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

NCT ID: NCT02705118

Last Updated: 2017-05-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-31

Study Completion Date

2017-03-31

Brief Summary

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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

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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.

Conditions

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Hepatocellular Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Automatic registration arm

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

Automatic Imaging fusion of ultrasonography and MRI

Group Type EXPERIMENTAL

Automatic Imaging fusion of ultrasonography and MRI

Intervention Type DEVICE

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

Manual registration arm

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

Manual Imaging fusion of ultrasonography and MRI

Group Type ACTIVE_COMPARATOR

Manual Imaging fusion of ultrasonography and MRI

Intervention Type DEVICE

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

Interventions

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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.

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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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)
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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JOON-IL CHOI

OTHER

Sponsor Role lead

Responsible Party

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JOON-IL CHOI

Associate professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Joon-Il Choi

Role: PRINCIPAL_INVESTIGATOR

Seoul St. Mary's Hospital

Locations

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Seoul St.Mary's Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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KC15DNSI0039

Identifier Type: -

Identifier Source: org_study_id

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