Skin cancers represent a real public health issue. The diagnosis of pre-cancerous lesions thus is a priority. The diagnosis gold standard is based on the combination of clinical and histopathological examinations. Nevertheless, the clinical examination is not sufficiently effective, meaning that a biopsy has to be done for each suspected lesion. In order to avoid unnecessary biopsy excisions, a new medical device (DERMAPOL) was designed to help dermatologists in diagnosing skin lesions. This medical device combined with its software is a strong and ergonomic spectro-polarimetric imager instrument. It can realize images of the superficial cutaneous tissues and subcutaneous tissues close to the surface by exploiting polarized light properties. This first clinical trial aims to demonstrate that this medical device is able to segment effectively healthy and tumor tissues and that it can correlate main semiological elements (identified thanks to the clinical and histopathological examinations) to the physico-optical characteristics obtained on the images of the medical device.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
38
Use of the experimental medical device before lesion excision : skin lesion lighting (4 wavelengths) for less than 1 minute and image recording
Hôpitaux Universitaires de Strasbourg
Strasbourg, France
Proportion of lesions with semiological characteristics
Proportion of lesions for which at least one semiological characteristic (detected by the combination of visual and histopathological examinations) was identified by the medical device thanks to physico-optical properties
Time frame: Before biopsy
Physico-optical description of the lesions
Physico-optical description of the cutaneous lesions by the medical device
Time frame: Before biopsy
Number of different semiological characteristics
Number of different semiological characteristics visualized by the medical device and by the combination of clinical and histopathological examinations for each image processing
Time frame: Before biopsy
Proportion of semiological characteristics properly identified
Proportion of semiological characteristics properly identified by the medical device for all lesions
Time frame: Before biopsy
Specificity, sensitivity and predictive values
Specificity, sensitivity, true positive rate, true negative rate, false positive rate, false negative rate of the medical device, for each semiological characteristic identified by the combination of the clinical and histopathological examinations
Time frame: Before biopsy
Cases proportion for which the same semiological characteristics list was found between the medical device and the combination of clinical and histopathological diagnosis
Proportion of cases with same semiological characteristics list
Time frame: Before biopsy
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