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AI-Augmented Skin Cancer Diagnosis in Teledermatoscopy (AIDMel)

Primary Purpose

Skin Cancer, Melanoma

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
AI assistance
Sponsored by
Karolinska University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Skin Cancer focused on measuring melanoma, artificial intelligence, AI augmentation, deep learning, teledermatoscopy, dermatoscopy, skin cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Karolinska University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

Workflow 1

Workflow 2

Workflow 3

Arm Description

Standard of care

Consult with AI assistance

First workflow 1, then workflow 2

Outcomes

Primary Outcome Measures

Diagnostic accuracy
Determine 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 decisions
Determine 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 decision
Evaluate which factors affect the likelihood of a physician changing their evaluation after receiving algorithmic input
Self-reported confidence in diagnosis and management decisions
Investigate whether AI or other factors affect the physician's confidence in their diagnosis and management decisions

Secondary Outcome Measures

Full Information

First Posted
August 30, 2023
Last Updated
October 6, 2023
Sponsor
Karolinska University Hospital
Collaborators
Karolinska Institutet, Medical University of Vienna, Stockholm School of Economics
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1. Study Identification

Unique Protocol Identification Number
NCT06080711
Brief Title
AI-Augmented Skin Cancer Diagnosis in Teledermatoscopy
Acronym
AIDMel
Official Title
AI-Augmented Skin Cancer Diagnosis in Teledermatoscopy: A Prospective Randomized Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
February 15, 2023 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
October 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska University Hospital
Collaborators
Karolinska Institutet, Medical University of Vienna, Stockholm School of Economics

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Skin Cancer, Melanoma
Keywords
melanoma, artificial intelligence, AI augmentation, deep learning, teledermatoscopy, dermatoscopy, skin cancer

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Workflow 1
Arm Type
No Intervention
Arm Description
Standard of care
Arm Title
Workflow 2
Arm Type
Experimental
Arm Description
Consult with AI assistance
Arm Title
Workflow 3
Arm Type
Experimental
Arm Description
First workflow 1, then workflow 2
Intervention Type
Other
Intervention Name(s)
AI assistance
Intervention Description
Participants will be informed of the diagnostic probabilities for each of ten differential diagnoses according to the AI tool
Primary Outcome Measure Information:
Title
Diagnostic accuracy
Description
Determine 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
Time Frame
1 year
Title
Accuracy of management decisions
Description
Determine 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)
Time Frame
1 year
Title
Tendency to change initial diagnosis or management decision
Description
Evaluate which factors affect the likelihood of a physician changing their evaluation after receiving algorithmic input
Time Frame
1 year
Title
Self-reported confidence in diagnosis and management decisions
Description
Investigate whether AI or other factors affect the physician's confidence in their diagnosis and management decisions
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Karolinska University Hospital
City
Stockholm
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

AI-Augmented Skin Cancer Diagnosis in Teledermatoscopy

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