Human-AI Collaboration for Ultrasound Diagnosis of Thyroid Nodules - a Clinical Trial

Rigshospitalet

Status: Completed

Conditions: Thyroid Nodule

Treatments: Diagnostic Test: S-Detect for Thyroid

Study type: Interventional

Funder types: Other

Identifiers

NCT06306599

Thyroid AI US operator exp

Details and patient eligibility

About

This is an experimental study wherein groups of medical students and physicians of varying degrees of experience in head-and-neck ultrasound were asked to scan the same five patients each with a thyroid nodule.

The study participants did their own ultrasound assessment of the thyroid nodules, as well as using an AI-based ultrasound diagnostics system.

The researchers intended to study two primary outcomes: 1) how varying degrees of experience in ultrasound by the operator might affect the diagnostic performance of the AI-based system, and 2) how the AI-based system influenced the diagnostic performance of the ultrasound operator.

Full description

This is a prospective clinical study aiming to test how the experience of the ultrasound operator influences the performance of AI-based (artificial intelligence-based) diagnostics when analysing thyroid nodules on ultrasound scans. The investigators set up an experiment with five stations, each with a patient with a thyroid nodule and an ultrasound machine with the deep learning based system S-Detect for Thyroid installed. 20 study participants where recruited: 8 medical students of novice ultrasound skill, 3 junior ENT (ear-nose-throat) registrars of intermediate ultrasound skill, and 9 senior ENT registrars experienced in ultrasound. The participants scanned all the patients and recorded their analyses of the nodules using the EUTIRADS (European thyroid imagining reporting and data system) system in three different ways: a analysis of their own, S-Detect's analysis, and an analysis combining the two previous.

The hypothesis was that the AI system would perform equally well when between the participant groups. In addition, it was expected that the experienced participants would perform better than the students without AI help, and that the doctors would gain little from AI input, but that the students would have their performance improved by AI input.

Enrollment: 20 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Medical students

Inclusion Criteria:

• Last year student

Exclusion Criteria:

• Experience with ultrasound beyond that which is taught at the University of Copenhagen

Junior ENT registrar doctors

Inclusion Criteria:

• Doctor enrolled in introductory training as ENT physician.

Senior ENT registrar doctors

Inclusion Criteria:

• Doctor enrolled in ENT training.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Experiment

Experimental group

Description:

20 participants ultrasound scan five patients with thyroid nodules, and assess these nodules themselves, then with the AI-program, and at last they give a combined assessment.

Treatment:

Diagnostic Test: S-Detect for Thyroid