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

Early Hepatocellular Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06096896
• Other study ID #: SWYX NO 2023-1035
• Status: Active, not recruiting
• Start date: August 30, 2023
• Est. completion date: September 30, 2030

Study information

• Verified date: October 2023
• Source: Shandong Provincial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 334
• Est. completion date: September 30, 2030
• Est. primary completion date: September 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Early Hepatocellular Carcinoma

Intervention

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

Locations

Country	Name	City	State
China	Shandong PH	Jinan

Sponsors (1)

Lead Sponsor	Collaborator
Shandong Provincial Hospital

Country where clinical trial is conducted

China, 

References & Publications (12)

Chen L, Ren Y, Sun T, Cao Y, Yan L, Zhang W, Ouyang T, Zheng C. The efficacy of radiofrequency ablation versus cryoablation in the treatment of single hepatocellular carcinoma: A population-based study. Cancer Med. 2021 Jun;10(11):3715-3725. doi: 10.1002/ — View Citation

Choi 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. — View Citation

Facciorusso A, Abd El Aziz MA, Tartaglia N, Ramai D, Mohan BP, Cotsoglou C, Pusceddu S, Giacomelli L, Ambrosi A, Sacco R. Microwave Ablation Versus Radiofrequency Ablation for Treatment of Hepatocellular Carcinoma: A Meta-Analysis of Randomized Controlled — View Citation

International 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. H — View Citation

Kudo M, Kawamura Y, Hasegawa K, Tateishi R, Kariyama K, Shiina S, Toyoda H, Imai Y, Hiraoka A, Ikeda M, Izumi N, Moriguchi M, Ogasawara S, Minami Y, Ueshima K, Murakami T, Miyayama S, Nakashima O, Yano H, Sakamoto M, Hatano E, Shimada M, Kokudo N, Mochida — View Citation

Llovet 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. — View Citation

Omata 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 — View Citation

Reig M, Forner A, Rimola J, Ferrer-Fabrega J, Burrel M, Garcia-Criado A, Kelley RK, Galle PR, Mazzaferro V, Salem R, Sangro B, Singal AG, Vogel A, Fuster J, Ayuso C, Bruix J. BCLC strategy for prognosis prediction and treatment recommendation: The 2022 up — View Citation

Renzulli 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 i — View Citation

Sirlin 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. — View Citation

Suwa K, Seki T, Aoi K, Yamashina M, Murata M, Yamashiki N, Nishio A, Shimatani M, Naganuma M. Efficacy of microwave ablation versus radiofrequency ablation for hepatocellular carcinoma: a propensity score analysis. Abdom Radiol (NY). 2021 Aug;46(8):3790-3 — View Citation

Wang F, Numata K, Nihonmatsu H, Chuma M, Moriya S, Nozaki A, Ogushi K, Fukuda H, Ruan L, Okada M, Luo W, Koizumi N, Nakano M, Otani M, Inayama Y, Maeda S. Intraprocedurally EOB-MRI/US fusion imaging focusing on hepatobiliary phase findings can help to red — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Rate of completed ablation after MWA	Ablation effect assessed by EOB-MRI one month after ablation	rate of completed ablation at one month