Methyl aminolevulinate-PpIX mediated fluorescence-guided mapping of high-grade vulvar intraepithelial neoplasia: a pilot prospective clinical trial (PhotoDiVin).
7 affiliations
- 1Département de chirurgie, Institut de Cancérologie de Lorraine, Vandœuvre-lès-Nancy, France. [email protected].
- 2Département de Maïeutique, Université de Lorraine, Nancy, France.
- 3Département de chirurgie, Institut de Cancérologie de Lorraine, Vandœuvre-lès-Nancy, France.
- 4Département de chirurgie, Clinique du Val de l'Ouest, Ecully, France.
- 5Département de Statistiques, Institut de Cancérologie de Lorraine, Vandœuvre-lès-Nancy, France.
- 6Département de Recherche, Institut de Cancérologie de Lorraine, Vandœuvre-lès-Nancy, France.
- 7Centre de Recherche en Automatique de Nancy, Centre National de la Recherche Scientique UMR 7039, Université de Lorraine, Nancy, France.
Abstract
Background
The worldwide prevalence of vulvar intraepithelial neoplasia is increasing and is characterized by the high risk of recurrence and evolution towards vulvar cancer. Positive margins following surgical excision are the most important criteria of recurrence risk. We conducted a pilot clinical study to assess the fluorescence-based cartography of VIN lesions using methyl aminolevulinate (m-ALA), which is a prodrug of the fluorophore protoporphyrin IX (PpIX). A prospective, single-center, single-arm clinical trial included 17 women with histologically confirmed high-grade vulvar intraepithelial neoplasia (dVIN or vHSIL). Following topical methyl aminolevulinate application, fluorescence-guided examination under 405-nm light was performed. Targeted biopsies from fluorescent and non-fluorescent areas were compared with histopathology to assess concordance and the ability of fluorescence to accurately identify high-grade lesions. Among 34 biopsies, histopathological findings were concordant with fluorescence in 91% of cases. The procedure correctly identified intraepithelial neoplasia areas in 14 patients, yielding a success rate of 82% (95%CI 56-96%). Sensitivity and specificity were 93% (95%CI 68-100%) and 89% (95%CI 67-99%), respectively. The tolerance of the procedure was excellent with no pain and no side effects neither after cream application nor after illumination. This pilot study suggests that fluorescence imaging is a workable technique to mark VIN lesions with m-ALA cream. Further studies are needed to improve the reproducibility and ease of use of this method.
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BibTeX
@article{hejl2026methyl,
title = {{Methyl aminolevulinate-PpIX mediated fluorescence-guided mapping of high-grade vulvar intraepithelial neoplasia: a pilot prospective clinical trial (PhotoDiVin).}},
author = {Lorraine Hejl and Marion Helle and Léa Leufflen and Aboubacar Diallo and Manuel Gomes David and Marion Pierret and Maxime Richard and Thierry Routiot and Nour Mammari and Henri-Pierre Lassalle and Fréderic Marchal and Julia Salleron and Lina Bezdetnaya},
journal = {Lasers in medical science},
year = {2026},
month = oct,
doi = {10.1007/s10103-026-05047-4},
url = {https://europepmc.org/article/MED/42955379},
note = {CC BY-NC-ND},
}
RIS
TY - JOUR
TI - Methyl aminolevulinate-PpIX mediated fluorescence-guided mapping of high-grade vulvar intraepithelial neoplasia: a pilot prospective clinical trial (PhotoDiVin).
AU - Lorraine Hejl
AU - Marion Helle
AU - Léa Leufflen
AU - Aboubacar Diallo
AU - Manuel Gomes David
AU - Marion Pierret
AU - Maxime Richard
AU - Thierry Routiot
AU - Nour Mammari
AU - Henri-Pierre Lassalle
AU - Fréderic Marchal
AU - Julia Salleron
AU - Lina Bezdetnaya
PY - 2026
DA - 2026/10/29
JO - Lasers in medical science
DO - 10.1007/s10103-026-05047-4
UR - https://europepmc.org/article/MED/42955379
AB - Background The worldwide prevalence of vulvar intraepithelial neoplasia is increasing and is characterized by the high risk of recurrence and evolution towards vulvar cancer. Positive margins following surgical excision are the most important criteria of recurrence risk. We conducted a pilot clinical study to assess the fluorescence-based cartography of VIN lesions using methyl aminolevulinate (m-ALA), which is a prodrug of the fluorophore protoporphyrin IX (PpIX). A prospective, single-center, single-arm clinical trial included 17 women with histologically confirmed high-grade vulvar intraepithelial neoplasia (dVIN or vHSIL). Following topical methyl aminolevulinate application, fluorescence-guided examination under 405-nm light was performed. Targeted biopsies from fluorescent and non-fluorescent areas were compared with histopathology to assess concordance and the ability of fluorescence to accurately identify high-grade lesions. Among 34 biopsies, histopathological findings were concordant with fluorescence in 91% of cases. The procedure correctly identified intraepithelial neoplasia areas in 14 patients, yielding a success rate of 82% (95%CI 56-96%). Sensitivity and specificity were 93% (95%CI 68-100%) and 89% (95%CI 67-99%), respectively. The tolerance of the procedure was excellent with no pain and no side effects neither after cream application nor after illumination. This pilot study suggests that fluorescence imaging is a workable technique to mark VIN lesions with m-ALA cream. Further studies are needed to improve the reproducibility and ease of use of this method.
SN - 0268-8921
SN - 1435-604X
ER -