The Efficacy and Safety of EOB-MRI Guided Microwave Ablation for Early HCC: A Multicenter, Prospective, Observational Study

Active, not recruiting

• Conditions: Early Hepatocellular Carcinoma
• Interventions: Procedure: MWA

• Registration Number: NCT06096896
• Lead Sponsor: Shandong Provincial Hospital

Brief Summary

HCC is one of most common causes of cancer-related death in the world due to lately diagnosis by typical hallmarks which rely on completed arterialization. So it is important to earlier diagnose and treat hypovascular early HCC(eHCC). The aim of this study is to evaluate the efficacy and safety of microwave ablation for early HCC, also to explore the feasibility of EOB-MRI (Gd-EOB-DTPA enhanced MRI) guided ablation.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-08-30
• Status Verified: 2023-10
• Study First Submitted: 2023-10-17
• Study First Submitted QC: 2023-10-23
• Last Update Submitted: 2023-10-23
• Study First Posted: 2023-10-24
• Last Update Posted: 2023-10-24
• Primary Completion: 2025-09-30
• Study Completion: 2030-09-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 334

Inclusion Criteria

1. Age ≥ 18 years;
2. Patients with chronic liver disease who are at high/extremely high-risk of hepatocellular carcinoma;
3. EOB-MRI suggestive of confirmed or suspected eHCC (single lesion ≤ 2 cm or number of lesions ≤ 3 and maximum diameter ≤ 2 cm)
4. No previous history of hepatocellular carcinoma;
5. Not receiving any anti-cancer treatment;
6. Liver function Child-push A or B.

Exclusion Criteria

1. Presence of lymph nodes or distant metastases;
2. Presence of liver metastases;
3. Prior malignancy;
4. Severe cardiopulmonary or renal dysfunction;
5. Suffering from uncorrectable coagulation dysfunction (prothrombin time > 25 seconds, prothrombin activity < 40%, platelet count ≤ 50x10^9/L);
6. Severe infectious lesions in the area of the puncture needle tract.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
single-group with MWA	MWA	334 patients with confirmed or suspected eHCC as indicated by EOB-MRI were to be included in this study in a population with high or extremely high-risk of hepatocellular carcinoma in chronic liver disease. Then Microwave ablation (MWA) was performed under EOB-MRI guidance in patients with confirmed or suspected eHCC.

Primary Outcome Measures

Name	Time	Method
5-years overall survival (OS) after MWA for early HCC	5 years	Analyze the efficacy and safety of EOB-MRI-guided microwave ablation in the treatment of eHCC;

Secondary Outcome Measures

Name	Time	Method
Rate of completed ablation after MWA	rate of completed ablation at one month	Ablation effect assessed by EOB-MRI one month after ablation

Trial Locations

Locations (1)

Shandong PH; 🇨🇳 Jinan, China