RecruitingNot ApplicableNCT07651644

Two-component Radiology-guided Autonomous Cascade Engine (TRACE)

Protocol for a Prospective Randomised Crossover Controlled Trial of the Artificial Intelligence-Assisted Decision-Making System for Gastric Cancer T-Staging (TRACE)


Sponsor

Liaoning Cancer Hospital & Institute

Enrollment

54 participants

Start Date

Jun 18, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

This study employed a prospective, randomised crossover trial design to evaluate the clinical utility of the TRACE artificial intelligence system for gastric cancer T-staging. A total of 54 radiologists from tertiary and non-tertiary hospitals, including both senior and junior practitioners, were enrolled. The study aimed to investigate whether AI-assisted diagnosis could improve the diagnostic accuracy of gastric cancer T-staging compared with independent interpretation by radiologists. All participants were required to interpret 60 contrast-enhanced CT cases sequentially, completing two readings for each case: one without AI assistance and one with AI assistance; The order of the two readings was randomised, and a one-month washout period was observed between readings to eliminate memory bias. All cases were pathologically confirmed gastric cancer cases (stages T1-T4b), and the study simultaneously recorded the physicians' T-staging diagnostic results and the time taken per case. The 60 cases per radiologist were randomly selected from a pool of 1,000 histologically confirmed gastric cancer cases, stratified by pathological T stage T1-T4b. The reference standard was postoperative pathological T stage. The primary outcome was the change in T-staging accuracy between AI-assisted reading and standard (unaided) reading.The term "prospective" in this study refers to the prospective execution of radiologist enrollment, randomization, reading procedures, and data collection.


Eligibility

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Utilizing the TRACE model to assist radiologists in T-staging, Utilizing the TRACE model to assist radiologists in T-staging, and others for people with gastric cancer (diagnosis). The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTUtilizing the TRACE model to assist radiologists in T-staging

AI-assisted reading: Radiologists interpret preoperative contrast-enhanced CT images for gastric cancer T staging with the support of the TRACE artificial intelligence decision system. The AI system provides a suggested T stage and relevant imaging features. The radiologist makes the final staging decision after reviewing the AI output. This intervention is used only during the AI-assisted reading session.

OTHERwashout period

Participants are required to observe a washout period of at least 30 days between consecutive interventions/assessments.

DIAGNOSTIC_TESTUtilizing the TRACE model to assist radiologists in T-staging

AI-assisted reading: Radiologists interpret preoperative contrast-enhanced CT images for gastric cancer T staging with the support of the TRACE artificial intelligence decision system. The AI system provides a suggested T stage and relevant imaging features. The radiologist makes the final staging decision after reviewing the AI output. This intervention is used only during the AI-assisted reading session.


Locations(1)

Cancer Hospital of Dalian University of Technology (Liaoning Cancer Hospital & Institute)

Shenyang, Liaoning, China

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NCT07651644


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