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.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 1,000
- Locations
- 2
- Primary Endpoint
- development and validation of algorithms to identify lesions clinically suspected of being melanoma by a dermatologist (potentially malignant and/or ugly duckling).
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
Scanner of the whole body sing the VECTRA 3D
Whole body image acquisition using the VECTRA 3D Whole Body 360 Imaging System to detect potential melanoma
Intervention: Scanner of the whole body using the VECTRA 3D (Other)
Outcomes
Primary Outcomes
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
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%).
Secondary Outcomes
- concordance rate for malignant annotations(From enrollement to 6 month after)
- concordance rate for ugly duckling(From enrollement to 6 month after)
- calculation of the proportion of melanomas confirmed by anatomopathology(From enrollement to 6 month after)