Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Pragmatic RCT of AI-Assisted Reading for Malignant Hepatic Lesions on CE-CT

14. august 2026 opdateret af: Yu Shi, Shengjing Hospital

A Multicenter Randomized Controlled Trial of AI-Assisted Reading Compared With Standard Radiology Interpretation for Malignant Hepatic Lesions on Contrast-Enhanced CT: Diagnostic, Clinical and Workflow Outcomes

The purpose of this multicenter pragmatic randomized controlled trial is to determine whether AI-assisted interpretation of multiphasic liver contrast-enhanced computed tomography (CE-CT) is non-inferior to standard radiology reporting with respect to missed clinically significant malignant focal liver lesions, **with the non-inferiority margin prespecified in the statistical analysis plan before enrollment**, and whether it improves lesion detection, diagnostic characterization, downstream clinical management, and reporting efficiency. On AI-assisted center-days, AI results will be revealed only after the first-line radiologist has saved an unaided initial assessment and may be used to revise the final report. On control center-days, examinations will be interpreted using the standard radiology workflow without access to AI tools.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Multiphasic contrast-enhanced computed tomography (CE-CT) is widely used to evaluate focal liver lesions, but clinically significant malignancies may be missed or incompletely characterized. This prospective, multicenter, pragmatic, cluster-randomized, center-day crossover trial will compare AI-assisted reporting with standard radiology reporting. Center-days will be assigned in an approximately 1:1 ratio using a centrally generated randomized sequence, and each participant will receive only one workflow. In the AI-assisted arm, the radiologist will save an unaided initial assessment before the locked AI output is revealed and may revise or retain the assessment before authorizing the final report. In the control arm, examinations will be interpreted without access to AI outputs. The primary outcome will be the proportion of participants with a reference-standard-confirmed clinically significant malignant focal liver lesion that was missed or inadequately characterized in the final report. The reference standard will incorporate histopathology, follow-up imaging, multidisciplinary consensus, and relevant clinical records. Non-inferiority will be assessed using a margin prespecified in the statistical analysis plan before enrollment, followed by superiority testing if non-inferiority is demonstrated. Secondary outcomes include senior-review workload, final report turnaround time, detection rate of clinically significant malignant liver lesions, clinically appropriate management-change rate, and time to initiation of treatment for liver malignancy.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

40000

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, 110004
        • Shengjing Hospital of China Medical University
        • Kontakt:
        • 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

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ja

Beskrivelse

Inclusion Criteria:

  1. Age range 18 years and above
  2. Underwent dynamic contrast-enhanced abdominal CT examination with liver coverage
  3. Imaging must include at least three required phases: non-contrast, arterial phase, and venous phase; a delayed phase is optional
  4. Complete imaging data that meet AI system and radiologist interpretation requirements.

Exclusion Criteria:

  1. History of recent upper-abdominal surgery (within 30 days) or major hepatobiliary-pancreatic surgery affecting liver evaluation (e.g., liver transplantation or Whipple procedure); patients with prior simple cholecystectomy or single-lesion interventional procedures are not excluded
  2. History of recent hepatic trauma (within 30 days)
  3. Poor image quality or severe noise artifacts (e.g., metal or motion artifacts)
  4. Missing required imaging phases (required at least non-contrast, arterial, and venous phases) or inadequate scan range (e.g., lower-abdomen CT such as pelvic or rectal scans not covering the liver)

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: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: AI-on: AI-assisted abdominal CE-CT reporting
Intervention: AI-assisted interpretation of abdominal CE-CT
Andet: AI-assisted abdominal CE-CT reporting
After the unaided initial assessment is saved, the locked AI system will display lesion localization, patient-level and lesion-level malignancy probabilities, prespecified lesion-class suggestions, and uncertainty or technical-failure warnings. The first-line radiologist may revise or retain the initial assessment and must record acceptance, rejection, or uncertainty for clinically important AI suggestions. The senior reviewer may view the initial assessment, AI output, and revision history. AI may not autonomously authorize reports, prescribe management, or communicate diagnoses directly to participants.
Aktiv komparator: AI-off: Standard abdominal CE-CT reporting without AI assistance
Routine interpretation of abdominal CE-CT without access to AI system (standard of care)
Andet: Standard abdominal CE-CT reporting without AI assistance
Eligible multiphasic abdominal CE-CT examinations will be interpreted and reported according to the site's standard radiology workflow, including routine senior review where applicable. AI system outputs will not be available to radiologists or clinical staff, and no AI-triggered safety-net review will be performed. Routine report addenda, urgent communication, multidisciplinary review, additional imaging, and subsequent clinical management will remain available according to standard clinical practice.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Per-participant rate of missed clinically significant liver malignancy
Tidsramme: From the index CE-CT examination through 12 months
Proportion of all enrolled participants with at least one reference-standard-confirmed clinically significant liver malignancy, including hepatocellular carcinoma, liver metastasis, or another primary hepatic malignancy, that was not identified or appropriately characterized in the final index CE-CT report. The reference standard will comprise histopathology when available; otherwise, 12-month imaging and clinical follow-up and relevant record linkage, adjudicated by an independent committee masked to allocation. Non-inferiority will be assessed against a margin prespecified before enrollment.
From the index CE-CT examination through 12 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Senior-review workload
Tidsramme: Up to 24 hours after the eligible CE-CT examination becomes available for interpretation
Number of examinations requiring senior radiologist review per 100 eligible CE-CT examinations, compared between AI-assisted and standard-reporting center-days.
Up to 24 hours after the eligible CE-CT examination becomes available for interpretation
Final report turnaround time
Tidsramme: Up to 24 hours after the complete CE-CT examination becomes available for interpretation
Time in minutes from availability of the complete CE-CT examination for interpretation to authorization of the final clinical report.
Up to 24 hours after the complete CE-CT examination becomes available for interpretation
Detection rate of clinically significant malignant liver lesions
Tidsramme: From the index CE-CT examination through 12 months
Proportion of enrolled participants with a reference-standard-confirmed clinically significant malignant liver lesion identified in the final index CE-CT report. Results will be reported overall and for prespecified subgroups, including confirmed HCC smaller than 2 cm, BCLC stage 0 HCC, and liver metastases stratified by primary tumor site.
From the index CE-CT examination through 12 months
Clinically appropriate management-change rate
Tidsramme: From the index CE-CT examination through 12 months
Proportion of participants with an independently adjudicated change in diagnostic evaluation, referral, biopsy, treatment, or surveillance attributable to the final index CE-CT report, including avoidance of unnecessary downstream work-up.
From the index CE-CT examination through 12 months
Time to initiation of treatment for liver malignancy
Tidsramme: From the index CE-CT examination through 12 months
Time in days from the index CE-CT examination to initiation of first anti-hepatic malignancy treatment (surgery, ablation, transarterial therapy, systemic therapy, or radiotherapy) among participants with reference-standard-confirmed malignant liver lesions. Median time and interquartile range will be reported, and the proportion of participants starting treatment within clinically relevant time thresholds (e.g., 30 days, 60 days, 90 days) will be compared between groups.
From the index CE-CT examination through 12 months

Samarbejdspartnere og efterforskere

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

Sponsor

Shengjing Hospital

Efterforskere

  • Ledende efterforsker: Yu Shi, MD, Shengjing Hospital

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

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)

17. august 2026

Primær færdiggørelse (Anslået)

31. december 2027

Studieafslutning (Anslået)

31. december 2027

Datoer for studieregistrering

Først indsendt

11. august 2026

Først indsendt, der opfyldte QC-kriterier

14. august 2026

Først opslået (Faktiske)

17. august 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

17. august 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

14. august 2026

Sidst verificeret

1. august 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • SH-Lion2RCT--Intervention

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Abonner