Hepatocellular Carcinoma (HCC)HDL-CEUS-MRINCT07582419
Hybrid Deep Learning Integrating Multimodal CEUS and Enhanced MRI to Optimize Early-Stage HCC Treatment Decisions
An observational study of Hepatocellular Carcinoma (HCC), run by The First Hospital of Jilin University at 1 site in China.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Hepatocellular Carcinoma (HCC)
- What is being tested?
- surgery and ablation
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 1,424 participants
- Where
- 1 siteChina
- Study dates
- 30 Apr 2026to 30 Oct 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Hepatocellular Carcinoma (HCC)
- Being tested
- surgery, ablation
- Keywords
- Multimodal, CEUS, Enhanced MRI, Treatment Decisions, hepatocellular carcinoma
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surgeryProcedure or surgery
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.
ablationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Surgical group | The group of patients underwent surgical resection treatment. Receives: Procedure: surgery | |
| Microwave Ablation Group | The group of patients underwent microwave ablation treatment. Receives: Procedure: ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early recurrence status (binary: recurrence vs. non-recurrence within 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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2026
- Study start30 Apr 2026 (estimated)
- Primary completion30 Oct 2027 (estimated)
- Study completion30 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular Carcinoma (HCC)Studies of the same condition, open and under way.
- More trials run by The First Hospital of Jilin UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,424 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Hospital of Jilin University
- Sponsor type
- University, hospital or other
- Collaborators
- Chinese PLA General Hospital
- Responsible party
- Principal investigator, Dezhi Zhang, The First Hospital of Jilin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07582419
- Sponsor's protocol ID
- 2025-MS-269
- Acronym
- HDL-CEUS-MRI
- Status last verified
- May 2026
- First submitted
- 26 Apr 2026
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hybrid Deep Learning Models Based on Multimodal CEUS and Enhanced MRI Can Optimize Treatment Decisions for Early-stage Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT07582419
- Acronym / sponsor ID
- HDL-CEUS-MRI / 2025-MS-269
- Conditions
- Hepatocellular Carcinoma (HCC)
- Keywords
- Multimodal, CEUS, Enhanced MRI, Treatment Decisions, hepatocellular carcinoma
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,424 participants (estimated)
- Lead sponsor
- The First Hospital of Jilin UniversityUniversity, hospital or other
- Collaborators
- Chinese PLA General Hospital
- Study start
- 30 Apr 2026 (estimated)
- Primary completion
- 30 Oct 2027 (estimated)
- Study completion
- 30 Oct 2027 (estimated)
- First posted
- 12 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgical group | – | Procedure: surgeryThe group of patients underwent surgical resection treatment. |
| Microwave Ablation Group | – | Procedure: ablationThe group of patients underwent microwave ablation treatment. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| surgeryThe 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. | Procedure or surgery | Surgical group |
| ablationAblation 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. | Procedure or surgery | Microwave Ablation Group |
Primary outcome
Early recurrence status (binary: recurrence vs. non-recurrence within 2 years)
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatocellular Carcinoma (HCC), run by The First Hospital of Jilin University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dezhi Zhang (+8618186876068, dezhi@ilu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Early recurrence status (binary: recurrence vs. non-recurrence within 2 years) (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2026.