blinded to NeuroSAFE and final histology, retrospectively evaluated LaserSAFE images. Diagnostic accuracy metrics and concordance between modalities were calculated. Feasibility was assessed based on recruitment rate and the ability to activate additional sites.

resultsA total of 20 patients were recruited at a single site within 12 months of recruitment start. However, expansion to additional centres was not feasible due to limitations in implementing the NeuroSAFE protocol. LaserSAFE achieved a sensitivity of 0.91 (95% confidence interval [CI] 0.59-1.00) and specificity of 1.00 (95% CI 0.88-1.00) for detecting positive surgical margins ≥0.5 mm. Cohen's kappa demonstrated strong agreement with NeuroSAFE and final pathology. LaserSAFE was completed within a median of 7 min, significantly shorter than the 63 min required for NeuroSAFE. Limitations include the small sample size, single-centre setting, and lack of intraoperative decision-making based on LaserSAFE findings.

conclusionWhile a multicentre study based on NeuroSAFE as a comparison was not achievable, LaserSAFE proved to be a rapid and accurate alternative for intraoperative margin assessment. These findings support the design of a larger trial in which NS decisions are informed by LaserSAFE, with a view to broadening access to real-time margin assessment.

Indexed as

Margins of ExcisionProstatectomyProstatic NeoplasmsAgedFeasibility StudiesHumansMaleMicroscopy, ConfocalMiddle AgedProspective Studiesfeasibility studyfluorescence confocal microscopyintraoperative margin assessmentprostate cancerradical prostatectomy

Identifiers

PMID41309506
PMCPMC13314559

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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.