Clinical trial · Observational
The Efficacy and Safety of EOB-MRI Guided Microwave Ablation for Early HCC: A Multicenter, Prospective, Observational Study
NCT06096896CI-TRIAL-00070759active not recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Early Hepatocellular Carcinoma | Early Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MWA | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- 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.
- interventionNames
- Procedure: MWA
Primary outcomes (1)
- measure
- 5-years overall survival (OS) after MWA for early HCC
- timeFrame
- 5 years
- description
- Analyze the efficacy and safety of EOB-MRI-guided microwave ablation in the treatment of eHCC;
Secondary outcomes (1)
- measure
- Rate of completed ablation after MWA
- timeFrame
- rate of completed ablation at one month
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (12)
- RESULTLlovet JM, Kelley RK, Villanueva A, Singal AG, Pikarsky E, Roayaie S, Lencioni R, Koike K, Zucman-Rossi J, Finn RS. Hepatocellular carcinoma. Nat Rev Dis Primers. 2021 Jan 21;7(1):6. doi: 10.1038/s41572-020-00240-3. PMID 33479224
- RESULTInternational Consensus Group for Hepatocellular NeoplasiaThe International Consensus Group for Hepatocellular Neoplasia. Pathologic diagnosis of early hepatocellular carcinoma: a report of the international consensus group for hepatocellular neoplasia. Hepatology. 2009 Feb;49(2):658-64. doi: 10.1002/hep.22709. No abstract available. PMID 19177576
- RESULTSirlin CB, Kielar AZ, Tang A, Bashir MR. LI-RADS: a glimpse into the future. Abdom Radiol (NY). 2018 Jan;43(1):231-236. doi: 10.1007/s00261-017-1448-1. PMID 29318354
- RESULTOmata M, Cheng AL, Kokudo N, Kudo M, Lee JM, Jia J, Tateishi R, Han KH, Chawla YK, Shiina S, Jafri W, Payawal DA, Ohki T, Ogasawara S, Chen PJ, Lesmana CRA, Lesmana LA, Gani RA, Obi S, Dokmeci AK, Sarin SK. Asia-Pacific clinical practice guidelines on the management of hepatocellular carcinoma: a 2017 update. Hepatol Int. 2017 Jul;11(4):317-370. doi: 10.1007/s12072-017-9799-9. Epub 2017 Jun 15. PMID 28620797
- RESULTChoi JY, Lee JM, Sirlin CB. CT and MR imaging diagnosis and staging of hepatocellular carcinoma: part I. Development, growth, and spread: key pathologic and imaging aspects. Radiology. 2014 Sep;272(3):635-54. doi: 10.1148/radiol.14132361. PMID 25153274
- RESULTRenzulli M, Biselli M, Brocchi S, Granito A, Vasuri F, Tovoli F, Sessagesimi E, Piscaglia F, D'Errico A, Bolondi L, Golfieri R. New hallmark of hepatocellular carcinoma, early hepatocellular carcinoma and high-grade dysplastic nodules on Gd-EOB-DTPA MRI in patients with cirrhosis: a new diagnostic algorithm. Gut. 2018 Sep;67(9):1674-1682. doi: 10.1136/gutjnl-2017-315384. Epub 2018 Feb 3. PMID 29437912