Malignant MelanomaNCT02612168
Melanoma Image Analysis Algorithm (MIAA) Validation Study
A study testing Melanoma Image Analysis Algorithm (MIAA) in people with Malignant Melanoma, run by Skin Analytics Limited at 7 sites in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Melanoma
- What is being tested?
- Melanoma Image Analysis Algorithm (MIAA)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 514 participants
- Where
- 7 sitesUnited Kingdom
- Study dates
- 11 Jan 2017to 11 Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United Kingdom7 sites
Bristol Royal Infirmary
Bristol, BS2 8AE
Russells Hall Hospital
Dudley, West Midlands, DY1 2HQ
Royal Devon and Exeter
Exeter, Devon, EX2 5DW
Whipps Corss Hospital
Leytonstone, London, E11 1NR
Royal Free London NHS Foundation Trust
London, NW3 2QG
Churchill Hospital
Oxford, OX3 7LE
Royal Stoke University Hospital
Stoke, Staffordshire, ST4 6QG
About this study
Official title: Effectiveness of an Image Analysing Algorithm to Diagnose Melanoma Compared to Gold Standard Histological Determination
Prospective, single-arm, cross-sectional, study to establish the effectiveness of MIAA to detect melanoma in pigmented lesions, compared to gold standard histological determination.
Read the 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.
- Conditions
- Malignant Melanoma
- Being tested
- Melanoma Image Analysis Algorithm (MIAA)
- Keywords
- Diagnosis, skin imaging
- Medical subject headings
- Melanoma, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Melanoma Image Analysis Algorithm (MIAA)Device
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.
| Study group | Role | What they receive |
|---|---|---|
| All patients | Experimental | 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) Receives: Device: Melanoma Image Analysis Algorithm (MIAA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Study completion, on average 2 weeks
Secondary outcomes (31)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: 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,
Measured: 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
Measured: Study completion, on average 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2015 (estimated)
- Study start11 Jan 2017
- Primary completion11 Jul 2018
- Study completion11 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant MelanomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 514 participants (actual)
Sponsor and investigators
- Lead sponsor
- Skin Analytics Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ioulios Palamaras, MD PhD, Principal investigator, Royal Free London NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02612168
- Sponsor's protocol ID
- SA-001-4ev
- Status last verified
- Jan 2019
- First submitted
- 18 Nov 2015
- Last updated
- 25 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of an Image Analysing Algorithm to Diagnose Melanoma Compared to Gold Standard Histological Determination
- ClinicalTrials.gov ID
- NCT02612168
- Acronym / sponsor ID
- SA-001-4ev
- Conditions
- Malignant Melanoma
- Keywords
- Diagnosis, skin imaging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 514 participants (actual)
- Lead sponsor
- Skin Analytics LimitedIndustry (pharma, biotech, devices)
- Study start
- 11 Jan 2017 (actual)
- Primary completion
- 11 Jul 2018 (actual)
- Study completion
- 11 Jul 2018 (actual)
- First posted
- 23 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All patients | Experimental | Device: Melanoma Image Analysis Algorithm (MIAA)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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | All patients |
Primary outcome
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
Time frame: Study completion, on average 2 weeks
Compare the MIAA result with the biopsy result
31 secondary outcomes
The sensitivity of MIAA, using a MLE from all of the available images of biopsied lesions, compared to 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 non-biopsied lesions, compared to clinical assessment
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
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
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
Time frame: 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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Time frame: Study completion, on average 2 weeks
The concordance of MIAA result between each of the image capture apparatus
Time frame: Study completion, on average 2 weeks
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
Time frame: Study completion, on average 2 weeks
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
Time frame: Study completion, on average 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ioulios Palamaras, MD PhD principal investigator
Royal Free London NHS Foundation Trust
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Melanoma Image Analysis Algorithm (MIAA) in people with Malignant Melanoma, run by Skin Analytics Limited at 7 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: Study completion, on average 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2019.