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Completed

NCT Number: NCT06046144

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

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).

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Key information

Conditions

Basal Cell Carcinoma Carcinoma Carcinoma, Basal Cell Hutchinson's Melanotic Freckle Hyperpigmentation Keratosis Keratosis, Seborrheic Lentigo Lentigo Maligna Melanoma Melanosis Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Basal Cell Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Nevus Pigmentation Disorders Seborrheic Keratosis Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Chu de Saint Etienne

Saint-Etienne, 42000, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fluorescence-Advanced videodermatoscopy

Diagnostic Test

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.

Reflectance Confocal Microscopy

Diagnostic Test

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.

Super-high magnification dermoscopy

Diagnostic Test

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.

Primary outcomes

  1. To compare the the relevance of each technique for the diagnostic of pigmented lesions.

    Time frame: Day 1

    The nature of the tumor is diagnosed by the imaging technique.

Secondary outcomes

  1. Comparison of performance of imaging techniques

    Time frame: Day 1

    Analyze the results of imaging of each technique.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Registry information

Official study title

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

Acronym: Micro3

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Sep 21, 2023
Registry last updated
Jun 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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