Skip to content

The assessment of experimental artificial intelligence (AI) algorithms for the diagnosis of skin tumours against human performance

The assessment of experimental artificial intelligence (AI) algorithms for the diagnosis of skin tumours against human performance

Status
Completed
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12620000695909
Enrollment
190
Registered
2020-06-22
Start date
2020-09-22
Completion date
2022-02-04
Last updated
2023-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The purpose of this study is to compare various artificial intelligence algorithms used for the diagnosis and management of skin tumours against clinician diagnosis and management. Who is it for? You may be eligible for this study if you are an adult and either have previously had taken whole body photographs or have been assessed as requiring a biopsy of a skin lesion by your attending specialist.. Study details Following your routine examination by your attending specialist you will be examined by two other doctors and have images taken of some of your skin lesions by a mobile phone. None of this will effect your management and any tests performed will only be related to your attending specialist's requests. It is hoped that this study will help determine if artificial intelligence can accurately be used for the diagnosis and management of skin tumours.

Interventions

The condition observed is the diagnosis and management of skin tumours. The ground truth can take up to a year to be confirmed. Two groups of patients are recruited - 1. Those with baseline total body photographs taken 1-4 yrs prior to examination. Here, WHOLE BODY EXAMINATION occurs, and all discrete skin lesions are recruited with a > 4 mm longest diameter except for clinically non-suspicious amelanotic actinic keratoses and multiple lesions consistent with an inflammatory skin eruption or eph

The condition observed is the diagnosis and management of skin tumours. The ground truth can take up to a year to be confirmed. Two groups of patients are recruited - 1. Those with baseline total body photographs taken 1-4 yrs prior to examination. Here, WHOLE BODY EXAMINATION occurs, and all discrete skin lesions are recruited with a > 4 mm longest diameter except for clinically non-suspicious amelanotic actinic keratoses and multiple lesions consistent with an inflammatory skin eruption or ephelides. In addition, all discrete lesions > 3 mm that are chosen for excision or monitoring by ground-truth assessment are recruited. 2. Patients undergoing routine excision or biopsy of pigmented skin lesions. Here, only these INDIVIDUAL LESIONS are examined. Clinicians with a variety of clinical expertise (dermatology residents/registrars, specialists) will be recruited with their level of expertise (years using dermoscopy, clinician classification) recorded. One novice clinician (dermatology resident/1st yr registrar) and one expert clinician (specialist in pigmented lesion clinics) will examine the patient. The diagnostic algorithms that will be COMPARED WITH THE CLINICIANS DIAGNOSIS/MANAGEMENT AND GROUND TRUTH are artificial intelligence-based that can be used on mobile phones. In our study, images are taken from the mobile phone of recruited patient lesions by the study researchers and analysed by cloud computing. The result is then returned to the researchers. Doctors and patients are not given the results. The output of these algorithms are Diagnosis (from 7 categories; 1. Melanoma 2. Melanocytic nevus 3. Pigmented Basal cell carcinoma 4. Pigmented Actinic keratosis / Bowen’s disease (intraepithelial carcinoma) 5. Benign (pigmented) keratotic lesion 6. Benign Vascular lesion 7. Dermatofibroma) and Management (dismiss, dermoscopy monitor or biopsy). However, the algorithms DO NOT influence patient management and are not revealed to the attending clinicians or patients. The following AI algorithms from MetaOptima will be used to generate the above results 1. 7-class classification * ISIC 2018 challenge winning model * An ensemble of Taxnet models (standard backbone network with an RNN) * An ensemble of Lesion Localization with Bias Unlearning models (LLBU) 2. Management decision * An ensemble of Taxnet models (standard backbone network with an RNN) to get ben/mal predictions and map to Dismiss | Monitor | Biopsy classes * An ensemble of Lesion Localization with Bias Unlearning models (LLBU) to get ben/mal predictions and map to Dismiss | Monitor | Biopsy classes The Active control = ground truth. Ground truth is determined by a descending hierarchy of: • Histopathology (ie. biopsy changed lesion). • Unchanged lesions on TBP = benign * Changed melanocytic lesions undergo 3-month dermoscopy monitoring (excise if change) • Subsequent unchanged 3-month digital dermoscopy OR insignificant changing long-term monitored lesions = benign • In vivo confocal microscopy (if available). • 2 of 2 independent readers viewing the dermoscopy images of changed lesions that are clinically benign (eg. Seborrheic keratoses, hemangiomas) = benign

Sponsors

MetaOptima Technology Inc
Lead SponsorCommercial sector/Industry

Eligibility

Sex/Gender
All
Age
18 Years to 99 Years
Healthy volunteers
No

Inclusion criteria

A. Whole body examination 1. Patients with baseline total body photographs (TBP) taken within 1-4 years of examination 2. Gender: Male or Female 3. Age range: 18-99yrs 4. Modified Fitzpatrick I-III Skin Type 5. Willingness and ability to provide informed consent and to participate and comply with the study requirements. B. Individual lesion examination 1. Patients undergoing an excision/biopsy of a pigmented skin lesion. 2. Gender: Male or Female 3. Age range: 18-99yrs 4. Modified Fitzpatrick I-III Skin Type 5. Willingness and ability to provide informed consent and to participate and comply with the study requirements.

Exclusion criteria

Not meeting all inclusion criteria for either group A or B.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 10, 2026