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CompletedNCT02705118FAME-USUpdated May 25, 2017

Evaluation of Performance of Automatic Fusion for Radiofrequency Ablation of Hepatocellular Carcinoma

An interventional study of Automatic Imaging fusion of ultrasonography and MRI and Manual Imaging fusion of ultrasonography and MRI in Hepatocellular Carcinoma, sponsored by JOON-IL CHOI. Completed at 1 site in Korea, Republic of. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2017-05-25.

Sponsored by JOON-IL CHOI · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
82
Allocation
Randomized
Ages
40 Years and older
Sex
All
01

Study summary

Fusion imaging of US and MRI is very helpful for interventional procedure such as radiofrequency ablation in liver. However, manual registration of US and magnetic resonance (MR) imaging is somewhat time-consuming and difficult for less-experienced physicians. Recently, automatic registration function was developed to help the fusion of US and CT/MRI imaging. The purpose of this trial is to compare the registration time and accuracy of manual registration system and automatic registration system.

Read the detailed description
  1. Patients will be randomized and assigned.
  2. For automatic registration group, automatic image fusion will be done by RS80A US unit and RF ablation will be performed. Image fusion time will be measured.
  3. For manual registration group, manual image fusion will be done by LOGIQ-E9 US unit and RF ablation will be performed. Image fusion time will be measured.
  1. After radiofrequency (RF) ablation, immediate, contrast enhanced CT will be performed to evaluate technical success and complications 4) Accuracy of registration will be measured by home-made software using 3D techniques.
  1. After one month, technical effectiveness will be evaluated by contrast enhanced CT 6) F/U of CT images will be obtained until one year after RF ablation with a interval of 1-3 months.
02

Conditions studied

  • Hepatocellular Carcinoma

Keywords

  • radiofrequency ablation
  • image fusion
03

In context

Carcinoma

6,741 studies on the registry are indexed under Carcinoma; 1,163 are open to participants now.

This study's enrollment of 82 is above the median of 45 across 5,174 interventional studies indexed under Carcinoma.

Browse Carcinoma studies →

Lead sponsor

JOON-IL CHOI is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • More than 40-years old
  • Patients with hepatic malignancy who will underwent radiofrequency ablation

Exclusion criteria

Exclusion Criteria:

  • Not using fusion imaging (CT guidance or fluoroscopic guidance)
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
82 participants (actual)

Study arms

  • Experimental
    Automatic registration arm

    Automatic registration for fusion imaging of US and MRI will be performed. Automatic Imaging fusion of ultrasonography and MRI

    Device: Automatic Imaging fusion of ultrasonography and MRI

  • Active comparator
    Manual registration arm

    Manual registration for fusion imaging of US and MRI will be performed. Manual Imaging fusion of ultrasonography and MRI

    Device: Manual Imaging fusion of ultrasonography and MRI

Interventions

  • DeviceAutomatic Imaging fusion of ultrasonography and MRI

    Radiofrequency ablation for hepatic malignancies will be performed with automatic registration registration. Except the imaging registration, all other procedures for RF ablation is same.

  • DeviceManual Imaging fusion of ultrasonography and MRI

    Radiofrequency ablation for hepatic malignancies will be performed with manual registration registration. Except the imaging registration, all other procedures for RF ablation is same.

06

What researchers measure

Primary outcomes

  1. Registration accuracy

    Accuracy of imaging fusion (US and MRI)

    Time frame: Immediately after RF ablation

Secondary outcomes

  1. Technical success

    Completeness of tumor ablation

    Time frame: Within 48 hours after RF ablation

  2. Technical effectiveness

    Completeness of tumor ablation

    Time frame: One month after RF ablation

  3. Registration time

    Time required for registration

    Time frame: Within 48 hours after RF ablation

07

Study locations

1 site
  • Seoul St.Mary's Hospital
    Seoul, 06591, Korea, Republic of
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 25, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02705118
Lead sponsor
JOON-IL CHOI
Responsible party
JOON-IL CHOI (Associate professor, Seoul St. Mary's Hospital) — Sponsor-investigator
First posted
Mar 10, 2016
Start date
Dec 2015
Primary completion
Mar 31, 2017
Completion
Mar 31, 2017
Last update
May 25, 2017

Study contacts

Joon-Il Choi
principal investigator · Seoul St. Mary's Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2017. You cannot join it, but the record below documents what was studied.

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