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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06046144
Acronym
Micro3
Enrollment
161
Registered
2023-09-21
Start date
2022-11-02
Completion date
2023-05-01
Last updated
2024-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Melanoma diagnosis, Diagnosis Imaging, Fluorescence-Advanced videodermatoscopy, Reflectance confocal microscopy, Super-high magnification dermoscopy

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.

Interventions

DIAGNOSTIC_TESTFluorescence-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.

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_TESTSuper-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.

Sponsors

Centre Hospitalier Universitaire de Saint Etienne
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

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

Secondary

MeasureTime frameDescription
Comparison of performance of imaging techniquesDay 1Analyze the results of imaging of each technique.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026