NCT04844112

Brief Summary

To prospectively evaluate the technical success rate of real-time computed tomography/CT/magnetic resonance imagingMR and -ultrasound (CT/MRI-US) automatic fusion system and the long-term therapeutic efficacy of radiofrequency ablation (RFA) guided by automatic fusion in hepatocellular carcinoma (HCC) patients.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
139

participants targeted

Target at P50-P75 for not_applicable hepatocellular-carcinoma

Timeline
Completed

Started Aug 2015

Shorter than P25 for not_applicable hepatocellular-carcinoma

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

August 1, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2016

Completed
4.4 years until next milestone

First Submitted

Initial submission to the registry

April 6, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 14, 2021

Completed
Last Updated

April 14, 2021

Status Verified

April 1, 2021

Enrollment Period

1.3 years

First QC Date

April 6, 2021

Last Update Submit

April 8, 2021

Conditions

Hepatocellular Carcinoma

Keywords

Radiofrequency ablationFusion imaging

Outcome Measures

Primary Outcomes (3)

  • Technical success rate of the fusion process

    Absolute technical success rate of the fusion process

    Immediately after fusion process

  • Technical success rate of the overall RFA procedure

    Absolute technical success rate of the overall RFA compared to literature

    immediately after RFA procedure

  • Rate of complete ablation of the tumor after 1 month clinical follow up

    Rate of complete ablation of the tumor after 1 month clinical follow up compared to literature

    1 month after the RFA procedure

Secondary Outcomes (4)

  • Local tumor progression rate

    During post procedural follow up to 5 years

  • Tumor visibility before and after the fusion process

    10 minutes after finishing planning USG

  • Technical feasibility before and after the fusion process

    10 minutes after finishing planning USG

  • Safety of the approach route before and after the fusion process

    10 minutes after finishing planning USG

Study Arms (1)

Experimental arm

EXPERIMENTAL

patients undergo routine conventional feasibility planning ultrasound, and clinical decision of RFA feasibility is made based on conventional planning ultrasound. Then additional planning ultrasound using automatic CT/US fusion technique is immediately performed by the same operator, and clinical decision is made based on fusion imaging.

Procedure: automatic CT/MRI-US fusion system guided radiofrequency ablation

Interventions

automatic CT/MRI-US fusion system guided radiofrequency ablationPROCEDURE

automatic CT/MRI-US fusion system guided radiofrequency ablation

Experimental arm

Eligibility Criteria

Age20 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Pathologic or typical imaging based diagnosis of HCC
  • Multiphase CT or MRI within 3 months ahead of procedure
  • No evidence of distant metastasis
  • No contraindications for conventional RFA procedure in our institute, which are uncontrolled coagulopathy (international standard ratio ≥ 1.6, or platelet \> 50,000), poor cooperation, unfeasible for sedation, portal vein tumor thrombus, tumor number \>4, largest tumor size \> 5cm, and tumors abutting portal vein or bile ducts bigger than segmental branches.

You may not qualify if:

  • Lack of multiphase CT or MRI withing 3 months ahead of procedure
  • RFA planned for palliative purpose
  • Diagnosed as non-HCC malignancy
  • Right hepatectomy state

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

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

Study Officials

  • Jeong Min Lee

    Professor

    STUDY CHAIR

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

April 6, 2021

First Posted

April 14, 2021

Study Start

August 1, 2015

Primary Completion

November 30, 2016

Study Completion

November 30, 2016

Last Updated

April 14, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share