Melanoma Image Analysis Algorithm (MIAA) Validation Study

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Malignant Melanoma	Device: Melanoma Image Analysis Algorithm (MIAA)	Not Applicable

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	500 participants
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Diagnostic
Official Title:	Effectiveness of an Image Analysing Algorithm to Diagnose Melanoma Compared to Gold Standard Histological Determination
Actual Study Start Date :	January 11, 2017
Estimated Primary Completion Date :	June 30, 2018
Estimated Study Completion Date :	June 30, 2018

Arms and Interventions

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Arm	Intervention/treatment
Experimental: All patients; 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); 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.

Outcome Measures

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Primary Outcome Measures :

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 [ Time Frame: Study completion, on average 2 weeks ]
   Compare the MIAA result with the biopsy result

Secondary Outcome Measures :

1. The sensitivity of MIAA, using a MLE from all of the available images of biopsied lesions, compared to the biopsy result [ Time Frame: Study completion, on average 2 weeks ]
   %true positives, as determined by biopsy, identified
2. The sensitivity of MIAA, using a MLE from all of the available images of non-biopsied lesions, compared to clinical assessment [ Time Frame: Study completion, on average 2 weeks ]
   %true positives, as determined by clinician, identified
3. The specificity of MIAA, using a MLE from all of the available images of biopsied lesions, compared to the biopsy result [ Time Frame: Study completion, on average 2 weeks ]
   %true negatives, as determined by biopsy, identified
4. The specificity of MIAA, using a MLE from all of the available images of non-biopsied lesions, compared to clinical assessment [ Time Frame: Study completion, on average 2 weeks ]
   %true negatives, as determined by clinician, identified
5. The positive predictive value of MIAA, using a MLE from all of the available images of biopsied lesions, compared to the biopsy result [ Time Frame: Study completion, on average 2 weeks ]
   Probability that subjects with a positive MIAA result have a positive biopsy result
6. The positive predictive value of MIAA, using a MLE from all of the available images of non-biopsied lesions, compared to clinical assessment [ Time Frame: Study completion, on average 2 weeks ]
   Probability that subjects with a positive MIAA result are thought likely to have melanoma by the clinician
7. The negative predictive value of MIAA, using a MLE from all of the available images of biopsied lesions, compared to the biopsy result [ Time Frame: Study completion, on average 2 weeks ]
   Probability that subjects with a negative MIAA result have a negative biopsy result
8. The negative predictive value of MIAA, using a MLE from all of the available images of non-biopsied lesions, compared to clinical assessment [ Time Frame: Study completion, on average 2 weeks ]
   Probability that subjects with a negative MIAA result are not thought likely to have melanoma by the clinician
9. The false positive rate of MIAA, using a MLE from all of the available images of biopsied lesions, compared to the biopsy result [ Time Frame: Study completion, on average 2 weeks ]
   Probability that subject with positive MIAA result has a negative biopsy result
10. The false positive rate of MIAA, using a MLE from all of the available images of non-biopsied lesions, compared to clinical assesment [ Time Frame: Study completion, on average 2 weeks ]
    Probability that subject with positive MIAA result are not thought likely to have melanoma by the clinician
11. The false negative rate of MIAA, using a MLE from all of the available images of biopsied lesions, compared to the biopsy result [ Time Frame: Study completion, on average 2 weeks ]
    Probability that subject with negative MIAA result has a positive biopsy result
12. The false negative rate of MIAA, using a MLE from all of the available images of non-biopsied lesions, compared to clinical assessment [ Time Frame: Study completion, on average 2 weeks ]
    Probability that subject with negative MIAA result are thought likely to have melanoma by the clinician
13. The AUROC of MIAA, using images of biopsied lesions from each of the image capture apparatus combinations, compared to the biopsy result [ Time Frame: Study completion, on average 2 weeks ]
    Comparing the MIAA result, using images taken by each device, with the biopsy result
14. The AUROC of MIAA, using images of non-biopsied lesions from each of the image capture apparatus combinations, compared to clinical assessment [ Time Frame: Study completion, on average 2 weeks ]
    Comparing the MIAA result, using images taken by each device, with the clinician's diagnosis
15. The sensitivity of MIAA, using images of biopsied lesions from each of the image capture apparatus, compared to the biopsy result [ Time Frame: Study completion, on average 2 weeks ]
    %true positives, as determined by biopsy, identified by each imaging device
16. The sensitivity of MIAA, using images of non-biopsied lesions from each of the image capture apparatus, compared to clinical assessment [ Time Frame: Study completion, on average 2 weeks ]
    %true positives, as determined by clinician, identified by each imaging device
17. The specificity of MIAA, using images of biopsied lesions from each of the image capture apparatus, compared to the biopsy result [ Time Frame: Study completion, on average 2 weeks ]
    %true negatives, as determined by biopsy, identified by each imaging device
18. The specificity of MIAA, using images of non-biopsied lesions from each of the image capture apparatus, compared to clinical assessment [ Time Frame: Study completion, on average 2 weeks ]
    %true negatives, as determined by clinician, identified by each imaging device
19. The positive predictive value of MIAA, using images of biopsied lesions from each of the image capture apparatus, compared to the biopsy result [ Time Frame: Study completion, on average 2 weeks ]
    Probability that subjects with a positive MIAA result, using images taken by each device, have a positive biopsy result
20. The positive predictive value of MIAA, using images of non-biopsied lesions from each of the image capture apparatus, compared to clinical assessment [ Time Frame: Study completion, on average 2 weeks ]
    Probability that subjects with a positive MIAA result, using images taken by each device, are thought likely to have melanoma by the clinician
21. The negative predictive value of MIAA, using images of biopsied lesions from each of the image capture apparatus, compared to the biopsy result [ Time Frame: Study completion, on average 2 weeks ]
    Probability that subjects with a negative MIAA result, using images taken by each device, have a negative biopsy result
22. The negative predictive value of MIAA, using images of non-biopsied lesions from each of the image capture apparatus, compared to clinical assessment [ Time Frame: Study completion, on average 2 weeks ]
    Probability that subjects with a negative MIAA result, using images taken by each device, are not thought likely to have melanoma by the clinician
23. The false positive rate of MIAA, using images of biopsied lesions from each of the image capture apparatus, compared to the biopsy result [ Time Frame: Study completion, on average 2 weeks ]
    Probability that subject with positive MIAA result, using images taken by each device, has a negative biopsy result
24. The false positive rate of MIAA, using images of non-biopsied lesions from each of the image capture apparatus, compared to clinical assessment [ Time Frame: Study completion, on average 2 weeks ]
    Probability that subject with positive MIAA result, using images taken by each device, are not thought likely to have melanoma by the clinician
25. The false negative rate of MIAA, using images of biopsied lesions from each of the image capture apparatus, compared to the biopsy result [ Time Frame: Study completion, on average 2 weeks ]
    Probability that subject with negative MIAA result, using images taken by each device, has a positive biopsy result
26. The false negative rate of MIAA, using images of non-biopsied lesions from each of the image capture apparatus, compared to clinical assessment [ Time Frame: Study completion, on average 2 weeks ]
    Probability that subject with negative MIAA result, using images taken by each device, are thought likely to have melanoma by the clinician
27. The concordance of MIAA result between each of the image capture apparatus [ Time Frame: Study completion, on average 2 weeks ]
    The extent to which the image capture apparatus generate the same MIAA results as the other devices
28. The number of adverse events, including adverse device events and serious adverse events. [ Time Frame: Study completion, on average 2 weeks ]
    The number of adverse events, including adverse device events and serious adverse events.
29. The proportion of lesions with 4 images that can be analysed by MIAA [ Time Frame: Study completion, on average 2 weeks ]
    The proportion of lesions with 4 images that can be analysed by MIAA
30. The proportion of lesions with at least 1 readable images that can be analysed by MIAA, [ Time Frame: Study completion, on average 2 weeks ]
    The proportion of lesions with at least 1 readable images that can be analysed by MIAA,
31. The AUROC curve of the MIAA result, using MLE from all of the available images of non-biopsied PLs, compared to the clinical assessment [ Time Frame: Study completion, on average 2 weeks ]
    Compare the MIAA result with the clinicians assessment

Other Outcome Measures:

1. Impact of patient characteristics on the AUROC assessment of MIAA [ Time Frame: Study completion, on average 2 weeks ]
   A statistical model will test the whether patient characteristics, such as age, gender, and skin type, affect the overall result and if so by how much
2. Impact of the image variables on the AUROC assessment of MIAA [ Time Frame: Study completion, on average 2 weeks ]
   A statistical model will test the whether image variables, such as manufacturer and lens type, affect the overall result and if so by how much
3. Impact of the assessing clinician's level of experience on the AUROC assessment of MIAA [ Time Frame: Study completion, on average 2 weeks ]
   A statistical model will test the whether the clinicians' level of experience affect the overall result and if so by how much
4. The concordance between the referring clinician's level of confidence for biopsy and the MIAA result [ Time Frame: Study completion, on average 2 weeks ]
   The extent to which the clinician's assessment of melanoma is the same as biopsy and MIAA results

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Contacts and Locations

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Contacts

Contact: Helen C Marsden, PhD	+44 7971571995	helen@hi-ve.co.uk
Contact: Neil Daly	+44 7748 673187	neil@skinanalytics.co.uk

Locations

United Kingdom
Royal Devon and Exeter	Recruiting
Exeter, Devon, United Kingdom, EX2 5DW
Contact: Sara Best
Whipps Corss Hospital	Recruiting
Leytonstone, London, United Kingdom, E11 1NR
Contact: Ade Aboaba
Royal Stoke University Hospital	Recruiting
Stoke, Staffordshire, United Kingdom, ST4 6QG
Contact: Rochelle Rhodes
Russells Hall Hospital	Recruiting
Dudley, West Midlands, United Kingdom, DY1 2HQ
Contact: Tracy Henn
Contact: Wara Mudunge
Bristol Royal Infirmary	Recruiting
Bristol, United Kingdom, BS2 8AE
Contact: Natasha Beck
Royal Free London NHS Foundation Trust	Not yet recruiting
London, United Kingdom, NW3 2QG
Contact: Ioulios Palamaras, MD PhD 02083752585 ioulios.palamaras@nhs.net
Contact: Beatrice Yakubu
Churchill Hospital	Active, not recruiting
Oxford, United Kingdom, OX3 7LE

Sponsors and Collaborators

Skin Analytics Limited

Investigators

Principal Investigator:	Ioulios Palamaras, MD PhD	Royal Free London NHS Foundation Trust

More Information

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Responsible Party:	Skin Analytics Limited
ClinicalTrials.gov Identifier:	NCT02612168 History of Changes
Other Study ID Numbers:	SA-001-4ev
First Posted:	November 23, 2015
Last Update Posted:	May 11, 2018
Last Verified:	May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Undecided

Studies a U.S. FDA-regulated Drug Product:		No
Studies a U.S. FDA-regulated Device Product:		No

Keywords provided by Skin Analytics Limited:

Diagnosis; skin imaging

Additional relevant MeSH terms:

Melanoma; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal	Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas