Comparison of 3 in Vivo Microscopic Imaging Techniques for the Diagnosis of Pigmented Tumors (Micro3)

Centre Hospitalier Universitaire de Saint Etienne

Status: Completed

Conditions: Lentigo; Melanoma; Lentigo Maligna; Nevus; Seborrheic Keratosis; Basal Cell Carcinoma

Treatments: Diagnostic Test: Fluorescence-Advanced videodermatoscopy; Diagnostic Test: Reflectance confocal microscopy; Diagnostic Test: Super-high magnification dermoscopy

Study type: Observational

Funder types: Other

Identifiers

NCT06046144

IRBN1142023/CHUSTE

Details and patient eligibility

About

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 Reflectance confocal microscopy (RCM), it currently use 2 less expensive dermatoscopes that also allow in vivo diagnosis: super-high magnification dermoscopy (D400) and Fluorescence-Advanced videodermatoscopy (FAV).

Full description

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.

Enrollment: 161 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

161 participants in 1 patient group

Patients with a pigmented skin lesion

Description:

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.

Treatment:

Diagnostic Test: Super-high magnification dermoscopy

Diagnostic Test: Reflectance confocal microscopy

Diagnostic Test: Fluorescence-Advanced videodermatoscopy