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Completed

NCT Number: NCT02612168

Melanoma Image Analysis Algorithm (MIAA) Validation Study

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

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Royal Devon and Exeter, Exeter, Devon, United Kingdom

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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

    Time frame: Study completion, on average 2 weeks

    Compare the MIAA result with the biopsy result

Secondary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Skin Analytics Limited

Industry

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Nov 23, 2015
Registry last updated
Jan 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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