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

11. juni 2026 opdateret af: Guoliang Zheng, Liaoning Cancer Hospital & Institute

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

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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

The TRACE trial is a prospective, randomized, crossover, controlled study evaluating an artificial intelligence (AI)-assisted decision system for T staging of gastric cancer based on CT images.

Background and rationale: Accurate preoperative T staging is critical for treatment planning in gastric cancer, but remains challenging due to reader variability and imaging limitations. The AI system was developed using deep learning with a large multi-center dataset to improve staging accuracy.

Study design: Eligible patients with pathologically confirmed gastric cancer will undergo preoperative contrast-enhanced CT. Each participant will be assessed twice in random order: once with AI assistance (AI arm) and once without (standard arm). A washout period will be applied between the two readings to minimize recall bias. Radiologists involved in the study are blinded to clinical and pathological reference standards.

Objective: To compare the T staging accuracy (primary outcome) between AI-assisted and standard reading, with secondary outcomes including inter-reader agreement, reading time, and diagnostic confidence.

Statistical methods: A crossover design will be used with a sample size calculated to detect a prespecified difference in overall accuracy. The primary analysis will employ a paired McNemar test or generalized estimating equation accounting for period and carryover effects. Subgroup analyses by tumor location, T category, and reader experience will be exploratory.

Data monitoring: No independent Data Monitoring Committee is required due to the low-risk nature of the diagnostic device. Adverse events related to the use of the software (e.g., workflow disruption) will be recorded and reported.

Ethics and dissemination: The protocol has been approved by the Ethics Committee of Liaoning Cancer Hospital & Institute. Written informed consent (online or paper-based) will be obtained from all participants. Results will be submitted for publication in peer-reviewed journals regardless of outcome.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

54

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Kina
    • Liaoning
      • Shenyang, Liaoning, Kina, 110024
        • Rekruttering
        • Cancer Hospital of Dalian University of Technology (Liaoning Cancer Hospital & Institute)
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn
  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria (Imaging Data)

  1. Contrast-enhanced CT (CE-CT) images of gastric cancer patients from the Liaoning Cancer Hospital;
  2. Patients with a definitive postoperative pathological diagnosis of gastric cancer and a clear T-stage classification (T1-T4, including T4a and T4b);
  3. Imaging data must be complete and of sufficient quality to meet diagnostic and analytical requirements, with no significant artefacts or missing key data;
  4. Complete clinical and pathological information must be available to establish a diagnostic gold standard for comparison.

Physician Inclusion Criteria (Image Readers)

  1. Radiologists holding a valid medical licence;
  2. From the radiology department of a Grade A tertiary hospital or a non-Grade A tertiary hospital;
  3. Classified as senior or junior physicians based on clinical experience;
  4. Voluntarily participating in this study and completing both the non-AI-assisted and AI-assisted image interpretation tasks.

Case Exclusion Criteria

  1. Severe missing imaging data or quality failing to meet analysis requirements (e.g., severe motion artefacts);
  2. Lack of clear postoperative pathological T-staging results;
  3. Cases not involving gastric cancer or with incomplete pathological information;
  4. Cases of duplicate enrolment or inconsistent data recording.

Physician Exclusion Criteria

  1. Those unable to complete all image review tasks or demonstrating severe non-compliance;
  2. Those who withdraw during the study period and are unable to provide complete data for both phases of image review;
  3. Those who fail to complete the AI-assisted and non-AI-assisted interpretation processes as specified.

Withdrawal Criteria

  1. Physicians who voluntarily withdraw from the study for personal reasons (e.g., time, health or work commitments);
  2. Physicians who fail to complete the required image review tasks or have data missing in excess of the specified threshold;
  3. Cases where critical data errors are identified during subsequent verification or where pathological results cannot be traced; Data found during the study to be non-compliant with ethical or quality control requirements must be excluded.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Diagnostisk
  • Tildeling: Randomiseret
  • Interventionel model: Crossover opgave
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Diagnostisk test: Utilizing 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.
Andet: washout period
Participants are required to observe a washout period of at least 30 days between consecutive interventions/assessments.
Eksperimentel: 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.
Diagnostisk test: Utilizing 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.
Andet: washout period
Participants are required to observe a washout period of at least 30 days between consecutive interventions/assessments.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Accuracy
Tidsramme: Within 40 days after the first radiologist initiates image reading.
Accuracy of radiologists' interpretation of T staging
Within 40 days after the first radiologist initiates image reading.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Accuracy Change by Physician Experience Level
Tidsramme: Within 40 days after the first radiologist initiates image reading.
Changes in diagnostic accuracy of radiologists with different experience levels before and after AI assistance.
Within 40 days after the first radiologist initiates image reading.
Stratified diagnostic accuracy of different T-stages
Tidsramme: Within 40 days after the first radiologist initiates image reading.
Stratified diagnostic accuracy for different T-stages (T1-T4, including T4a and T4b).
Within 40 days after the first radiologist initiates image reading.
Agreement between physician diagnosis and pathological gold standard
Tidsramme: Within 40 days after the first radiologist initiates image reading.
Agreement between radiologists' diagnostic results and the pathological gold standard (e.g., Kappa value).
Within 40 days after the first radiologist initiates image reading.
Agreement between AI model and physician interpretation
Tidsramme: Within 40 days after the first radiologist initiates image reading.
Agreement analysis between AI model prediction results and radiologists' interpretations.
Within 40 days after the first radiologist initiates image reading.
Effect of AI assistance on reading efficiency
Tidsramme: Within 40 days after the first radiologist initiates image reading.
Changes in average reading time for diagnosis with and without AI assistance.
Within 40 days after the first radiologist initiates image reading.

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Influence of case characteristics on AI assistance effect
Tidsramme: Within 40 days after the first radiologist initiates image reading.
Influence of different case characteristics (e.g., tumor location, size) on the performance of AI assistance.
Within 40 days after the first radiologist initiates image reading.
Impact of individual physician differences on AI assistance effect
Tidsramme: Within 40 days after the first radiologist initiates image reading.
Impact of individual differences among physicians on the performance of AI assistance.
Within 40 days after the first radiologist initiates image reading.
Value of AI assistance in reducing diagnostic discrepancy
Tidsramme: Within 40 days after the first radiologist initiates image reading.
Potential value of AI assistance in reducing diagnostic differences and improving reading agreement.
Within 40 days after the first radiologist initiates image reading.
Impact of model probability information on physician decisions
Tidsramme: Within 40 days after the first radiologist initiates image reading.
Preliminary analysis of the impact of probability output from AI model on physician decision-making behavior.
Within 40 days after the first radiologist initiates image reading.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Liaoning Cancer Hospital & Institute

Efterforskere

  • Ledende efterforsker: Guoliang Zheng, Cancer Hospital of Dalian University of Technology (Liaoning Cancer Hospital & Institute)

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

18. juni 2026

Primær færdiggørelse (Anslået)

25. juli 2026

Studieafslutning (Anslået)

7. august 2026

Datoer for studieregistrering

Først indsendt

11. juni 2026

Først indsendt, der opfyldte QC-kriterier

11. juni 2026

Først opslået (Faktiske)

16. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

16. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

11. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • KY20260512

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

Due to the restrictions imposed by the ethics committee and the institutional review board regarding the protection of patient privacy, individual participant data will not be shared.

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