AI-Augmented Skin Cancer Diagnosis in Teledermatoscopy

Trial Title: AI-Augmented Skin Cancer Diagnosis in Teledermatoscopy

NCT ID: NCT06080711

Condition: Skin Cancer
Melanoma

Conditions: Official terms:
Melanoma
Skin Neoplasms

Conditions: Keywords:
melanoma
artificial intelligence
AI augmentation
deep learning
teledermatoscopy
dermatoscopy
skin cancer

Study type: Interventional

Study phase: N/A

Overall status: Enrolling by invitation

Study design:

Allocation: Randomized

Intervention model: Crossover Assignment

Primary purpose: Diagnostic

Masking: None (Open Label)

Intervention:

Intervention type: Other
Intervention name: AI assistance
Description: Participants will be informed of the diagnostic probabilities for each of ten differential diagnoses according to the AI tool
Arm group label: Workflow 2
Arm group label: Workflow 3

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.

Criteria for eligibility:
Criteria:
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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: Accepts Healthy Volunteers

Locations:

Facility:
Name: Karolinska University Hospital

Address:
City: Stockholm
Country: Sweden

Start date: February 15, 2023

Completion date: October 30, 2024

Lead sponsor:
Agency: Karolinska University Hospital
Agency class: Other

Collaborator:
Agency: Karolinska Institutet
Agency class: Other

Collaborator:
Agency: Medical University of Vienna
Agency class: Other

Collaborator:
Agency: Stockholm School of Economics
Agency class: Other

Source: Karolinska University Hospital

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06080711