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

NCT07582419 | Not Yet Recruiting

• 1 other identifier: 2025-MS-269
• Study Type: observational
• Target: 1,424
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Hepatocellular Carcinoma (HCC)

Keywords

Multimodal; CEUS; Enhanced MRI; Treatment Decisions; hepatocellular carcinoma

Outcome Measures

Primary Outcomes (1)

• 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.

  2 years

Study Arms (2)

Surgical group

The group of patients underwent surgical resection treatment.

Procedure: surgery

Microwave Ablation Group

The group of patients underwent microwave ablation treatment.

Procedure: ablation

Interventions

ablation PROCEDURE

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.

Microwave Ablation Group

surgery PROCEDURE

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.

Surgical group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• The First Hospital of Jilin University: lead
• Chinese PLA General Hospital: collaborator

Study Sites (1)

The First Hospital of jilin University

Changchun, Jilin, China

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Central Study Contacts

Dezhi Zhang

CONTACT

+8618186876068; dezhi@ilu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 26, 2026
• First Posted: May 12, 2026
• Study Start: April 30, 2026
• Primary Completion (Estimated): October 30, 2027
• Study Completion (Estimated): October 30, 2027
• Last Updated: May 12, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)