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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06096896

Enrollment

334

Registered

2023-10-24

Start date

2023-08-30

Completion date

2030-09-30

Last updated

2023-10-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Early Hepatocellular Carcinoma

Keywords

early HCC; microwave ablation; efficacy; safety

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.

Interventions

PROCEDUREMWA

Microwave ablation (MWA) was performed under EOB-MRI guidance in patients with confirmed or suspected eHCC.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
Rate of completed ablation after MWA	rate of completed ablation at one month	Ablation effect assessed by EOB-MRI one month after ablation

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026