Melanoma Image Analysis Algorithm (MIAA) Validation Study

Malignant Melanoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02612168
• Other study ID #: SA-001-4ev
• Status: Completed
• Phase: N/A
• Start date: January 11, 2017
• Est. completion date: July 11, 2018

Study information

• Verified date: January 2019
• Source: Skin Analytics Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 514
• Est. completion date: July 11, 2018
• Est. primary completion date: July 11, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Malignant Melanoma
• Melanoma

Intervention

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.

Locations

Country	Name	City	State
United Kingdom	Bristol Royal Infirmary	Bristol
United Kingdom	Russells Hall Hospital	Dudley	West Midlands
United Kingdom	Royal Devon and Exeter	Exeter	Devon
United Kingdom	Whipps Corss Hospital	Leytonstone	London
United Kingdom	Royal Free London NHS Foundation Trust	London
United Kingdom	Churchill Hospital	Oxford
United Kingdom	Royal Stoke University Hospital	Stoke	Staffordshire

Sponsors (1)

Lead Sponsor	Collaborator
Skin Analytics Limited

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Impact of patient characteristics on the AUROC assessment of MIAA	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	Study completion, on average 2 weeks
Other	Impact of the image variables on the AUROC assessment of MIAA	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	Study completion, on average 2 weeks
Other	Impact of the assessing clinician's level of experience on the AUROC assessment of MIAA	A statistical model will test the whether the clinicians' level of experience affect the overall result and if so by how much	Study completion, on average 2 weeks
Other	The concordance between the referring clinician's level of confidence for biopsy and the MIAA result	The extent to which the clinician's assessment of melanoma is the same as biopsy and MIAA results	Study completion, on average 2 weeks
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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