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

Primary Purpose

Hepatocellular Carcinoma

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Automatic Imaging fusion of ultrasonography and MRI
Manual Imaging fusion of ultrasonography and MRI
Sponsored by
JOON-IL CHOI
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring radiofrequency ablation, image fusion

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Seoul St.Mary's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Automatic registration arm

Manual registration arm

Arm Description

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

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

Outcomes

Primary Outcome Measures

Registration accuracy
Accuracy of imaging fusion (US and MRI)

Secondary Outcome Measures

Technical success
Completeness of tumor ablation
Technical effectiveness
Completeness of tumor ablation
Registration time
Time required for registration

Full Information

First Posted
December 15, 2015
Last Updated
May 23, 2017
Sponsor
JOON-IL CHOI
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1. Study Identification

Unique Protocol Identification Number
NCT02705118
Brief Title
Evaluation of Performance of Automatic Fusion for Radiofrequency Ablation of Hepatocellular Carcinoma
Acronym
FAME-US
Official Title
Evaluation of Performance of S-fusion for Radiofrequency Ablation of Hepatocellular Carcinoma: A Randomized, Prospective Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
December 2015 (Actual)
Primary Completion Date
March 31, 2017 (Actual)
Study Completion Date
March 31, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
JOON-IL CHOI

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed Description
Patients will be randomized and assigned. 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma
Keywords
radiofrequency ablation, image fusion

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
82 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Automatic registration arm
Arm Type
Experimental
Arm Description
Automatic registration for fusion imaging of US and MRI will be performed. Automatic Imaging fusion of ultrasonography and MRI
Arm Title
Manual registration arm
Arm Type
Active Comparator
Arm Description
Manual registration for fusion imaging of US and MRI will be performed. Manual Imaging fusion of ultrasonography and MRI
Intervention Type
Device
Intervention Name(s)
Automatic Imaging fusion of ultrasonography and MRI
Intervention Description
Radiofrequency ablation for hepatic malignancies will be performed with automatic registration registration. Except the imaging registration, all other procedures for RF ablation is same.
Intervention Type
Device
Intervention Name(s)
Manual Imaging fusion of ultrasonography and MRI
Intervention Description
Radiofrequency ablation for hepatic malignancies will be performed with manual registration registration. Except the imaging registration, all other procedures for RF ablation is same.
Primary Outcome Measure Information:
Title
Registration accuracy
Description
Accuracy of imaging fusion (US and MRI)
Time Frame
Immediately after RF ablation
Secondary Outcome Measure Information:
Title
Technical success
Description
Completeness of tumor ablation
Time Frame
Within 48 hours after RF ablation
Title
Technical effectiveness
Description
Completeness of tumor ablation
Time Frame
One month after RF ablation
Title
Registration time
Description
Time required for registration
Time Frame
Within 48 hours after RF ablation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joon-Il Choi
Organizational Affiliation
Seoul St. Mary's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul St.Mary's Hospital
City
Seoul
ZIP/Postal Code
06591
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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