AI-Assisted Chest CT Interpretation Across the Lung Cancer Care Continuum

N/ANot Yet RecruitingNCT07829640

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology15 enrolled

Overview

This investigator-initiated, single-center study consists of a retrospective artificial intelligence model-development stage and a prospective physician reader-study stage. Deidentified chest CT examinations acquired during routine clinical care between January 1, 2021, and December 31, 2024, will be used to develop, validate, and lock artificial intelligence models for lung cancer-related imaging tasks. In the prospective stage, approximately 12 to 15 physicians with experience in chest CT interpretation will complete two reading sessions in randomized order: unaided interpretation and AI-assisted interpretation. The sessions will be separated by a washout period of at least 4 weeks. The primary objective is to compare diagnostic performance between AI-assisted and unaided interpretation. Secondary objectives include reading time, diagnostic confidence, inter-reader agreement, and errors related to incorrect AI suggestions. All readings will be performed in an offline research environment. AI outputs will not be used for patient care, and the study will not add imaging examinations, treatment, or follow-up for patients.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Lung Cancer

Interventions

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Physicians with education or training relevant to medical imaging * Experience in interpreting chest CT examinations * Ability to complete the required study training and both reading sessions * Willingness to provide written informed consent and comply with study procedures Exclusion Criteria: * Failure to complete the required study training * Inability or unwillingness to complete both reading sessions as required * Any protocol deviation likely to compromise the validity of the reader-study data

Outcomes

Primary Outcomes

Difference in Diagnostic Accuracy Between AI-Assisted and Unaided Chest CT Interpretation

Diagnostic accuracy will be calculated as the proportion of case-level interpretations that agree with the prespecified reference standard based on pathology or clinical follow-up. The paired difference in diagnostic accuracy between AI-assisted and unaided interpretation will be estimated across participating physicians and cases using a multi-reader multi-case analysis and reported with a 95% confidence interval. Higher accuracy indicates better diagnostic performance.

Time frame: At completion of the second reading session, after a washout period of at least 4 weeks