Esta página se tradujo automáticamente y no se garantiza la precisión de la traducción. por favor refiérase a versión inglesa para un texto fuente.

Hybrid Deep Learning Integrating Multimodal CEUS and Enhanced MRI to Optimize Early-Stage HCC Treatment Decisions (HDL-CEUS-MRI)

7 de mayo de 2026 actualizado por: 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.

Descripción general del estudio

Estado

Aún no reclutando

Descripción detallada

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 de estudio

De observación

Inscripción (Estimado)

1424

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Dezhi Zhang
  • Número de teléfono: +8618186876068
  • Correo electrónico: dezhi@ilu.edu.cn

Ubicaciones de estudio

    • Jilin
      • Changchun, Jilin, Porcelana
        • The First Hospital of Jilin University

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Método de muestreo

Muestra no probabilística

Población de estudio

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.

Descripción

Inclusion Criteria:

  1. Preoperative enhanced imaging examination or pathological diagnosis is HCC;
  2. CNLC Stage I, IIa, Child-Pugh Class A/B;
  3. A single tumor with a diameter ≤ 5 cm or 2-3 tumors, with the maximum diameter ≤ 3 cm;
  4. Perform liver resection surgery or MWA surgery treatment;
  5. 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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

Cohortes e Intervenciones

Grupo / Cohorte
Intervención / Tratamiento
Surgical group
The group of patients underwent surgical resection treatment.
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.
Microwave Ablation Group
The group of patients underwent microwave ablation treatment.
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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Early recurrence status (binary: recurrence vs. non-recurrence within 2 years)
Periodo de tiempo: 2 years
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.
2 years

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

30 de abril de 2026

Finalización primaria (Estimado)

30 de octubre de 2027

Finalización del estudio (Estimado)

30 de octubre de 2027

Fechas de registro del estudio

Enviado por primera vez

26 de abril de 2026

Primero enviado que cumplió con los criterios de control de calidad

7 de mayo de 2026

Publicado por primera vez (Actual)

12 de mayo de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

12 de mayo de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

7 de mayo de 2026

Última verificación

1 de mayo de 2026

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

Suscribir