Clinical trial NCT02612168: 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
Overall status: COMPLETED
Phase: NA
Conditions: Malignant Melanoma
Keywords: Diagnosis
skin imaging
Lead sponsor: Skin Analytics Limited
Sponsor class: INDUSTRY
First posted: 2015-11-23
Enrollment: 514
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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.

Primary outcomes:
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
timeFrame: Study completion, on average 2 weeks
Secondary outcomes:
measure: The sensitivity of MIAA, using a MLE from all of the available images of biopsied lesions, compared to the biopsy result
timeFrame: Study completion, on average 2 weeks
measure: The sensitivity of MIAA, using a MLE from all of the available images of non-biopsied lesions, compared to clinical assessment
timeFrame: Study completion, on average 2 weeks
measure: The specificity of MIAA, using a MLE from all of the available images of biopsied lesions, compared to the biopsy result
timeFrame: Study completion, on average 2 weeks
measure: The specificity of MIAA, using a MLE from all of the available images of non-biopsied lesions, compared to clinical assessment
timeFrame: Study completion, on average 2 weeks
measure: The positive predictive value of MIAA, using a MLE from all of the available images of biopsied lesions, compared to the biopsy result
timeFrame: Study completion, on average 2 weeks
measure: The positive predictive value of MIAA, using a MLE from all of the available images of non-biopsied lesions, compared to clinical assessment
timeFrame: Study completion, on average 2 weeks
measure: The negative predictive value of MIAA, using a MLE from all of the available images of biopsied lesions, compared to the biopsy result
timeFrame: Study completion, on average 2 weeks
measure: The negative predictive value of MIAA, using a MLE from all of the available images of non-biopsied lesions, compared to clinical assessment
timeFrame: Study completion, on average 2 weeks
measure: The false positive rate of MIAA, using a MLE from all of the available images of biopsied lesions, compared to the biopsy result
timeFrame: Study completion, on average 2 weeks
measure: The false positive rate of MIAA, using a MLE from all of the available images of non-biopsied lesions, compared to clinical assesment
timeFrame: Study completion, on average 2 weeks
measure: The false negative rate of MIAA, using a MLE from all of the available images of biopsied lesions, compared to the biopsy result
timeFrame: Study completion, on average 2 weeks
measure: The false negative rate of MIAA, using a MLE from all of the available images of non-biopsied lesions, compared to clinical assessment
timeFrame: Study completion, on average 2 weeks
measure: The AUROC of MIAA, using images of biopsied lesions from each of the image capture apparatus combinations, compared to the biopsy result
timeFrame: Study completion, on average 2 weeks
measure: The AUROC of MIAA, using images of non-biopsied lesions from each of the image capture apparatus combinations, compared to clinical assessment
timeFrame: Study completion, on average 2 weeks
measure: The sensitivity of MIAA, using images of biopsied lesions from each of the image capture apparatus, compared to the biopsy result
timeFrame: Study completion, on average 2 weeks
measure: The sensitivity of MIAA, using images of non-biopsied lesions from each of the image capture apparatus, compared to clinical assessment
timeFrame: Study completion, on average 2 weeks
measure: The specificity of MIAA, using images of biopsied lesions from each of the image capture apparatus, compared to the biopsy result
timeFrame: Study completion, on average 2 weeks
measure: The specificity of MIAA, using images of non-biopsied lesions from each of the image capture apparatus, compared to clinical assessment
timeFrame: Study completion, on average 2 weeks
measure: The positive predictive value of MIAA, using images of biopsied lesions from each of the image capture apparatus, compared to the biopsy result
timeFrame: Study completion, on average 2 weeks
measure: The positive predictive value of MIAA, using images of non-biopsied lesions from each of the image capture apparatus, compared to clinical assessment
timeFrame: Study completion, on average 2 weeks
measure: The negative predictive value of MIAA, using images of biopsied lesions from each of the image capture apparatus, compared to the biopsy result
timeFrame: Study completion, on average 2 weeks
measure: The negative predictive value of MIAA, using images of non-biopsied lesions from each of the image capture apparatus, compared to clinical assessment
timeFrame: Study completion, on average 2 weeks
measure: The false positive rate of MIAA, using images of biopsied lesions from each of the image capture apparatus, compared to the biopsy result
timeFrame: Study completion, on average 2 weeks
measure: The false positive rate of MIAA, using images of non-biopsied lesions from each of the image capture apparatus, compared to clinical assessment
timeFrame: Study completion, on average 2 weeks
measure: The false negative rate of MIAA, using images of biopsied lesions from each of the image capture apparatus, compared to the biopsy result
timeFrame: Study completion, on average 2 weeks
measure: The false negative rate of MIAA, using images of non-biopsied lesions from each of the image capture apparatus, compared to clinical assessment
timeFrame: Study completion, on average 2 weeks
measure: The concordance of MIAA result between each of the image capture apparatus
timeFrame: Study completion, on average 2 weeks
measure: The number of adverse events, including adverse device events and serious adverse events.
timeFrame: Study completion, on average 2 weeks
measure: The proportion of lesions with 4 images that can be analysed by MIAA
timeFrame: Study completion, on average 2 weeks
measure: The proportion of lesions with at least 1 readable images that can be analysed by MIAA,
timeFrame: Study completion, on average 2 weeks
measure: The AUROC curve of the MIAA result, using MLE from all of the available images of non-biopsied PLs, compared to the clinical assessment
timeFrame: Study completion, on average 2 weeks
Other outcomes:
measure: Impact of patient characteristics on the AUROC assessment of MIAA
timeFrame: Study completion, on average 2 weeks
measure: Impact of the image variables on the AUROC assessment of MIAA
timeFrame: Study completion, on average 2 weeks
measure: Impact of the assessing clinician's level of experience on the AUROC assessment of MIAA
timeFrame: Study completion, on average 2 weeks
measure: The concordance between the referring clinician's level of confidence for biopsy and the MIAA result
timeFrame: Study completion, on average 2 weeks
Locations:
city: Exeter
country: United Kingdom
facility: Royal Devon and Exeter
state: Devon
city: Leytonstone
country: United Kingdom
facility: Whipps Corss Hospital
state: London
city: Stoke
country: United Kingdom
facility: Royal Stoke University Hospital
state: Staffordshire
city: Dudley
country: United Kingdom
facility: Russells Hall Hospital
state: West Midlands
city: Bristol
country: United Kingdom
facility: Bristol Royal Infirmary
city: London
country: United Kingdom
facility: Royal Free London NHS Foundation Trust
city: Oxford
country: United Kingdom
facility: Churchill Hospital
Study officials:
affiliation: Royal Free London NHS Foundation Trust
name: Ioulios Palamaras, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: