NCT07468357

Human-AI Uncertainty Callibration for Improved Skin Lesion Segmentation

The Effect of Human-AI Uncertainty Calibration vs. AI Uncertainty Alone on the Diagnostic Accuracy of Human Experts for Skin Lesions - a Randomized Controlled Trial.

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Copenhagen Academy for Medical Education and Simulation · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Accepted

Summary

The goal of this randomized controlled study is to compare the effect of a new, personalized uncertainty-aware decision model (FDM) to a standard image recognition model in improving the diagnostic accuracy while reducing diagnostic uncertainty in experienced dermatologists tasked with differentiating between melanomas, moles and other benign skin lesions. The main question it aims to answer: Is the FDM a feasible method for an improved human AI partnership in which trust is build, misdiagnoses are avoided, and uncertainty is duly introduced or reduced. The investigators expect to see only a slight increase in collective diagnostic accuracy for both interventions as the the human participants are skilled dermatologist and thus have high accuracies pre-intervention. The investigators expect to see a higher increase in diagnostic certainty for the FDM intervention compared to the diagnostic certainty in the Base Model intervention. The investigators expect to see a higher amount of diagnosis changes from incorrect to correct in the FDM group compared to the Base Model group. The investigators do not expect any learning effect during the study. Participants will start by answering a series of training cases consisting of images of skin lesions. These are used to train their individual FDM (only for the FDM-intervention group). From here, the participants will be randomized into two arms determining which of the two interventions they are exposed to. The participants will solve each case withouth any intervention first, and this reply will act as a control.

Detailed description

A detailed description of the FDM is presented in the references.

Conditions

• Skin Lesions

Interventions

Type	Name	Description
OTHER	Base Model	See arm description.
OTHER	FDM	See arm description

Timeline

• Start date: 2026-03-01
• Primary completion: 2026-07-01
• Completion: 2026-11-01
• First posted: 2026-03-12
• Last updated: 2026-03-12