Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07468357

Human-AI Uncertainty Callibration for Improved Skin Lesion Segmentation

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Board certified dermatologists with clinical experience in dermoscopic diagnosis.

Exclusion criteria

  • Doctors who have not yet finished their specialization and dermatologists.
  • Dermatologists without clinical experience in dermoscopic diagnosis.

Treatment and study plan

Base Model

Other

See arm description.

Other names: Intervention 1

FDM

Other

See arm description

Other names: Final Decision Model, Intervention 2

Primary outcomes

  1. Accuracy

    Time frame: Immediately after the intervention.

    Diagnostic accuracy in differentiating between melanoma, nevus, and benign keratosis. Defined as the percentage of correct diagnoses. Ground truth is based on histopathologically verified diagnoses.

Secondary outcomes

  1. Uncertainty

    Time frame: Immediately after the intervention.

    Changes in self-assesed uncertainty ranging from 0 (very uncertain) to 10 (very certain) from pre- to post-intervention.

  2. Cut-off uncertainty

    Time frame: Immediately after the intervention.

    The self-assessed uncertainty of cases where the participant has clicked a "would you like to discuss this case with a collegue"-button.

Other outcomes

  1. Time

    Time frame: Immediately after the intervention.

    Time from the start to finish of each case with a split time corresponding to the end of the control phase (the time "Show AI input"-button is clicked).

Study contacts

Contact information is provided by the study sponsor or research team.

Julie Renata Bjerremand

CONTACT

[email protected]

+45 53593700

Sponsors and collaborators

Lead sponsor

Copenhagen Academy for Medical Education and Simulation

Other

Collaborators

  • Technical University of Denmark

Registry information

Official study title

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.

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 12, 2026
Registry last updated
Mar 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.