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

Sponsor

Centre Hospitalier Universitaire de Saint Etienne (Other)

Overall Status

Completed

CT.gov ID

NCT06046144

Collaborator

(none)

161

Enrollment

Location

5.9

Actual Duration (Months)

27.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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).

Condition or Disease	Intervention/Treatment	Phase
Basal Cell Carcinoma Lentigo Maligna Melanoma Nevus Seborrheic Keratosis Lentigo	Diagnostic Test: Fluorescence-Advanced videodermatoscopy Diagnostic Test: Reflectance confocal microscopy Diagnostic Test: Super-high magnification dermoscopy

Detailed 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.

Study Design

Study Type:

Observational

Actual Enrollment :

161 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Nov 2, 2022

Actual Primary Completion Date :

May 1, 2023

Actual Study Completion Date :

May 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Patients with a pigmented skin lesion 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 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. Diagnostic Test: Reflectance confocal microscopy 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. Diagnostic Test: Super-high magnification dermoscopy 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.

Arm

Intervention/Treatment

Patients with a pigmented skin lesion

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

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.

Diagnostic Test: Reflectance confocal microscopy

Diagnostic Test: Super-high magnification dermoscopy

Outcome Measures

Primary Outcome Measures

To analyse the picture to assess the relevance of each technique for the diagnostic of malignant and benign pigmented lesions. [Day 1]
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.

Secondary Outcome Measures

Comparison of different imaging techniques [Day 1]
To compare the performance of combination of 2 techniques to assess if the performance is better than 1 technique alone.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts 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.