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Second-Generation Wide-Field Visualization Devices for 5-ALA-Induced Fluorescence and Concepts for Validation in

Zeynep Özdemir1, Eric Suero Molina1, Sönke J Hellwig1

  • 1Department of Neurosurgery, University Hospital of Münster, Münster, Germany.

Neurosurgery Practice
|February 17, 2025
PubMed
Summary

New technologies for fluorescence-guided resection (FGR) using five-aminolevulinic acid (5-ALA) require standardized validation. Current methods often lack standardization, impacting the reliability of new devices for malignant glioma surgery.

Keywords:
5-ALADevice validationFilter systemFluorescence-guidanceFluorescence-guided resection

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Area of Science:

  • Neurosurgery
  • Surgical Oncology
  • Medical Imaging

Background:

  • Fluorescence-guided resection (FGR) with five-aminolevulinic acid (5-ALA) is standard for malignant gliomas.
  • New visualization technologies have emerged for 5-ALA-mediated FGR.
  • Evaluating the clinical efficacy of these new technologies requires robust validation.

Purpose of the Study:

  • To review current technologies for 5-ALA-mediated FGR.
  • To analyze the validation concepts and methodologies used for novel devices.
  • To highlight the need for standardized validation in FGR.

Main Methods:

  • Systematic review adhering to PRISMA guidelines.
  • Identification of devices detecting 5-ALA-induced fluorescence.
  • Qualitative analysis of validation methods in 22 selected studies.

Main Results:

  • Reviewed devices include Leica FL400, Aesculap Aeos, Zeiss BLUE400, Karl Storz D-Light C, Machida N-4L, Olympus ORBEYE, and custom loupes.
  • Validation methods across studies were frequently unstandardized.
  • Inherent biases and limited reproducibility were noted in device validation.

Conclusions:

  • Device validation is crucial for FGR, particularly for 5-ALA applications.
  • The BLUE400 filter system serves as a benchmark for validation, used in 5-ALA approval studies.
  • Standardized validation concepts are essential to confirm the reliability and superiority of new FGR devices.