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Early Hepatocellular CarcinomaNCT06096896

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

An observational study of Early Hepatocellular Carcinoma, run by Shandong Provincial Hospital at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Early Hepatocellular Carcinoma
What is being tested?
MWA
Type of treatment
Surgery or procedure
How many people
334 participants
Where
1 siteChina
Study dates
30 Aug 2023to 30 Sep 2030
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Shandong PH

    Jinan

Other trials in China

About this 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.

Being tested
MWA
Keywords
early HCC; microwave ablation; efficacy; safety
Medical subject headings
Carcinoma, Hepatocellular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MWAProcedure or surgery

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

Study groups in NCT06096896
Study groupRoleWhat they receive
single-group with MWA334 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.
Receives: Procedure: MWA

What is being measured

The primary outcome is the main question the study is designed to answer.

  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;

    Measured: 5 years

Secondary outcomes (1)

  1. Rate of completed ablation after MWA

    Ablation effect assessed by EOB-MRI one month after ablation

    Measured: rate of completed ablation at one month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Oct 2023
  2. Study start30 Aug 2023
  3. Primary completion30 Sep 2025 (estimated)
  4. Study completion30 Sep 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
334 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06096896
Sponsor's protocol ID
SWYX NO 2023-1035
Status last verified
Oct 2023
First submitted
17 Oct 2023
Last updated
24 Oct 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 33479224

  • 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. Hepatology. 2009 Feb;49(2):658-64. doi: 10.1002/hep.22709. No abstract available.

    PubMed 19177576

  • 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.

    PubMed 29318354

  • 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 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.

    PubMed 28620797

  • 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.

    PubMed 25153274

  • 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 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.

    PubMed 29437912

  • 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 update. J Hepatol. 2022 Mar;76(3):681-693. doi: 10.1016/j.jhep.2021.11.018. Epub 2021 Nov 19.

    PubMed 34801630

  • 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 S, Takehara T. Management of Hepatocellular Carcinoma in Japan: JSH Consensus Statements and Recommendations 2021 Update. Liver Cancer. 2021 Jun;10(3):181-223. doi: 10.1159/000514174. Epub 2021 May 19.

    PubMed 34239808

  • 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 Trials. Cancers (Basel). 2020 Dec 16;12(12):3796. doi: 10.3390/cancers12123796.

    PubMed 33339274

  • 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/cam4.3923. Epub 2021 May 7.

    PubMed 33960697

  • 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):3790-3797. doi: 10.1007/s00261-021-03008-9. Epub 2021 Mar 6.

    PubMed 33675382

  • 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 reduce the recurrence of hepatocellular carcinoma after radiofrequency ablation. Int J Hyperthermia. 2020;37(1):1149-1158. doi: 10.1080/02656736.2020.1825837.

    PubMed 32996799

Questions about this trial

What is this clinical trial studying?

An observational study of Early Hepatocellular Carcinoma, run by Shandong Provincial Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 24 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

5-years overall survival (OS) after MWA for early HCC (time frame: 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06096896, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2023.

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