Melanoma Image Analysis Algorithm (MIAA) Validation Study

Study Overview
=================
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.

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.

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

Conditions
-----------------
Malignant Melanoma

Intervention / Treatment
-----------------
* Device: Melanoma Image Analysis Algorithm (MIAA)


Participation Criteria
=================
Eligibility 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: All patients<br>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)<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 | 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 | 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 | Study completion, on average 2 weeks | 
| 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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. | 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 | 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, | 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 | Study completion, on average 2 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diagnosis, skin imaging