NCT02612168

Melanoma Image Analysis Algorithm (MIAA) Validation Study

Effectiveness of an Image Analysing Algorithm to Diagnose Melanoma Compared to Gold Standard Histological Determination

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 514 (actual)
• Sponsor: Skin Analytics Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Prospective, single-arm, cross-sectional, study to establish the effectiveness of MIAA to detect melanoma in pigmented lesions, compared to gold standard histological determination.

Detailed description

Skin Analytics Limited have developed an algorithm (MIAA) which reviews photographs of pigmented lesions to determine whether melanoma is likely to be present. This study aims to establish how well MIAA determines the presence or absence of melanoma, compared to a biopsy. Pigmented lesions that a dermatologist has decided to biopsy, and are suitable for photographing, will be photographed up to five times in a single visit. Three different camera will be used, and two different dermoscopic lens attachments will be used on smartphone cameras. Images will be analysed by MIAA and the results compared to the biopsy result. Clinicians, patients and the statistical analysis team will be blinded to the result of MIAA. At least 65 pigmented lesions positive for melanoma (as determined by biopsy) are required, which is predicted to mean 1250 patients will be recruited.

Conditions

• Malignant Melanoma

Interventions

Type	Name	Description
DEVICE	Melanoma Image Analysis Algorithm (MIAA)	The images will be analysed by MIAA (Melanoma Image Analysis Algorithm). The MIAA result for PLs that are biopsied will be compared to the diagnosis made from the biopsy. The MIAA result for PLs not biopsied will be compared to clinician diagnosis.

Timeline

• Start date: 2017-01-11
• Primary completion: 2018-07-11
• Completion: 2018-07-11
• First posted: 2015-11-23
• Last updated: 2019-01-25

Locations

7 sites across 1 country: United Kingdom