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

ConditionNaevi
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAssistance Publique Hopitaux De Marseille

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

Patients with phototype V

Patients with chronic inflammatory skin diseases

Claustrophobic patients

Patients who are bedridden or handicapped

Trial design

Design model

Single group

Treatments tested in this trial

  • Scanner of the whole body using the VECTRA 3D

    Other intervention

    Whole body image acquisition using the VECTRA 3D Whole Body 360 Imaging System to detect potential melanoma

Treatment groups

1,000 Participants
are divided into 1 treatment group
Group A: Scanner of the whole body sing the VECTRA 3DExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

development and validation of algorithms to identify lesions clinically suspected of being melanoma by a dermatologist (potentially malignant and/or ugly duckling).

Comparison of the results given by the analysis of the images by 3 dermatologists or by the software. Estimation of sensitivity and specificity thresholds of at least 93% (accuracy level 5%).

Time frame
from enrollement to until 6 month

Secondary outcomes

1

concordance rate for malignant annotations

concordance between the malignant yes-no annotations of each of the three dermatologists (2 to 2) will be tested.

Time frame
From enrollement to 6 month after
2

concordance rate for ugly duckling

concordance between the ugly duckling yes-no annotations of each of the three dermatologists (2 to 2) will be tested.

Time frame
From enrollement to 6 month after
3

calculation of the proportion of melanomas confirmed by anatomopathology

For each lesion identified as malignant or ugly duckling by the gold standard and removed for histological analysis: calculation of the proportion of melanomas confirmed by pathology.

Time frame
From enrollement to 6 month after

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: