Clinical trial NCT03796871: Medical Device Based on Polarized Light for Cutaneous Lesions Visualization
Official title: Interest of a New Medical Device for the Visualization of Cutaneous Lesions Based on Polarized Light
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Skin Lesion
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2019-01-08
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* adult patient with a skin tumor (benign or cancerous) which has to be excised and analysed according to histopathological examination
* skin lesion belonging to one of these groups (diagnosed by clinical examination):

  * cutaneous cyst
  * seborrhoeic keratosis
  * cutaneous carcinoma
  * naevus
  * melanoma
  * actinic keratosis and cutaneous horn
  * other skin tumors
* skin lesion size equal to or less than 5 cm
* signed written consent form
* patient affiliated to a social insurance

Exclusion Criteria:

* skin lesion size strictly over than 5 cm
* eyelid lesion
* aluminium, POM (polyoxymethylene) or organic glass allergy
* known pregnancy, breast-feeding

Primary outcomes:
measure: Proportion of lesions with semiological characteristics
timeFrame: Before biopsy
Secondary outcomes:
measure: Physico-optical description of the lesions
timeFrame: Before biopsy
measure: Number of different semiological characteristics
timeFrame: Before biopsy
measure: Proportion of semiological characteristics properly identified
timeFrame: Before biopsy
measure: Specificity, sensitivity and predictive values
timeFrame: Before biopsy
measure: Cases proportion for which the same semiological characteristics list was found between the medical device and the combination of clinical and histopathological diagnosis
timeFrame: Before biopsy
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Hôpitaux Universitaires de Strasbourg
Study officials:
affiliation: Hôpitaux Universitaires de Strasbourg
name: Bernard CRIBIER, MD
role: PRINCIPAL_INVESTIGATOR
References: