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Trial record 14 of 2393 for:    melanoma

Melanoma Image Analysis Algorithm (MIAA) Validation Study

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ClinicalTrials.gov Identifier: NCT02612168
Recruitment Status : Recruiting
First Posted : November 23, 2015
Last Update Posted : October 4, 2017
Sponsor:
Information provided by (Responsible Party):
Skin Analytics Limited

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1250 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 1, 2018
Estimated Study Completion Date : June 14, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma
U.S. FDA Resources

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.



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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02612168


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: Rob James         
Royal Stoke University Hospital Recruiting
Stoke, Staffordshire, United Kingdom, ST4 6QG
Contact: Amanda Hall         
Contact: Emma Sadler         
Royal Free London NHS Foundation Trust Not yet recruiting
London, United Kingdom, NW3 2QG
Contact: Ioulios Palamaras, MD PhD    02083752585    ioulios.palamaras@nhs.net   
Sponsors and Collaborators
Skin Analytics Limited
Investigators
Principal Investigator: Ioulios Palamaras, MD PhD Royal Free London NHS Foundation Trust

Responsible Party: Skin Analytics Limited
ClinicalTrials.gov Identifier: NCT02612168     History of Changes
Other Study ID Numbers: SA-001-4ev
First Posted: November 23, 2015    Key Record Dates
Last Update Posted: October 4, 2017
Last Verified: April 2017
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