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NCT Number: NCT06096896

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Early Hepatocellular Carcinoma Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Shandong PH

Jinan, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

MWA

Procedure

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

Primary outcomes

  1. 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;

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Shandong Provincial Hospital

Other Gov

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2030
First posted
Oct 24, 2023
Registry last updated
Oct 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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