Methyl aminolevulinate-PpIX mediated fluorescence-guided mapping of high-grade vulvar intraepithelial neoplasia: a pilot prospective clinical trial (PhotoDiVin).
Lorraine Hejl, Marion Helle, Léa Leufflen et al.
✦ AI-curated · Sources linked
In 30 seconds
This prospective, single-centre, single-arm pilot clinical trial assessed methyl aminolevulinate-mediated fluorescence mapping in 17 women with histologically confirmed high-grade vulvar intraepithelial neoplasia (dVIN or vHSIL). After topical application, lesions were examined under 405-nm light, and targeted biopsies were compared with histopathology. Findings were concordant in 91% of 34 biopsies; fluorescence correctly identified intraepithelial neoplasia in 14 patients, a success rate of 82% (95%CI 56-96%). The authors describe the approach as workable but call for further studies to improve reproducibility and ease of use.
Key findings
- Histopathology and fluorescence findings were concordant in 91% of 34 biopsies.
- Fluorescence correctly identified intraepithelial neoplasia in 14 patients, with a success rate of 82% (95%CI 56-96%).
- Sensitivity was 93% (95%CI 68-100%) and specificity was 89% (95%CI 67-99%).
- The procedure was reported as well tolerated, with no pain or side effects after cream application or illumination.
Why it matters
High-grade vulvar intraepithelial neoplasia can recur, and positive surgical margins are an important recurrence-risk criterion. Fluorescence-guided mapping may help identify lesion areas for assessment, but these pilot results establish feasibility rather than clinical benefit. The reported diagnostic performance and tolerability support further evaluation of the method in larger studies.
What to keep in mind
This was a small, single-centre, single-arm pilot trial; the authors note that reproducibility and ease of use require improvement.