Extensive large-scale clinical trial demonstrated the therapeutic & economic value of the VivaScope 1500 In Vivo microscope in early diagnosis of Melanoma lesions
Extensive large-scale clinical trial demonstrated the therapeutic & economic value of the VivaScope 1500 In Vivo microscope in early diagnosis of Melanoma lesions
June 2022 – In this large-scale clinical study of 3165 patients, the authors reported the effectiveness of In Vivo VivaScope microscope in early and economic diagnosis of all Melanoma lesions (>0.5 mm at baseline).
The best and most economic treatment for melanoma is achieved through technologies that offer an early and precise diagnosis. Dermoscopy is more accurate than naked eye but is limited by high rates of unnecessary excisions for histopathological confirmation. Depending on dermoscopy specialization, 5 to 30 benign lesions must be excised to detect a melanoma. Digital dermoscopy follow-up (DDF) improves the rate of melanoma diagnosis to 7% during monitoring, but still demands for better alternative technologies. The introduction of Reflectance Confocal Microscopy (RCM) enables in vivo lesion examination with higher diagnostic accuracy and specificity, particularly for equivocal lesions. However, so far, RCM clinical studies have been mainly limited to hypothetical estimates of clinical application in a small patient population and have not intended to influence clinical patient pathways. Moreover, these studies were retrospective and did not fully consider undiagnosed malignant lesions and patients’ preference for biopsy.
In this study, authors for the first time conducted an extensive clinical study with 3165 patients to assess the effectiveness of the systematic integration of a RCM, here VivaScope 1500, into the clinical and therapeutic diagnostic pathway of melanoma lesions. The study investigated adjunctive application of the VivaScope 1500 & standard cares versus standard therapeutic cares alone and considered prospective rates of deferred melanoma diagnosis, refusal to excise and loss to follow-up. The VivaScope 1500 showed the following valuable clinical advantages:
- Reduction of unnecessary excisions for histopathological confirmation by 43.4%
- Higher (almost 2-fold) melanoma positive predictive value (33.3 vs 18.9)
- Lower (almost halved) benign to malignant ratio (1.8/1.0 vs 3.7/1.0)
- Non-invasive examination of the skin in vivo, at cellular resolution and in real time
This randomized clinical trial confirms improved physicians’ diagnostic accuracy using VivaScope 1500 microscope. The VivaScope 1500 is a rapid, cost-effective, easy-to-use and single-operator microscope that provides optical biopsy of skin in real time. The microscope can be now applied systematically to the clinical diagnostic pathway of skin cancer patients.
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