Hybrid Deep Learning Integrating Multimodal CEUS and Enhanced MRI to Optimize Early-Stage HCC Treatment Decisions (HDL-CEUS-MRI)
7 maggio 2026 aggiornato da: Dezhi Zhang, The First Hospital of Jilin University
Hybrid Deep Learning Models Based on Multimodal CEUS and Enhanced MRI Can Optimize Treatment Decisions for Early-stage Hepatocellular Carcinoma
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.
Panoramica dello studio
Stato
Non ancora reclutamento
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Osservativo
Iscrizione (Stimato)
1424
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Contatto studio
- Nome: Dezhi Zhang
- Numero di telefono: +8618186876068
- Email: dezhi@ilu.edu.cn
Luoghi di studio
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Jilin
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Changchun, Jilin, Cina
- The First Hospital of Jilin University
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
No
Metodo di campionamento
Campione non probabilistico
Popolazione di studio
Hepatocellular carcinoma (HCC) patients who underwent microwave ablation (MWA) or surgical resection (liver hepatectomy, LH) at the First Hospital of Jilin University, the PLA General Hospital, and 18 other hospitals between October 2009 and May 2023, and who received contrast-enhanced ultrasound and/or MRI examinations prior to the procedure.
Descrizione
Inclusion Criteria:
- 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
Exclusion Criteria:
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
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Surgical group
The group of patients underwent surgical resection treatment.
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The surgery was performed in supine position under general anesthesia with open/laparoscopic liver resection (LH), and the main and secondary incisions were made based on the tumor location.
Intraoperative ultrasound was routinely used to assess the tumor, remnant liver volume, and the feasibility of negative margins.
The type of liver resection followed established guidelines.
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Microwave Ablation Group
The group of patients underwent microwave ablation treatment.
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Ablation is performed under ultrasound guidance and intravenous anesthesia, using the KY-2000 treatment device with disposable ablation needles and monitoring software.
For tumors with a diameter of less than 2cm, a single needle is used; for tumors of 2cm or more, dual needles (needle spacing ≤ 2cm) are used.
The ablation parameters are set to a power of 40-65W and a duration of 1-15 minutes, with immediate post-operative ultrasound (contrast) assessment of the ablation range.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Early recurrence status (binary: recurrence vs. non-recurrence within 2 years)
Lasso di tempo: 2 years
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Follow-up strategy (telephone follow-up or clinical database): Routine check-ups, serum AFP tests, contrast-enhanced ultrasound (CEUS), or enhanced CT/MRI examinations are performed at 1, 3, 6 months, 1 year, and 2 years after treatment to confirm tumor recurrence.
Follow-up starts from the date of surgery and ends at the first recurrence, death, or last follow-up (≥24 months).
Early recurrence is defined as recurrence occurring within 2 years after surgical treatment.
The outcome is recorded as a binary variable: recurrence (yes) or no recurrence (no) within 2 years.
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2 years
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Collaboratori
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Stimato)
30 aprile 2026
Completamento primario (Stimato)
30 ottobre 2027
Completamento dello studio (Stimato)
30 ottobre 2027
Date di iscrizione allo studio
Primo inviato
26 aprile 2026
Primo inviato che soddisfa i criteri di controllo qualità
7 maggio 2026
Primo Inserito (Effettivo)
12 maggio 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
12 maggio 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
7 maggio 2026
Ultimo verificato
1 maggio 2026
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 2025-MS-269
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
NO
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
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