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

• ClinicalTrials.gov Identifier: NCT06046144
• Recruitment Status: Completed
• First Posted: September 21, 2023
• Last Update Posted: September 21, 2023
• Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Information provided by (Responsible Party): Centre Hospitalier Universitaire de Saint Etienne

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
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: November 2, 2022
• Actual Primary Completion Date: May 1, 2023
• Actual Study Completion Date: May 1, 2023

Groups and Cohorts

Group/Cohort

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.

Outcome Measures

Primary Outcome Measures :

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

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

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

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.

Criteria

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

Contacts and Locations

Locations

France

Chu de Saint Etienne

Saint Etienne, France, 42000

Sponsors and Collaborators

Centre Hospitalier Universitaire de Saint Etienne

Investigators

• Principal Investigator: Jean-Luc PERROT, MD PhD; CHU Saint-Etienne

More Information

• Responsible Party: Centre Hospitalier Universitaire de Saint Etienne
• ClinicalTrials.gov Identifier: NCT06046144
• Other Study ID Numbers: IRBN1142023/CHUSTE
• First Posted: September 21, 2023
• Last Update Posted: September 21, 2023
• Last Verified: August 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Centre Hospitalier Universitaire de Saint Etienne:

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

Additional relevant MeSH terms:

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