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

Shandong First Medical University

Status: Active, not recruiting

Conditions: Early Hepatocellular Carcinoma

Treatments: Procedure: MWA

Study type: Observational

Funder types: Other

Identifiers

NCT06096896

SWYX NO 2023-1035

Details and patient eligibility

About

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.

Enrollment: 334 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

334 participants in 1 patient group

single-group with MWA

Description:

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.

Treatment:

Procedure: MWA