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AI-Augmented Skin Cancer Diagnosis in Teledermatoscopy

AI-Augmented Skin Cancer Diagnosis in Teledermatoscopy: A Prospective Randomized Study

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06080711
Acronym
AIDMel
Enrollment
30
Registered
2023-10-12
Start date
2023-02-15
Completion date
2024-10-30
Last updated
2023-10-12

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

Conditions

Melanoma, Skin Cancer

Keywords

melanoma, artificial intelligence, AI augmentation, deep learning, teledermatoscopy, dermatoscopy, skin cancer

Brief summary

In this study an artificial intelligence (AI) tool for skin cancer diagnosis is implemented in a teleldermatoscopy platform. The aim is to study the effects on clinician diagnostic accuracy, management decisions, and confidence. Furthermore, this prospective randomized study investigates the role of human factors in determining clinician reliance on AI tools and the consequent accuracy in a real-world setting.

Detailed description

Deep-learning algorithms can potentially benefit many areas in healthcare, including the diagnosis of skin cancer using teledermatoscopy. However, there is a dearth of clinical, prospective research on human-AI interaction in diagnostic tasks that take human factors into account. In this study we will examine the impact of such factors in a real-world setting where we integrate an algorithm in an existing teledermatoscopy platform that is used clinically at a tertiary hospital in Sweden. We will investigate what impact various implementations of AI tool output in relation to human factors have on diagnostic accuracy and management decisions. Study subjects are recruited at the Department of Dermatology at Karolinska University Hospital and will be asked to rate prospective teledermatoscopic consults with and without AI-support. Each consult will be randomized into one of three workflows with or without one pre-defined implementation of the AI tool. Study subjects are also asked to complete two surveys with demographic information and questions relating to various human factors. Patients participating in the study will be diagnosed outside the study prior to inclusion without any involvement of an AI tool, notably by two experienced dermatologists who do not participate as study subjects.

Interventions

OTHERAI assistance

Participants will be informed of the diagnostic probabilities for each of ten differential diagnoses according to the AI tool

Sponsors

Karolinska Institutet
CollaboratorOTHER
Medical University of Vienna
CollaboratorOTHER
Stockholm School of Economics
CollaboratorUNKNOWN
Karolinska University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Licensed physician * Working at a dermatology clinic * Sufficient knowledge in Swedish * Written consent to participate

Exclusion criteria

* No experience of using dermatoscopy * Does not wish to participate * Incomplete answers * Physicians that are involved in the patients' clinical care relating to the teledermoscopical consult

Design outcomes

Primary

MeasureTime frameDescription
Diagnostic accuracy1 yearDetermine sensitivity, specificity, accuracy and AUROC in terms of diagnostic accuracy for dermatologists with vs without AI advice. Further, to investigate the role of the different workflows (diagnosis with or without AI with varying sequencing) and the influence of demographics and human factors (e.g. level of experience) on diagnostic accuracy
Accuracy of management decisions1 yearDetermine sensitivity, specificity, accuracy and AUROC in terms of accuracy for management decisions for dermatologists with vs without AI and investigate the role of the different workflows (with or without AI with varying sequencing) and the influence of demographics and human factors (e.g. level of experience) on management decisions (biopsy/surgery, no intervention, or follow-up)
Tendency to change initial diagnosis or management decision1 yearEvaluate which factors affect the likelihood of a physician changing their evaluation after receiving algorithmic input
Self-reported confidence in diagnosis and management decisions1 yearInvestigate whether AI or other factors affect the physician's confidence in their diagnosis and management decisions

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026