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

NCT ID: NCT06999499

Last Updated: 2025-05-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

1000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-01

Study Completion Date

2027-12-01

Brief Summary

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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.

Detailed Description

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Conditions

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Naevi

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Scanner of the whole body using the VECTRA 3D

Intervention Type OTHER

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

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Assistance Publique Hopitaux De Marseille

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hôpital de la Conception

Marseille, , France

Site Status

Countries

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France

Central Contacts

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Jilliana MONNIER Dr

Role: CONTACT

Phone: 0491435817

Email: [email protected]

Facility Contacts

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Jilliana MONNIER Dr

Role: primary

Other Identifiers

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2025-A01109-40

Identifier Type: OTHER

Identifier Source: secondary_id

RCAPHM20_0438

Identifier Type: -

Identifier Source: org_study_id