Comparison of 3 in Vivo Microscopic Imaging Techniques for the Diagnosis of Pigmented Tumors

Study Overview
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Brief Summary
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Reflectance confocal microscopy (RCM) is the reference in vivo imaging technique for identifying malignant melanocytic tumors prior to surgical excision. However, it is not widely used due to its high cost and highly technical and time-consuming nature. In addition to RCM, we currently use 2 less expensive dermatoscopes that also allow in vivo diagnosis: super-high magnification dermoscopy (D400) and Fluorescence-Advanced videodermatoscopy (FAV).

Detailed Description
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Several studies have demonstrated their interest in the in vivo diagnosis of melanocytic tumors, but without any comparison between these methods. In our current practice, many patients have benefited from these 3 imaging modalities for benign and malignant lesions. Therefore, our aim is to analyze these images and compare their performance in the diagnosis of benign and malignant pigmented lesions.

Official Title
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Comparison of 3 in Vivo Microscopic Imaging Techniques for the Diagnosis of Pigmented Tumors. Monocentric Retrospective Study of 170 Tumors

Conditions
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Nevus, Basal Cell Carcinoma, Lentigo Maligna, Melanoma, Seborrheic Keratosis, Lentigo

Intervention / Treatment
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* Diagnostic Test: Fluorescence-Advanced videodermatoscopy
* Diagnostic Test: Reflectance confocal microscopy
* Diagnostic Test: Super-high magnification dermoscopy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with a pigmented skin lesion of more than 3mm diameter which have benefited systematically of all 3 imaging techniques at the same time, followed by either a surgical excision or annual imaging monitoring. Exclusion Criteria: Bad quality images Insufficient number of images Uncertain diagnosis given by the pathologist Refusal
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with a pigmented skin lesion<br>Patients with a pigmented skin lesion of more than 3mm diameter which have benefited systematically of all 3 imaging techniques at the same time, followed by either a surgical excision or annual imaging monitoring. | Diagnostic Test: Fluorescence-Advanced videodermatoscopy<br>* Datas collected : Presence or absence of atypical roundish cell, dendritic cell, atypical nests, points, folliculotropism, blue homogenous zone, regular honeycomb pattern. Between 10 and 60 images taken by a hand-held camera set directly on the skin lesion, with an oily interface.<br>Diagnostic Test: Reflectance confocal microscopy<br>* Datas collected : Presence or absence of atypical roundish cell, dendritic cell, atypical nests, points, folliculotropism, blue homogenous zone, regular honeycomb pattern. Between 10 and 60 images taken by a hand-held camera set directly on the skin lesion, with an oily interface.<br>Diagnostic Test: Super-high magnification dermoscopy<br>* Datas collected : Presence or absence of atypical roundish cell, dendritic cell, atypical nests, points, folliculotropism, blue homogenous zone, regular honeycomb pattern. Between 10 and 60 images taken by a hand-held camera set directly on the skin lesion, with an oily interface.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To analyse the picture to assess the relevance of each technique for the diagnostic of malignant and benign pigmented lesions. | The nature of the tumor is diagnosed by an imaging technique if we can find on the images the main characteristics belonging to a certain tumor. After this we can calculate the sensitivity, specificity of each technique. | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of different imaging techniques | To compare the performance of combination of 2 techniques to assess if the performance is better than 1 technique alone. | Day 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Melanoma diagnosis, Diagnosis Imaging, Fluorescence-Advanced videodermatoscopy, Reflectance confocal microscopy, Super-high magnification dermoscopy