NCT04605822

Melanoma Detection in Switzerland With VECTRA

Clinical Performance of the New Artificial-intelligence Powered 3D Total Body Photography System VECTRA® in Early Melanoma Detection and Its Impact on Patients' Burden of Disease: A Prospective Cohort Study in a Real-world Setting

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 455 (actual)
• Sponsor: University Hospital, Basel, Switzerland · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is to compare 2D- and 3D-imaging and routine clinical care in early melanoma detection in a prospective large-scale real-world data set.

Detailed description

This study is to compare the accuracy of combining human and artificial intelligence with its independent application in early melanoma detection. The Artificial Intelligence (AI)-powered 3D Total Body Photography (TBP) Vectra® WB360 system's utility and clinical performance in detecting melanoma in the real-world setting will be compared to the gold standard with clinical assessments by experienced dermatologists, to currently widespread used 2D imaging tools (FotoFinder ATBM® Master) and to the Smartphone-based algorithm application (e.g. SkinVision®). Here included are specific questions regarding the patients' subjective experience, acceptance and evaluation of modern technological examination. Additionally, the overall psychological burden and worry of melanoma risk or disease, anxiety, depression will be compared in different groups of patients and psychological support need and real uptake of support and its predictors will be investigated in all participants. To validate the MELVEC (Melanoma Detection in Switzerland with Vectra®) test procedure, an analysis of the measurement repeatability of computer-guided risk assessment scores for early melanoma detection will be performed. A potential benefit of this validation analysis is the optimization of study procedure for future follow-up visits and further enrolled patients in the MELVEC study. Additionally, results will shed light on the reliability of the convolutional neural networks (CNNs) investigated and help formulate recommendations for their current use. Furthermore, results will provide important data for the manufacturers regarding the systems' reliability in clinical application to help future improvement of the respective algorithms.

Conditions

• Melanoma (Skin)

Interventions

Type	Name	Description
DEVICE	3D imaging Total Body Photography Vectra® WB360	3D Total Body Photography Vectra® WB360 (Canfield Scientific, Parsippany, New Jersey, USA) and its digital dermoscopic camera (VISIOMED® D200evo dermatoscope) and scoring of pigmented skin lesions. All participants of this study will undergo 3D TBP at baseline and the follow-up visits up to month 24.
DEVICE	2D imaging FotoFinder ATBM® Master imaging system	2D imaging with FotoFinder® Mole Analyzer and scoring of pigmented skin lesions. All participants of this study will undergo 2D imaging FotoFinder ATBM® Master imaging system at baseline and the follow-up visits up to month 24.
DEVICE	Smartphone application (SkinVision®)	Smartphone application for all dermatoscopically documented pigmented skin lesions in all study participations and record of risk assessment of the health application (low, medium or high risk) to compare the app's accuracy in risk assessment with the AI tools and the dermatologist. The SkinVision® smartphone app is CE certified.of skin lesions. All participants of this study will undergo Smartphone application (SkinVision®) at baseline and the follow-up visits up to month 12.
OTHER	Standard-of-care clinical assessment of the skin	Clinical skin examination with dermatoscope by an experienced dermatologist and risk assessment of pigmented lesions (melanoma vs. naevus). All participants of this study will undergo Standard-of-care clinical assessment of the skin at baseline and the follow-up visits up to month 24.

Timeline

• Start date: 2021-01-25
• Primary completion: 2024-01-31
• Completion: 2024-01-31
• First posted: 2020-10-28
• Last updated: 2024-03-19

Locations

1 site across 1 country: Switzerland