Melanoma Image Analysis Algorithm (MIAA) Validation Study

NCT02612168 | Completed

• 1 other identifier: SA-001-4ev
• Study Type: interventional
• Target: 514
• Locations: 1 country
• Sites: 7

Brief 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.

Conditions

Malignant Melanoma

Keywords

Diagnosis; skin imaging

Outcome Measures

Primary Outcomes (1)

• The Area Under the Curve of a Receiver Operating Characteristic (AUROC) curve of MIAA result, using a maximum likelihood estimation (MLE) from all of the available images of biopsied lesions, compared to the biopsy result

  Compare the MIAA result with the biopsy result

  Study completion, on average 2 weeks

Secondary Outcomes (31)

• The sensitivity of MIAA, using a MLE from all of the available images of biopsied lesions, compared to the biopsy result

  Study completion, on average 2 weeks

• The sensitivity of MIAA, using a MLE from all of the available images of non-biopsied lesions, compared to clinical assessment

  Study completion, on average 2 weeks

• The specificity of MIAA, using a MLE from all of the available images of biopsied lesions, compared to the biopsy result

  Study completion, on average 2 weeks

• The specificity of MIAA, using a MLE from all of the available images of non-biopsied lesions, compared to clinical assessment

  Study completion, on average 2 weeks

• The positive predictive value of MIAA, using a MLE from all of the available images of biopsied lesions, compared to the biopsy result

  Study completion, on average 2 weeks

Other Outcomes (4)

• Impact of patient characteristics on the AUROC assessment of MIAA

  Study completion, on average 2 weeks

• Impact of the image variables on the AUROC assessment of MIAA

  Study completion, on average 2 weeks

• Impact of the assessing clinician's level of experience on the AUROC assessment of MIAA

  Study completion, on average 2 weeks

Study Arms (1)

All patients

EXPERIMENTAL

Each patient will have any pigmented lesions (PLs) which are due to be biopsied, two PLs not due for biopsy and one patch of healthy skin photographed. Each will be photographed using three cameras: A standard DSLR and two smartphones with a dermoscopic lens attachment. Photographic images will be analysed by Melanoma Image Analysis Algorithm (MIAA)

Device: Melanoma Image Analysis Algorithm (MIAA)

Interventions

Melanoma Image Analysis Algorithm (MIAA) DEVICE

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.

All patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant is willing and able to give informed consent for participation in the study,
• Male or Female, aged 18 years or above,
• Have at least 1 lesion suitable for photographing that is scheduled for biopsy to determine the presence of melanoma,
• In the Investigators opinion, able and willing to comply with all study requirements.

You may not qualify if:

• Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study.

Sponsors & Collaborators

• Skin Analytics Limited: lead

Study Sites (7)

Royal Devon and Exeter

Exeter, Devon, EX2 5DW, United Kingdom

Location

Whipps Corss Hospital

Leytonstone, London, E11 1NR, United Kingdom

Location

Royal Stoke University Hospital

Stoke, Staffordshire, ST4 6QG, United Kingdom

Location

Russells Hall Hospital

Dudley, West Midlands, DY1 2HQ, United Kingdom

Location

Bristol Royal Infirmary

Bristol, BS2 8AE, United Kingdom

Location

Royal Free London NHS Foundation Trust

London, NW3 2QG, United Kingdom

Location

Churchill Hospital

Oxford, OX3 7LE, United Kingdom

Location

MeSH Terms

Conditions

Melanoma; Disease

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ioulios Palamaras, MD PhD

  Royal Free London NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: November 18, 2015
• First Posted: November 23, 2015
• Study Start: January 11, 2017
• Primary Completion: July 11, 2018
• Study Completion: July 11, 2018
• Last Updated: January 25, 2019

Record last verified: 2019-01

Locations

GB (7)