Centre of Dermatooncology, Department of Dermatology, Eberhard-Karls-University, Tübingen, Germany.
University Department of Dermatology, Charité Universitätsmedizin Berlin, Berlin, Germany.
Br J Dermatol. 2018 Aug;179(2):478-485. doi: 10.1111/bjd.16565. Epub 2018 Jun 7.
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.
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.
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.
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.
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.
早期发现是提高黑色素瘤生存率的关键因素。目前，皮肤黑色素瘤的临床诊断主要基于视觉检查和皮肤镜检查。在新鲜切除或石蜡包埋组织的临床前研究中，已经表明，在逐步双光子激发后，即所谓的皮肤荧光检查后，皮肤黑色素瘤和黑素细胞痣之间的黑色素荧光光谱存在差异。然而，缺乏更大的前瞻性临床研究的证实。
本研究的主要终点是确定皮肤荧光检查在黑色素瘤检测中的诊断准确性。次要终点包括收集数据以改进基于黑色素荧光分类皮肤病变的计算机算法，并评估安全性方面。
这是一项针对有色素皮损（PSL）的患者进行的前瞻性、盲法、多中心临床研究，这些患者需要切除 PSL 以排除或确认皮肤黑色素瘤。所有纳入的病变均在切除前进行皮肤镜检查和体内皮肤荧光检查，并进行组织病理学检查。
共有 369 名患者和 476 个 PSL 纳入最终分析。在 476 个病变中，有 101 个（21.2%）组织病理学显示黑色素瘤。皮肤荧光检查的观察敏感性为 89.1%（101 个黑色素瘤中 90 个被识别），观察特异性为 44.8%。阳性预测值和阴性预测值分别为 30.3%和 93.9%。未发生不良事件。
皮肤荧光检查是一种安全、准确的诊断方法，可以帮助医生诊断皮肤黑色素瘤。其局限性在于缺乏足够黑色素荧光的大体无色素或退化病变。
