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

NCT06096896 | Active Not Recruiting

• 1 other identifier: SWYX NO 2023-1035
• Study Type: observational
• Target: 334
• Locations: 1 country
• Sites: 1

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.

Conditions

Early Hepatocellular Carcinoma

Keywords

early HCC; microwave ablation; efficacy; safety

Outcome Measures

Primary Outcomes (1)

• 5-years overall survival (OS) after MWA for early HCC

  Analyze the efficacy and safety of EOB-MRI-guided microwave ablation in the treatment of eHCC;

  5 years

Secondary Outcomes (1)

• Rate of completed ablation after MWA

  rate of completed ablation at one month

Study Arms (1)

single-group with 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.

Procedure: MWA

Interventions

MWA PROCEDURE

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

single-group with MWA

Eligibility Criteria

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

Study Population

Patients with chronic liver disease at high-risk or extremely high-risk of hepatocellular carcinoma and EOB-MRI shows a confirmed or suspected eHCC.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Shandong Provincial Hospital: lead

Study Sites (1)

Shandong PH

Jinan, China

Location

Related Publications (12)

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MeSH Terms

Conditions

Carcinoma, Hepatocellular

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of imaging magnetic resonance interventional diagnosis and Treatment Department, Shandong Provincial Hospital

Study Record Dates

• First Submitted: October 17, 2023
• First Posted: October 24, 2023
• Study Start: August 30, 2023
• Primary Completion: September 30, 2025
• Study Completion (Estimated): September 30, 2030
• Last Updated: October 24, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)