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

October 23, 2023 updated by: Chengli Li, Shandong Provincial Hospital
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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

334

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Jinan, China
        • Shandong PH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shandong Provincial Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 30, 2023

Primary Completion (Estimated)

September 30, 2025

Study Completion (Estimated)

September 30, 2030

Study Registration Dates

First Submitted

October 17, 2023

First Submitted That Met QC Criteria

October 23, 2023

First Posted (Actual)

October 24, 2023

Study Record Updates

Last Update Posted (Actual)

October 24, 2023

Last Update Submitted That Met QC Criteria

October 23, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SWYX NO 2023-1035

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Early Hepatocellular Carcinoma

Clinical Trials on MWA

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Italy

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe