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临床试验/NCT07582419
NCT07582419尚未招募不适用

Hybrid Deep Learning Models Based on Multimodal CEUS and Enhanced MRI Can Optimize Treatment Decisions for Early-stage Hepatocellular Carcinoma

The First Hospital of Jilin University1 个研究点 分布在 1 个国家目标入组 1,424 人开始时间: 2026年4月30日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
1,424
试验地点
1

研究概览

简要总结

This study aims to address the issue of a lack of individualized basis for selecting liver resection (LH) or microwave ablation (MWA) in early-stage hepatocellular carcinoma (HCC) patients to reduce the early recurrence rate (≤2 years). Given that existing machine learning-based recurrence prediction studies have failed to guide the optimal treatment plan selection, and that multidisciplinary consultations rely on guidelines (universality) and experience (subjectivity) which have their limitations, we propose to utilize artificial intelligence (AI), specifically the advantages of multimodal deep learning technology (which outperforms traditional machine learning by integrating complementary information to provide more accurate predictions), to establish a hybrid deep learning model that integrates contrast-enhanced ultrasound (CEUS) and enhanced magnetic resonance imaging (MRI) features. This model will predict the probability of early recurrence (ER≤2 years) in patients and, based on this, recommend LH or MWA as the optimal first treatment option for newly diagnosed early HCC patients to optimize individualized treatment decisions.

详细描述

Core ObjectiveTo develop a hybrid deep learning model based on contrast-enhanced ultrasound (CEUS) clinical data for predicting the early recurrence (ER) probability within 2 years after liver resection (LH) or microwave ablation (MWA) in patients with early-stage liver cancer (CNLC I/IIa), providing a basis for individualized treatment decisions.Key MethodsStudy DesignType: Multicenter retrospective cohort study (2009.10-2026.12, 30 hospitals)Population:Inclusion: First diagnosed HCC (single lesion ≤5cm or 2-3 lesions with the largest ≤3cm), Child-Pugh A/B grade, CEUS/MRI examination within one month before surgery.Exclusion: Extrahepatic metastasis/other malignancies, previous treatment history, missing imaging/follow-up data.Sample size: 1441 cases (LH group 609 cases, MWA group 831 cases).Data CollectionClinical Data: Age, hepatitis type, cirrhosis, tumor characteristics (size/location/number), laboratory indicators (AFP, etc.).Imaging Data:CEUS: Dynamic acquisition of arterial phase (AP), portal venous phase (PVP), and delayed phase (LP) videos after SonoVue injection.Enhanced MRI: Acquisition of AP, PVP, transitional phase (TP), and hepatobiliary-specific phase (HBP) images after Gd-EOB-DTPA enhancement.Follow-Up: Imaging re-examination (CEUS/CT/MRI) every 3-6 months within 2 years after surgery, with endpoints being recurrence/death/last follow-up (≥24 months).Model ConstructionInput Data:Imaging ROI: Manual drawing of the tumor and a 5mm peritumoral area, extracting 64×64 pixel frames (CEUS videos downsampled to 32 frames).Fusion Methods: Clinical CEUS, clinical MRI, and clinical CEUS MRI.Deep Learning Architecture:Feature Extraction: 2D-CNN (convolutional layers → spatial features) → Bi-LSTM (fusion of spatiotemporal features) → Attention module.Data Augmentation: Translation and flipping to reduce overfitting.Training/Validation:5-fold cross-validation, dividing the training/validation set in a 4:1 ratio (training LH and MWA groups separately).Optimal Model Selection: The one with the highest AUC.Decision ApplicationHybrid model: To predict the ER probabilities for LH or MWA treatment for the same patient separately.Treatment Recommendations:If the predicted ER probability: MWA > LH → recommend LH;If the predicted ER probability: LH ≥ MWA → recommend MWA.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Preoperative enhanced imaging examination or pathological diagnosis is HCC;
  • CNLC Stage I, IIa, Child-Pugh Class A/B;
  • A single tumor with a diameter ≤ 5 cm or 2-3 tumors, with the maximum diameter ≤ 3 cm;
  • Perform liver resection surgery or MWA surgery treatment;
  • MRI and/or CEUS examinations performed within one month before surgery

排除标准

  • 1:There is already extrahepatic metastasis or the presence of other malignant tumors;
  • 2: History of other treatments prior to surgery;
  • 3: Incomplete preoperative ultrasound contrast and/or MRI imaging data, with images missing or unclear;
  • 4: Missing postoperative follow-up data

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dezhi Zhang

Principal Investigator

The First Hospital of Jilin University

研究点 (1)

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