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

Melanoma Clinical Trial

— Micro3  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06046144
• Other study ID #: IRBN1142023/CHUSTE
• Status: Completed
• Start date: November 2, 2022
• Est. completion date: May 1, 2023

Study information

• Verified date: August 2023
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 161
• Est. completion date: May 1, 2023
• Est. primary completion date: May 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
France	Chu de Saint Etienne	Saint Etienne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To analyse the picture to assess the relevance of each technique for the diagnostic of malignant and benign pigmented lesions.	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.	Day 1
Secondary	Comparison of different imaging techniques	To compare the performance of combination of 2 techniques to assess if the performance is better than 1 technique alone.	Day 1