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Melanoma Image Analysis Algorithm (MIAA) Validation Study

Primary Purpose

Malignant Melanoma

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Melanoma Image Analysis Algorithm (MIAA)
Sponsored by
Skin Analytics Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Malignant Melanoma focused on measuring Diagnosis, skin imaging

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Royal Devon and Exeter
  • Whipps Corss Hospital
  • Royal Stoke University Hospital
  • Russells Hall Hospital
  • Bristol Royal Infirmary
  • Royal Free London NHS Foundation Trust
  • Churchill Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

All patients

Arm Description

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)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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.
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
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,
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

Full Information

First Posted
November 18, 2015
Last Updated
January 24, 2019
Sponsor
Skin Analytics Limited
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1. Study Identification

Unique Protocol Identification Number
NCT02612168
Brief Title
Melanoma Image Analysis Algorithm (MIAA) Validation Study
Official Title
Effectiveness of an Image Analysing Algorithm to Diagnose Melanoma Compared to Gold Standard Histological Determination
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
January 11, 2017 (Actual)
Primary Completion Date
July 11, 2018 (Actual)
Study Completion Date
July 11, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Skin Analytics Limited

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malignant Melanoma
Keywords
Diagnosis, skin imaging

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
514 (Actual)

8. Arms, Groups, and Interventions

Arm Title
All patients
Arm Type
Experimental
Arm Description
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)
Intervention Type
Device
Intervention Name(s)
Melanoma Image Analysis Algorithm (MIAA)
Intervention Description
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 Measure Information:
Title
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
Description
Compare the MIAA result with the biopsy result
Time Frame
Study completion, on average 2 weeks
Secondary Outcome Measure Information:
Title
The sensitivity of MIAA, using a MLE from all of the available images of biopsied lesions, compared to the biopsy result
Description
%true positives, as determined by biopsy, identified
Time Frame
Study completion, on average 2 weeks
Title
The sensitivity of MIAA, using a MLE from all of the available images of non-biopsied lesions, compared to clinical assessment
Description
%true positives, as determined by clinician, identified
Time Frame
Study completion, on average 2 weeks
Title
The specificity of MIAA, using a MLE from all of the available images of biopsied lesions, compared to the biopsy result
Description
%true negatives, as determined by biopsy, identified
Time Frame
Study completion, on average 2 weeks
Title
The specificity of MIAA, using a MLE from all of the available images of non-biopsied lesions, compared to clinical assessment
Description
%true negatives, as determined by clinician, identified
Time Frame
Study completion, on average 2 weeks
Title
The positive predictive value of MIAA, using a MLE from all of the available images of biopsied lesions, compared to the biopsy result
Description
Probability that subjects with a positive MIAA result have a positive biopsy result
Time Frame
Study completion, on average 2 weeks
Title
The positive predictive value of MIAA, using a MLE from all of the available images of non-biopsied lesions, compared to clinical assessment
Description
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
Title
The negative predictive value of MIAA, using a MLE from all of the available images of biopsied lesions, compared to the biopsy result
Description
Probability that subjects with a negative MIAA result have a negative biopsy result
Time Frame
Study completion, on average 2 weeks
Title
The negative predictive value of MIAA, using a MLE from all of the available images of non-biopsied lesions, compared to clinical assessment
Description
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
Title
The false positive rate of MIAA, using a MLE from all of the available images of biopsied lesions, compared to the biopsy result
Description
Probability that subject with positive MIAA result has a negative biopsy result
Time Frame
Study completion, on average 2 weeks
Title
The false positive rate of MIAA, using a MLE from all of the available images of non-biopsied lesions, compared to clinical assesment
Description
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
Title
The false negative rate of MIAA, using a MLE from all of the available images of biopsied lesions, compared to the biopsy result
Description
Probability that subject with negative MIAA result has a positive biopsy result
Time Frame
Study completion, on average 2 weeks
Title
The false negative rate of MIAA, using a MLE from all of the available images of non-biopsied lesions, compared to clinical assessment
Description
Probability that subject with negative MIAA result are thought likely to have melanoma by the clinician
Time Frame
Study completion, on average 2 weeks
Title
The AUROC of MIAA, using images of biopsied lesions from each of the image capture apparatus combinations, compared to the biopsy result
Description
Comparing the MIAA result, using images taken by each device, with the biopsy result
Time Frame
Study completion, on average 2 weeks
Title
The AUROC of MIAA, using images of non-biopsied lesions from each of the image capture apparatus combinations, compared to clinical assessment
Description
Comparing the MIAA result, using images taken by each device, with the clinician's diagnosis
Time Frame
Study completion, on average 2 weeks
Title
The sensitivity of MIAA, using images of biopsied lesions from each of the image capture apparatus, compared to the biopsy result
Description
%true positives, as determined by biopsy, identified by each imaging device
Time Frame
Study completion, on average 2 weeks
Title
The sensitivity of MIAA, using images of non-biopsied lesions from each of the image capture apparatus, compared to clinical assessment
Description
%true positives, as determined by clinician, identified by each imaging device
Time Frame
Study completion, on average 2 weeks
Title
The specificity of MIAA, using images of biopsied lesions from each of the image capture apparatus, compared to the biopsy result
Description
%true negatives, as determined by biopsy, identified by each imaging device
Time Frame
Study completion, on average 2 weeks
Title
The specificity of MIAA, using images of non-biopsied lesions from each of the image capture apparatus, compared to clinical assessment
Description
%true negatives, as determined by clinician, identified by each imaging device
Time Frame
Study completion, on average 2 weeks
Title
The positive predictive value of MIAA, using images of biopsied lesions from each of the image capture apparatus, compared to the biopsy result
Description
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
Title
The positive predictive value of MIAA, using images of non-biopsied lesions from each of the image capture apparatus, compared to clinical assessment
Description
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
Title
The negative predictive value of MIAA, using images of biopsied lesions from each of the image capture apparatus, compared to the biopsy result
Description
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
Title
The negative predictive value of MIAA, using images of non-biopsied lesions from each of the image capture apparatus, compared to clinical assessment
Description
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
Title
The false positive rate of MIAA, using images of biopsied lesions from each of the image capture apparatus, compared to the biopsy result
Description
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
Title
The false positive rate of MIAA, using images of non-biopsied lesions from each of the image capture apparatus, compared to clinical assessment
Description
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
Title
The false negative rate of MIAA, using images of biopsied lesions from each of the image capture apparatus, compared to the biopsy result
Description
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
Title
The false negative rate of MIAA, using images of non-biopsied lesions from each of the image capture apparatus, compared to clinical assessment
Description
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
Title
The concordance of MIAA result between each of the image capture apparatus
Description
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
Title
The number of adverse events, including adverse device events and serious adverse events.
Description
The number of adverse events, including adverse device events and serious adverse events.
Time Frame
Study completion, on average 2 weeks
Title
The proportion of lesions with 4 images that can be analysed by MIAA
Description
The proportion of lesions with 4 images that can be analysed by MIAA
Time Frame
Study completion, on average 2 weeks
Title
The proportion of lesions with at least 1 readable images that can be analysed by MIAA,
Description
The proportion of lesions with at least 1 readable images that can be analysed by MIAA,
Time Frame
Study completion, on average 2 weeks
Title
The AUROC curve of the MIAA result, using MLE from all of the available images of non-biopsied PLs, compared to the clinical assessment
Description
Compare the MIAA result with the clinicians assessment
Time Frame
Study completion, on average 2 weeks
Other Pre-specified Outcome Measures:
Title
Impact of patient characteristics on the AUROC assessment of MIAA
Description
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
Time Frame
Study completion, on average 2 weeks
Title
Impact of the image variables on the AUROC assessment of MIAA
Description
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
Time Frame
Study completion, on average 2 weeks
Title
Impact of the assessing clinician's level of experience on the AUROC assessment of MIAA
Description
A statistical model will test the whether the clinicians' level of experience affect the overall result and if so by how much
Time Frame
Study completion, on average 2 weeks
Title
The concordance between the referring clinician's level of confidence for biopsy and the MIAA result
Description
The extent to which the clinician's assessment of melanoma is the same as biopsy and MIAA results
Time Frame
Study completion, on average 2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ioulios Palamaras, MD PhD
Organizational Affiliation
Royal Free London NHS Foundation Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal Devon and Exeter
City
Exeter
State/Province
Devon
ZIP/Postal Code
EX2 5DW
Country
United Kingdom
Facility Name
Whipps Corss Hospital
City
Leytonstone
State/Province
London
ZIP/Postal Code
E11 1NR
Country
United Kingdom
Facility Name
Royal Stoke University Hospital
City
Stoke
State/Province
Staffordshire
ZIP/Postal Code
ST4 6QG
Country
United Kingdom
Facility Name
Russells Hall Hospital
City
Dudley
State/Province
West Midlands
ZIP/Postal Code
DY1 2HQ
Country
United Kingdom
Facility Name
Bristol Royal Infirmary
City
Bristol
ZIP/Postal Code
BS2 8AE
Country
United Kingdom
Facility Name
Royal Free London NHS Foundation Trust
City
London
ZIP/Postal Code
NW3 2QG
Country
United Kingdom
Facility Name
Churchill Hospital
City
Oxford
ZIP/Postal Code
OX3 7LE
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Melanoma Image Analysis Algorithm (MIAA) Validation Study

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