Diagnostic accuracy of dermatofluoroscopy in cutaneous melanoma detection: results of a prospective multicentre clinical study in 476 pigmented lesions

Summary Background Early detection is a key factor in improving survival from melanoma. Today, the clinical diagnosis of cutaneous melanoma is based mostly on visual inspection and dermoscopy. Preclinical studies in freshly excised or paraffin‐embedded tissue have shown that the melanin fluorescence spectra after stepwise two‐photon excitation, a process termed dermatofluoroscopy, differ between cutaneous melanoma and melanocytic naevi. However, confirmation from a larger prospective clinical study is lacking. Objectives The primary end point of this study was to determine the diagnostic accuracy of dermatofluoroscopy in melanoma detection. Secondary end points included the collection of data for improving the computer algorithm that classifies skin lesions based on melanin fluorescence and the assessment of safety aspects. Methods This was a prospective, blinded, multicentre clinical study in patients with pigmented skin lesions (PSLs) indicated for excision either to rule out or to confirm cutaneous melanoma. All included lesions underwent dermoscopy and dermatofluoroscopy in vivo before lesions were excised and subjected to histopathological examination. Results In total, 369 patients and 476 PSLs were included in the final analysis. In 101 of 476 lesions (21·2%) histopathology revealed melanoma. The observed sensitivity of dermatofluoroscopy was 89·1% (90 of 101 melanomas identified), with an observed specificity of 44·8%. The positive and negative predictive values were 30·3% and 93·9%, respectively. No adverse events occurred. Conclusions Dermatofluoroscopy is a safe and accurate diagnostic method to aid physicians in diagnosing cutaneous melanoma. Limitations arise from largely amelanotic or regressing lesions lacking sufficient melanin fluorescence. What's already known about this topic? Dermatofluoroscopy is the analysis of melanin fluorescence spectra after stepwise two‐photon excitation. In preclinical studies dermatofluoroscopy showed a high diagnostic accuracy for detecting cutaneous melanoma. What does this study add? This is the first prospective, multicentre, clinical study investigating the diagnostic accuracy of dermatofluoroscopy for the diagnosis of melanoma in preselected pigmented skin lesions with the indication for excision to rule out or confirm melanoma. Linked Comment: Cinotti and Rubegni. Br J Dermatol 2018; 179:255–256. Respond to this article