Prospective, single-arm, cross-sectional, study to establish the effectiveness of MIAA to detect melanoma in pigmented lesions, compared to gold standard histological determination.
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
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
514
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.
Royal Devon and Exeter
Exeter, Devon, United Kingdom
Whipps Corss Hospital
Leytonstone, London, United Kingdom
Royal Stoke University Hospital
Stoke, Staffordshire, United Kingdom
Russells Hall Hospital
Dudley, West Midlands, United Kingdom
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
Time frame: Study completion, on average 2 weeks
The sensitivity of MIAA, using a MLE from all of the available images of biopsied lesions, compared to the biopsy result
%true positives, as determined by biopsy, identified
Time frame: 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
%true positives, as determined by clinician, identified
Time frame: 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
%true negatives, as determined by biopsy, identified
Time frame: 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
%true negatives, as determined by clinician, identified
Time frame: 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
Probability that subjects with a positive MIAA result have a positive biopsy result
Time frame: Study completion, on average 2 weeks
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Bristol Royal Infirmary
Bristol, United Kingdom
Royal Free London NHS Foundation Trust
London, United Kingdom
Churchill Hospital
Oxford, United Kingdom
The positive predictive value of MIAA, using a MLE from all of the available images of non-biopsied lesions, compared to clinical assessment
Probability that subjects with a positive MIAA result are thought likely to have melanoma by the clinician
Time frame: Study completion, on average 2 weeks
The negative predictive value of MIAA, using a MLE from all of the available images of biopsied lesions, compared to the biopsy result
Probability that subjects with a negative MIAA result have a negative biopsy result
Time frame: Study completion, on average 2 weeks
The negative predictive value of MIAA, using a MLE from all of the available images of non-biopsied lesions, compared to clinical assessment
Probability that subjects with a negative MIAA result are not thought likely to have melanoma by the clinician
Time frame: Study completion, on average 2 weeks
The false positive rate of MIAA, using a MLE from all of the available images of biopsied lesions, compared to the biopsy result
Probability that subject with positive MIAA result has a negative biopsy result
Time frame: Study completion, on average 2 weeks
The false positive rate of MIAA, using a MLE from all of the available images of non-biopsied lesions, compared to clinical assesment
Probability that subject with positive MIAA result are not thought likely to have melanoma by the clinician
Time frame: Study completion, on average 2 weeks
The false negative rate of MIAA, using a MLE from all of the available images of biopsied lesions, compared to the biopsy result
Probability that subject with negative MIAA result has a positive biopsy result
Time frame: Study completion, on average 2 weeks
The false negative rate of MIAA, using a MLE from all of the available images of non-biopsied lesions, compared to clinical assessment
Probability that subject with negative MIAA result are thought likely to have melanoma by the clinician
Time frame: Study completion, on average 2 weeks
The AUROC of MIAA, using images of biopsied lesions from each of the image capture apparatus combinations, compared to the biopsy result
Comparing the MIAA result, using images taken by each device, with the biopsy result
Time frame: Study completion, on average 2 weeks
The AUROC of MIAA, using images of non-biopsied lesions from each of the image capture apparatus combinations, compared to clinical assessment
Comparing the MIAA result, using images taken by each device, with the clinician's diagnosis
Time frame: Study completion, on average 2 weeks
The sensitivity of MIAA, using images of biopsied lesions from each of the image capture apparatus, compared to the biopsy result
%true positives, as determined by biopsy, identified by each imaging device
Time frame: Study completion, on average 2 weeks
The sensitivity of MIAA, using images of non-biopsied lesions from each of the image capture apparatus, compared to clinical assessment
%true positives, as determined by clinician, identified by each imaging device
Time frame: Study completion, on average 2 weeks
The specificity of MIAA, using images of biopsied lesions from each of the image capture apparatus, compared to the biopsy result
%true negatives, as determined by biopsy, identified by each imaging device
Time frame: Study completion, on average 2 weeks
The specificity of MIAA, using images of non-biopsied lesions from each of the image capture apparatus, compared to clinical assessment
%true negatives, as determined by clinician, identified by each imaging device
Time frame: Study completion, on average 2 weeks
The positive predictive value of MIAA, using images of biopsied lesions from each of the image capture apparatus, compared to the biopsy result
Probability that subjects with a positive MIAA result, using images taken by each device, have a positive biopsy result
Time frame: Study completion, on average 2 weeks
The positive predictive value of MIAA, using images of non-biopsied lesions from each of the image capture apparatus, compared to clinical assessment
Probability that subjects with a positive MIAA result, using images taken by each device, are thought likely to have melanoma by the clinician
Time frame: Study completion, on average 2 weeks
The negative predictive value of MIAA, using images of biopsied lesions from each of the image capture apparatus, compared to the biopsy result
Probability that subjects with a negative MIAA result, using images taken by each device, have a negative biopsy result
Time frame: Study completion, on average 2 weeks
The negative predictive value of MIAA, using images of non-biopsied lesions from each of the image capture apparatus, compared to clinical assessment
Probability that subjects with a negative MIAA result, using images taken by each device, are not thought likely to have melanoma by the clinician
Time frame: Study completion, on average 2 weeks
The false positive rate of MIAA, using images of biopsied lesions from each of the image capture apparatus, compared to the biopsy result
Probability that subject with positive MIAA result, using images taken by each device, has a negative biopsy result
Time frame: Study completion, on average 2 weeks
The false positive rate of MIAA, using images of non-biopsied lesions from each of the image capture apparatus, compared to clinical assessment
Probability that subject with positive MIAA result, using images taken by each device, are not thought likely to have melanoma by the clinician
Time frame: Study completion, on average 2 weeks
The false negative rate of MIAA, using images of biopsied lesions from each of the image capture apparatus, compared to the biopsy result
Probability that subject with negative MIAA result, using images taken by each device, has a positive biopsy result
Time frame: Study completion, on average 2 weeks
The false negative rate of MIAA, using images of non-biopsied lesions from each of the image capture apparatus, compared to clinical assessment
Probability that subject with negative MIAA result, using images taken by each device, are thought likely to have melanoma by the clinician
Time frame: Study completion, on average 2 weeks
The concordance of MIAA result between each of the image capture apparatus
The extent to which the image capture apparatus generate the same MIAA results as the other devices
Time frame: Study completion, on average 2 weeks
The number of adverse events, including adverse device events and serious adverse events.
The number of adverse events, including adverse device events and serious adverse events.
Time frame: Study completion, on average 2 weeks
The proportion of lesions with 4 images that can be analysed by MIAA
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 at least 1 readable images that can be analysed by MIAA,
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 AUROC curve of the MIAA result, using MLE from all of the available images of non-biopsied PLs, compared to the clinical assessment
Compare the MIAA result with the clinicians assessment
Time frame: Study completion, on average 2 weeks