Evaluation of Performance of Automatic Fusion for Radiofrequency Ablation of Hepatocellular Carcinoma (FAME-US)

May 23, 2017 updated by: JOON-IL CHOI

Evaluation of Performance of S-fusion for Radiofrequency Ablation of Hepatocellular Carcinoma: A Randomized, Prospective Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

3) 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.

5) 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.

Study Type

Interventional

Enrollment (Actual)

82

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Radiofrequency ablation for hepatic malignancies will be performed with automatic registration registration. Except the imaging registration, all other procedures for RF ablation is same.
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
Radiofrequency ablation for hepatic malignancies will be performed with manual registration registration. Except the imaging registration, all other procedures for RF ablation is same.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Registration accuracy
Time Frame: Immediately after RF ablation
Accuracy of imaging fusion (US and MRI)
Immediately after RF ablation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Technical success
Time Frame: Within 48 hours after RF ablation
Completeness of tumor ablation
Within 48 hours after RF ablation
Technical effectiveness
Time Frame: One month after RF ablation
Completeness of tumor ablation
One month after RF ablation
Registration time
Time Frame: Within 48 hours after RF ablation
Time required for registration
Within 48 hours after RF ablation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

JOON-IL CHOI

Investigators

  • Principal Investigator: Joon-Il Choi, Seoul St. Mary's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2015

Primary Completion (Actual)

March 31, 2017

Study Completion (Actual)

March 31, 2017

Study Registration Dates

First Submitted

December 15, 2015

First Submitted That Met QC Criteria

March 5, 2016

First Posted (Estimate)

March 10, 2016

Study Record Updates

Last Update Posted (Actual)

May 25, 2017

Last Update Submitted That Met QC Criteria

May 23, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KC15DNSI0039

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hepatocellular Carcinoma

Clinical Trials on Automatic Imaging fusion of ultrasonography and MRI

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Uzbekistan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe