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

Completed

• Conditions: Basal Cell Carcinoma; Melanoma; Seborrheic Keratosis; Nevus; Lentigo Maligna; Lentigo
• Interventions: Diagnostic Test: Fluorescence-Advanced videodermatoscopy; Diagnostic Test: Reflectance confocal microscopy; Diagnostic Test: Super-high magnification dermoscopy

• Registration Number: NCT06046144
• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne

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 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).

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 Timeline

• Study Start: 2022-11-02
• Primary Completion: 2023-05-01
• Study Completion: 2023-05-01
• Status Verified: 2023-08
• Study First Submitted: 2023-09-14
• Study First Submitted QC: 2023-09-14
• Study First Posted: 2023-09-21
• Last Update Submitted: 2024-06-20
• Last Update Posted: 2024-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 161

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with a pigmented skin lesion	Fluorescence-Advanced videodermatoscopy	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.
Patients with a pigmented skin lesion	Reflectance confocal microscopy	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.
Patients with a pigmented skin lesion	Super-high magnification dermoscopy	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.

Primary Outcome Measures

Name	Time	Method
To compare the the relevance of each technique for the diagnostic of pigmented lesions.	Day 1	The nature of the tumor is diagnosed by the imaging technique.

Secondary Outcome Measures

Name	Time	Method
Comparison of performance of imaging techniques	Day 1	Analyze the results of imaging of each technique.

Trial Locations

Locations (1)

Chu de Saint Etienne; 🇫🇷 Saint Etienne, France