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

Status: Recruiting
Location: See location...
Intervention Type: Other, Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Healthy Volunteers: f
View:

• Contrast-enhanced CT (CE-CT) images of gastric cancer patients from the Liaoning Cancer Hospital;

• Patients with a definitive postoperative pathological diagnosis of gastric cancer and a clear T-stage classification (T1-T4, including T4a and T4b);

• Imaging data must be complete and of sufficient quality to meet diagnostic and analytical requirements, with no significant artefacts or missing key data;

• Complete clinical and pathological information must be available to establish a diagnostic gold standard for comparison.

⁃ Physician Inclusion Criteria (Image Readers)

• Radiologists holding a valid medical licence;

• From the radiology department of a Grade A tertiary hospital or a non-Grade A tertiary hospital;

• Classified as senior or junior physicians based on clinical experience;

• Voluntarily participating in this study and completing both the non-AI-assisted and AI-assisted image interpretation tasks.

Locations
Other Locations
China
Cancer Hospital of Dalian University of Technology (Liaoning Cancer Hospital & Institute)
RECRUITING
Shenyang
Contact Information
Primary
Guoliang Zheng
zhengboren1@126.com
13322400728
Time Frame
Start Date: 2026-06-18
Estimated Completion Date: 2026-08-07
Participants
Target number of participants: 54
Treatments
Experimental: Standard reading 1
Utilizing the TRACE model to assist radiologists in T-staging. In this arm, participants receive TRACE model assistance in the first reading phase (AI-assisted), followed by independent reading without AI after a 1-month washout period. The temporal order of the intervention is early application.
Experimental: Standard Reading 2
Utilizing the TRACE model to assist radiologists in T-staging. In this arm, participants first perform independent reading without AI assistance, and after a 1-month washout period, they receive TRACE model assistance in the second reading phase. The temporal order of the same intervention is delayed compared to Arm 1.
Related Therapeutic Areas
Sponsors
Leads: Liaoning Cancer Hospital & Institute

This content was sourced from clinicaltrials.gov