Pragmatic RCT of AI-Assisted Reading for Malignant Hepatic Lesions on CE-CT
2026年8月14日 更新者：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.
調査の概要
状態
まだ募集していません
詳細な説明
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.
研究の種類
介入
入学 (推定)
40000
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Yu MD PhD Shi
- 電話番号：+86 189 4025 9980
- メール：18940259980@163.com
研究場所
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Liaoning
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Shenyang、Liaoning、中国、110004
- Shengjing Hospital of China Medical University
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コンタクト：
- Yu Shi, MD
- 電話番号：+86 189 4025 9980
- メール：18940259980@163.com
-
コンタクト：
- Yu MD PhD Shi, MD
- 電話番号：+86 189 4025 9980
- メール：18940259980@163.com
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
はい
説明
Inclusion Criteria:
- Age range 18 years and above
- Underwent dynamic contrast-enhanced abdominal CT examination with liver coverage
- Imaging must include at least three required phases: non-contrast, arterial phase, and venous phase; a delayed phase is optional
- Complete imaging data that meet AI system and radiologist interpretation requirements.
Exclusion Criteria:
- 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
- History of recent hepatic trauma (within 30 days)
- Poor image quality or severe noise artifacts (e.g., metal or motion artifacts)
- 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)
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：診断
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：AI-on: AI-assisted abdominal CE-CT reporting
Intervention: AI-assisted interpretation of abdominal CE-CT
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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.
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アクティブコンパレータ：AI-off: Standard abdominal CE-CT reporting without AI assistance
Routine interpretation of abdominal CE-CT without access to AI system (standard of care)
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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.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Per-participant rate of missed clinically significant liver malignancy
時間枠：From the index CE-CT examination through 12 months
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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.
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From the index CE-CT examination through 12 months
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Senior-review workload
時間枠：Up to 24 hours after the eligible CE-CT examination becomes available for interpretation
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Number of examinations requiring senior radiologist review per 100 eligible CE-CT examinations, compared between AI-assisted and standard-reporting center-days.
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Up to 24 hours after the eligible CE-CT examination becomes available for interpretation
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Final report turnaround time
時間枠：Up to 24 hours after the complete CE-CT examination becomes available for interpretation
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Time in minutes from availability of the complete CE-CT examination for interpretation to authorization of the final clinical report.
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Up to 24 hours after the complete CE-CT examination becomes available for interpretation
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Detection rate of clinically significant malignant liver lesions
時間枠：From the index CE-CT examination through 12 months
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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.
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From the index CE-CT examination through 12 months
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Clinically appropriate management-change rate
時間枠：From the index CE-CT examination through 12 months
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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.
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From the index CE-CT examination through 12 months
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Time to initiation of treatment for liver malignancy
時間枠：From the index CE-CT examination through 12 months
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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.
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From the index CE-CT examination through 12 months
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- 主任研究者：Yu Shi, MD、Shengjing Hospital
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- Ding W, Meng Y, Ma J, Pang C, Wu J, Tian J, Yu J, Liang P, Wang K. Contrast-enhanced ultrasound-based AI model for multi-classification of focal liver lesions. J Hepatol. 2025 Aug;83(2):426-439. doi: 10.1016/j.jhep.2025.01.011. Epub 2025 Jan 21.
- Ying H, Liu X, Zhang M, Ren Y, Zhen S, Wang X, Liu B, Hu P, Duan L, Cai M, Jiang M, Cheng X, Gong X, Jiang H, Jiang J, Zheng J, Zhu K, Zhou W, Lu B, Zhou H, Shen Y, Du J, Ying M, Hong Q, Mo J, Li J, Ye G, Zhang S, Hu H, Sun J, Liu H, Li Y, Xu X, Bai H, Wang S, Cheng X, Xu X, Jiao L, Yu R, Lau WY, Yu Y, Cai X. A multicenter clinical AI system study for detection and diagnosis of focal liver lesions. Nat Commun. 2024 Feb 7;15(1):1131. doi: 10.1038/s41467-024-45325-9.
- Elias-Cabot E, Romero-Martin S, Raya-Povedano JL, Rodriguez-Ruiz A, Alvarez-Benito M. AI-based triage and decision support in mammography and digital tomosynthesis for breast cancer screening: a paired, noninferiority trial. Nat Med. 2026 Apr;32(4):1296-1305. doi: 10.1038/s41591-026-04277-x. Epub 2026 Mar 19.
- Woznitza N, Smith L, Rawlinson J, Au-Yong I, George B, Djearaman MG, Nair A, Lee RW, Navani N, Ndwandwe S, Clarke CS, Creeden A, Newsome J, Das I, Abaokporo S, Tucker R, Hathorn J, Baldwin DR. AI-based chest X-ray prioritization in the lung cancer diagnostic pathway: the LungIMPACT randomized controlled trial. Nat Med. 2026 May;32(5):1737-1744. doi: 10.1038/s41591-026-04253-5. Epub 2026 Mar 24.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年8月17日
一次修了 (推定)
2027年12月31日
研究の完了 (推定)
2027年12月31日
試験登録日
最初に提出
2026年8月11日
QC基準を満たした最初の提出物
2026年8月14日
最初の投稿 (実際)
2026年8月17日
学習記録の更新
投稿された最後の更新 (実際)
2026年8月17日
QC基準を満たした最後の更新が送信されました
2026年8月14日
最終確認日
2026年8月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- SH-Lion2RCT--Intervention
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
はい
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
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