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CompletedNCT06046144Micro3Updated Jun 24, 2024

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

An observational study in Basal Cell Carcinoma, Lentigo Maligna and Melanoma, sponsored by Centre Hospitalier Universitaire de Saint Etienne. Completed at 1 site in France. Per ClinicalTrials.gov, last updated 2024-06-24.

Sponsored by Centre Hospitalier Universitaire de Saint Etienne · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
161
Sex
All
01

Study 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).

Read the 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.

02

Conditions studied

  • 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
03

In context

Carcinoma, Basal Cell

389 studies on the registry are indexed under Carcinoma, Basal Cell; 69 are open to participants now.

This study's enrollment of 161 is above the median of 142 across 95 observational studies indexed under Carcinoma, Basal Cell.

Browse Carcinoma, Basal Cell studies →

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne is the lead sponsor of 597 studies on the registry; 127 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Bad quality images
  • Insufficient number of images
  • Uncertain diagnosis given by the pathologist
  • Refusal
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
161 participants (actual)
Patient registry
No

Groups and cohorts

  • 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 · Diagnostic Test: Reflectance confocal microscopy · Diagnostic Test: Super-high magnification dermoscopy

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.

  • Diagnostic testReflectance 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 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.

06

What researchers measure

Primary outcomes

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

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

    Time frame: Day 1

Secondary outcomes

  1. Comparison of performance of imaging techniques

    Analyze the results of imaging of each technique.

    Time frame: Day 1

07

Study locations

1 site
  • Chu de Saint Etienne
    Saint Etienne, 42000, France
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 24, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06046144
Responsible party
Sponsor
First posted
Sep 21, 2023
Start date
Nov 2, 2022
Primary completion
May 1, 2023
Completion
May 1, 2023
Last update
Jun 24, 2024

Study contacts

Jean-Luc PERROT, MD PhD
principal investigator · CHU Saint-Etienne

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.

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