Malignant Melanoma
Conditions
Keywords
Diagnosis, skin imaging
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.
Interventions
DEVICEMelanoma 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.
Sponsors
Skin Analytics Limited
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Study completion, on average 2 weeks | Compare the MIAA result with the biopsy result |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The sensitivity of MIAA, using images of biopsied lesions from each of the image capture apparatus, compared to the biopsy result | Study completion, on average 2 weeks | %true positives, as determined by biopsy, identified by each imaging device |
| The number of adverse events, including adverse device events and serious adverse events. | Study completion, on average 2 weeks | The number of adverse events, including adverse device events and serious adverse events. |
| The proportion of lesions with 4 images that can be analysed by MIAA | Study completion, on average 2 weeks | The proportion of lesions with 4 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 proportion of lesions with at least 1 readable images that can be analysed by MIAA, |
| The AUROC curve of the MIAA result, using MLE from all of the available images of non-biopsied PLs, compared to the clinical assessment | Study completion, on average 2 weeks | Compare the MIAA result with the clinicians assessment |
| The sensitivity of MIAA, using a MLE from all of the available images of biopsied lesions, compared to the biopsy result | Study completion, on average 2 weeks | %true positives, as determined by biopsy, identified |
| The sensitivity of MIAA, using a MLE from all of the available images of non-biopsied lesions, compared to clinical assessment | Study completion, on average 2 weeks | %true positives, as determined by clinician, identified |
| The specificity of MIAA, using a MLE from all of the available images of biopsied lesions, compared to the biopsy result | Study completion, on average 2 weeks | %true negatives, as determined by biopsy, identified |
| The specificity of MIAA, using a MLE from all of the available images of non-biopsied lesions, compared to clinical assessment | Study completion, on average 2 weeks | %true negatives, as determined by clinician, identified |
| The positive predictive value of MIAA, using a MLE from all of the available images of biopsied lesions, compared to the biopsy result | Study completion, on average 2 weeks | Probability that subjects with a positive MIAA result have a positive biopsy result |
| The positive predictive value of MIAA, using a MLE from all of the available images of non-biopsied lesions, compared to clinical assessment | Study completion, on average 2 weeks | Probability that subjects with a positive MIAA result are thought likely to have melanoma by the clinician |
| The negative predictive value of MIAA, using a MLE from all of the available images of biopsied lesions, compared to the biopsy result | Study completion, on average 2 weeks | Probability that subjects with a negative MIAA result have a negative biopsy result |
| The negative predictive value of MIAA, using a MLE from all of the available images of non-biopsied lesions, compared to clinical assessment | Study completion, on average 2 weeks | Probability that subjects with a negative MIAA result are not thought likely to have melanoma by the clinician |
| The false positive rate of MIAA, using a MLE from all of the available images of biopsied lesions, compared to the biopsy result | Study completion, on average 2 weeks | Probability that subject with positive MIAA result has a negative biopsy result |
| The false positive rate of MIAA, using a MLE from all of the available images of non-biopsied lesions, compared to clinical assesment | Study completion, on average 2 weeks | Probability that subject with positive MIAA result are not thought likely to have melanoma by the clinician |
| The false negative rate of MIAA, using a MLE from all of the available images of biopsied lesions, compared to the biopsy result | Study completion, on average 2 weeks | Probability that subject with negative MIAA result has a positive biopsy result |
| The false negative rate of MIAA, using a MLE from all of the available images of non-biopsied lesions, compared to clinical assessment | Study completion, on average 2 weeks | Probability that subject with negative MIAA result are thought likely to have melanoma by the clinician |
| The AUROC of MIAA, using images of biopsied lesions from each of the image capture apparatus combinations, compared to the biopsy result | Study completion, on average 2 weeks | Comparing the MIAA result, using images taken by each device, with the biopsy result |
| The AUROC of MIAA, using images of non-biopsied lesions from each of the image capture apparatus combinations, compared to clinical assessment | Study completion, on average 2 weeks | Comparing the MIAA result, using images taken by each device, with the clinician's diagnosis |
| The sensitivity of MIAA, using images of non-biopsied lesions from each of the image capture apparatus, compared to clinical assessment | Study completion, on average 2 weeks | %true positives, as determined by clinician, identified by each imaging device |
| The specificity of MIAA, using images of biopsied lesions from each of the image capture apparatus, compared to the biopsy result | Study completion, on average 2 weeks | %true negatives, as determined by biopsy, identified by each imaging device |
| The specificity of MIAA, using images of non-biopsied lesions from each of the image capture apparatus, compared to clinical assessment | Study completion, on average 2 weeks | %true negatives, as determined by clinician, identified by each imaging device |
| The positive predictive value of MIAA, using images of biopsied lesions from each of the image capture apparatus, compared to the biopsy result | 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 |
| The positive predictive value of MIAA, using images of non-biopsied lesions from each of the image capture apparatus, compared to clinical assessment | 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 |
| The negative predictive value of MIAA, using images of biopsied lesions from each of the image capture apparatus, compared to the biopsy result | 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 |
| The negative predictive value of MIAA, using images of non-biopsied lesions from each of the image capture apparatus, compared to clinical assessment | 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 |
| The false positive rate of MIAA, using images of biopsied lesions from each of the image capture apparatus, compared to the biopsy result | Study completion, on average 2 weeks | Probability that subject with positive MIAA result, using images taken by each device, has a negative biopsy result |
| The false positive rate of MIAA, using images of non-biopsied lesions from each of the image capture apparatus, compared to clinical assessment | 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 |
| The false negative rate of MIAA, using images of biopsied lesions from each of the image capture apparatus, compared to the biopsy result | Study completion, on average 2 weeks | Probability that subject with negative MIAA result, using images taken by each device, has a positive biopsy result |
| The false negative rate of MIAA, using images of non-biopsied lesions from each of the image capture apparatus, compared to clinical assessment | 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 |
| The concordance of MIAA result between each of the image capture apparatus | Study completion, on average 2 weeks | The extent to which the image capture apparatus generate the same MIAA results as the other devices |
Other
| Measure | Time frame | Description |
|---|---|---|
| Impact of the assessing clinician's level of experience on the AUROC assessment of MIAA | 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 |
| The concordance between the referring clinician's level of confidence for biopsy and the MIAA result | Study completion, on average 2 weeks | The extent to which the clinician's assessment of melanoma is the same as biopsy and MIAA results |
| Impact of patient characteristics on the AUROC assessment of MIAA | 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 |
| Impact of the image variables on the AUROC assessment of MIAA | 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 |
Countries
United Kingdom
Outcome results
None listed