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

NCT06999499 | Not Yet Recruiting

• 2 other identifiers: RCAPHM20_04382025-A01109-40
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Naevi

Outcome Measures

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%).

  from enrollement to until 6 month

Secondary Outcomes (3)

• 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

Study Arms (1)

Scanner of the whole body sing the VECTRA 3D

EXPERIMENTAL

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

Other: Scanner of the whole body using the VECTRA 3D

Interventions

Scanner of the whole body using the VECTRA 3D OTHER

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

Scanner of the whole body sing the VECTRA 3D

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (1)

Hôpital de la Conception

Marseille, 13005, France

Location

MeSH Terms

Conditions

Nevus

Condition Hierarchy (Ancestors)

Nevi and Melanomas; Neoplasms by Histologic Type; Neoplasms

Central Study Contacts

Jilliana MONNIER Dr

CONTACT

0491435817; promotion.interne@ap-hm.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2025
• First Posted: May 31, 2025
• Study Start: March 1, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: November 18, 2025

Record last verified: 2025-11

Locations

FR (1)