NCT05445973

Brief Summary

Contrast-enhanced ultrasonography (CEUS)-CT/MRI fusion imaging substantially improved the visibility of small tumors that were inconspicuous on both US and US-CT/MRI fusion imaging, contributing to successful percutaneous radiofrequency ablation.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
248

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2019

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2021

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2022

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 17, 2022

Completed
19 days until next milestone

First Posted

Study publicly available on registry

July 6, 2022

Completed
Last Updated

July 6, 2022

Status Verified

June 1, 2022

Enrollment Period

2.3 years

First QC Date

June 17, 2022

Last Update Submit

June 30, 2022

Conditions

Radiofrequency AblationUltrasonographyLiver Tumors

Keywords

Percutaneous Radiofrequency AblationReal-Time Contrast-Enhanced UltrasonographySmall Liver Tumors

Outcome Measures

Primary Outcomes (1)

  • Local tumor progression rate

    Evaluate local tumor progression by follow-up computed tomography (CT) or magnetic resonance imaging (MRI)

    12 months after the radiofrequency ablation

Secondary Outcomes (1)

  • Technical success rate of radiofrequency ablation using contrast-enhanced US-CT/MRI fusion image

    Immediately after radiofrequency ablation

Study Arms (1)

Real-Time Contrast-Enhanced Ultrasonography-CT/MRI Fusion Guidance

EXPERIMENTAL

To investigate whether CEUS-CT/MRI fusion imaging improved the visualization of small (≤ 3 cm) primary and secondary malignant liver tumors that were inconspicuous on B-mode US for percutaneous RFA.

Procedure: Percutaneous Radiofrequency Ablation

Interventions

Percutaneous Radiofrequency AblationPROCEDURE

In brief, ablation was performed using a 200-W multichannel generator and a switching monopolar technique with separate clustered electrodes. Tumor targeting was done under the guidance of CEUS-CT/MRI FI, and the ablation procedure was monitored with US-FI. The ablation procedure was terminated when the operator expected to complete the ablation of the index tumor with a minimum 5-mm ablative margin on the US-FI images.

Real-Time Contrast-Enhanced Ultrasonography-CT/MRI Fusion Guidance

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • inconspicuous or invisible index tumors for ablation on US
  • tumor size ≤ 3 cm
  • pathologic diagnosis of primary or secondary liver malignancy or imaging-based diagnosis of HCC according to the American Association for the Study of Liver Disease guidelines or viable HCC according to the Liver Imaging Reporting and Data System treatment response algorithm
  • consideration of curative-intent RFA

You may not qualify if:

  • well-visible tumors (visibility score of 3 or 4) on the planning B-mode US
  • the absence of available data from multiphase CT or MRI performed in the 3-month pre-procedure period
  • poor quality registration of US-CT/MRI fusion imaging and RFA planned with palliative intent
  • contraindications for the conventional RFA procedure at the authors' institution, which are uncontrollable coagulopathy (platelet count \< 50,000/μL or international standard ratio ≥ 1.6), a low level of cooperation, impracticality of sedation, portal vein thrombus, the tumor abutting the portal vein, or larger bile ducts than the segmental branches

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, Jongno-gu, 03080, South Korea

Location

Related Publications (11)

  • Lee DH, Lee JM. Recent Advances in the Image-Guided Tumor Ablation of Liver Malignancies: Radiofrequency Ablation with Multiple Electrodes, Real-Time Multimodality Fusion Imaging, and New Energy Sources. Korean J Radiol. 2018 Jul-Aug;19(4):545-559. doi: 10.3348/kjr.2018.19.4.545. Epub 2018 Jun 14.

    PMID: 29962861BACKGROUND

  • Ahmed M, Solbiati L, Brace CL, Breen DJ, Callstrom MR, Charboneau JW, Chen MH, Choi BI, de Baere T, Dodd GD 3rd, Dupuy DE, Gervais DA, Gianfelice D, Gillams AR, Lee FT Jr, Leen E, Lencioni R, Littrup PJ, Livraghi T, Lu DS, McGahan JP, Meloni MF, Nikolic B, Pereira PL, Liang P, Rhim H, Rose SC, Salem R, Sofocleous CT, Solomon SB, Soulen MC, Tanaka M, Vogl TJ, Wood BJ, Goldberg SN; International Working Group on Image-Guided Tumor Ablation; Interventional Oncology Sans Frontieres Expert Panel; Technology Assessment Committee of the Society of Interventional Radiology; Standard of Practice Committee of the Cardiovascular and Interventional Radiological Society of Europe. Image-guided tumor ablation: standardization of terminology and reporting criteria--a 10-year update. J Vasc Interv Radiol. 2014 Nov;25(11):1691-705.e4. doi: 10.1016/j.jvir.2014.08.027. Epub 2014 Oct 23.

    PMID: 25442132BACKGROUND

  • Feng K, Ma KS. Value of radiofrequency ablation in the treatment of hepatocellular carcinoma. World J Gastroenterol. 2014 May 28;20(20):5987-98. doi: 10.3748/wjg.v20.i20.5987.

    PMID: 24876721BACKGROUND

  • Gao J, Wang SH, Ding XM, Sun WB, Li XL, Xin ZH, Ning CM, Guo SG. Radiofrequency ablation for single hepatocellular carcinoma 3 cm or less as first-line treatment. World J Gastroenterol. 2015 May 7;21(17):5287-94. doi: 10.3748/wjg.v21.i17.5287.

    PMID: 25954102BACKGROUND

  • Lee DH, Kim JW, Lee JM, Kim JM, Lee MW, Rhim H, Hur YH, Suh KS. Laparoscopic Liver Resection versus Percutaneous Radiofrequency Ablation for Small Single Nodular Hepatocellular Carcinoma: Comparison of Treatment Outcomes. Liver Cancer. 2021 Feb;10(1):25-37. doi: 10.1159/000510909. Epub 2021 Jan 14.

    PMID: 33708637BACKGROUND

  • Lee MW, Kang D, Lim HK, Cho J, Sinn DH, Kang TW, Song KD, Rhim H, Cha DI, Lu DSK. Updated 10-year outcomes of percutaneous radiofrequency ablation as first-line therapy for single hepatocellular carcinoma < 3 cm: emphasis on association of local tumor progression and overall survival. Eur Radiol. 2020 Apr;30(4):2391-2400. doi: 10.1007/s00330-019-06575-0. Epub 2020 Jan 3.

    PMID: 31900708BACKGROUND

  • Dietrich CF, Nolsoe CP, Barr RG, Berzigotti A, Burns PN, Cantisani V, Chammas MC, Chaubal N, Choi BI, Clevert DA, Cui X, Dong Y, D'Onofrio M, Fowlkes JB, Gilja OH, Huang P, Ignee A, Jenssen C, Kono Y, Kudo M, Lassau N, Lee WJ, Lee JY, Liang P, Lim A, Lyshchik A, Meloni MF, Correas JM, Minami Y, Moriyasu F, Nicolau C, Piscaglia F, Saftoiu A, Sidhu PS, Sporea I, Torzilli G, Xie X, Zheng R. Guidelines and Good Clinical Practice Recommendations for Contrast-Enhanced Ultrasound (CEUS) in the Liver-Update 2020 WFUMB in Cooperation with EFSUMB, AFSUMB, AIUM, and FLAUS. Ultrasound Med Biol. 2020 Oct;46(10):2579-2604. doi: 10.1016/j.ultrasmedbio.2020.04.030. Epub 2020 Jul 24.

    PMID: 32713788BACKGROUND

  • Mauri G, Cova L, De Beni S, Ierace T, Tondolo T, Cerri A, Goldberg SN, Solbiati L. Real-time US-CT/MRI image fusion for guidance of thermal ablation of liver tumors undetectable with US: results in 295 cases. Cardiovasc Intervent Radiol. 2015 Feb;38(1):143-51. doi: 10.1007/s00270-014-0897-y. Epub 2014 May 8.

    PMID: 24806953BACKGROUND

  • Minami Y, Kudo M. Review of dynamic contrast-enhanced ultrasound guidance in ablation therapy for hepatocellular carcinoma. World J Gastroenterol. 2011 Dec 7;17(45):4952-9. doi: 10.3748/wjg.v17.i45.4952.

    PMID: 22174544BACKGROUND

  • Francica G, Meloni MF, Riccardi L, de Sio I, Terracciano F, Caturelli E, Iadevaia MD, Amoruso A, Roselli P, Chiang J, Scaglione M, Pompili M. Ablation treatment of primary and secondary liver tumors under contrast-enhanced ultrasound guidance in field practice of interventional ultrasound centers. A multicenter study. Eur J Radiol. 2018 Aug;105:96-101. doi: 10.1016/j.ejrad.2018.05.030. Epub 2018 May 31.

    PMID: 30017305BACKGROUND

  • Lee Y, Yoon JH, Han S, Joo I, Lee JM. Contrast-enhanced ultrasonography-CT/MRI fusion guidance for percutaneous ablation of inconspicuous, small liver tumors: improving feasibility and therapeutic outcome. Cancer Imaging. 2024 Jan 3;24(1):4. doi: 10.1186/s40644-023-00650-y.

    PMID: 38172949DERIVED

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Catheter Ablation

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Intervention Hierarchy (Ancestors)

Radiofrequency AblationRadiofrequency TherapyTherapeuticsAblation TechniquesSurgical Procedures, Operative

Study Officials

  • Jeong Min Lee

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 17, 2022

First Posted

July 6, 2022

Study Start

January 1, 2019

Primary Completion

April 30, 2021

Study Completion

January 30, 2022

Last Updated

July 6, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)