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Not yet recruiting NCT06999499

Development of an Aid to Melanoma Detection Using Artificial Intelligence Algorithms Based on Images From the VECTRA 3D System.

No phase Interventional Naevi

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Scanner of the whole body using the VECTRA 3D.
Who it may be relevant to
Registry conditions: Naevi. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Development of Artificial Intelligence Algorithms to Help Detect Potential Melanomas, Using Images From the VECTRA 3D Whole Body 360 Imaging System, a 3D Whole-body Skin Scanner.

Overview

The background to this research is that frequent medical screening of the general population for melanoma is not feasible. The real challenge of this project is to develop an automatic process for detecting any potential melanoma. To this end, the project aims to design an algorithm to build a novel diagnostic aid that makes use of the similarity and disparity of pigmented lesions in the same patient. To achieve this, we need to obtain and structure a large database of images grouping all pigmented lesions per patient according to their similarities as perceived by dermatologists.

Interventions

  • Other Scanner of the whole body using the VECTRA 3D
    Whole body image acquisition using the VECTRA 3D Whole Body 360 Imaging System to detect potential melanoma

Primary outcome measures

  • development and validation of algorithms to identify lesions clinically suspected of being melanoma by a dermatologist (potentially malignant and/or ugly duckling). [Time frame: from enrollement to until 6 month]
Secondary outcome measures (3)
  • concordance rate for malignant annotations [Time frame: From enrollement to 6 month after]
  • concordance rate for ugly duckling [Time frame: From enrollement to 6 month after]
  • calculation of the proportion of melanomas confirmed by anatomopathology [Time frame: From enrollement to 6 month after]

Eligibility criteria

Inclusion criteria

  • Male or female aged 18 and over
  • Patient with more than 15 nevi (moles) of various phototypes (I to III)
  • Patient who has received information about the study and has not expressed any opposition
  • Patient who is a beneficiary or entitled person under a social security scheme

Exclusion criteria

  • Patients with phototype V
  • Patients with chronic inflammatory skin diseases
  • Claustrophobic patients
  • Patients who are bedridden or handicapped
  • Patients who are excluded from another research protocol at the time of collection of the non-objection.
  • Patients covered by articles L1121-5 to 1121-8 of the French Public Health Code (minors, adults under guardianship or trusteeship, patients deprived of their liberty, pregnant or breast-feeding women),
  • Any other reason which, in the investigator's opinion, could interfere with the evaluation of the research objectives.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

France · 1 center
  • Hôpital de la Conception — Marseille

Identifiers

NCT: NCT06999499 · RCAPHM20_0438 · 2025-A01109-40

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗