Melanoma Image Analysis Algorithm (MIAA) Validation Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

514 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-11

Study Completion Date

2018-07-11

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Prospective, single-arm, cross-sectional, study to establish the effectiveness of MIAA to detect melanoma in pigmented lesions, compared to gold standard histological determination.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Generation of an Artificial Intelligence Algorithm Based on the Analysis of Melanoma Peri-scar Dermatoheliosis, as a Predictive Factor of Response to Anti-PD-1

NCT05856565

Metastatic Melanoma

RECRUITING

Improving Skin Cancer Management With Artificial Intelligence (04.17 SMARTI)

NCT04040114

Skin Cancer Melanoma (Skin)

COMPLETED NA

Artificial Intelligence Based Melanoma Early Diagnosis and Risk Prediction in Children, Adolescents and Young Adults

NCT06621810

Melanoma (Skin Cancer) Artificial Intelligence (AI) Pediatric Cancer

RECRUITING

Diagnostic Precision of the AI Tool Dermalyzer to Identify Malignant Melanomas in Subjects Seeking Primary Care for Melanoma-suspected Cutaneous Lesions

NCT05172232

Malignant Melanoma

COMPLETED

Diagnostic Imaging Study for the Melanoma Advanced Imaging Dermatoscope (mAID)

NCT02470273

Melanoma

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Malignant Melanoma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

All patients

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)

Group Type EXPERIMENTAL

Melanoma Image Analysis Algorithm (MIAA)

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No