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

NCT02705118 | Completed

• 1 other identifier: KC15DNSI0039
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatocellular Carcinoma

Keywords

radiofrequency ablation; image fusion

Outcome Measures

Primary Outcomes (1)

• Registration accuracy

  Accuracy of imaging fusion (US and MRI)

  Immediately after RF ablation

Secondary Outcomes (3)

• Technical success

  Within 48 hours after RF ablation

• Technical effectiveness

  One month after RF ablation

• Registration time

  Within 48 hours after RF ablation

Study Arms (2)

Automatic registration arm

EXPERIMENTAL

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

Manual registration arm

ACTIVE COMPARATOR

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

Automatic Imaging fusion of ultrasonography and MRI 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.

Automatic registration arm

Manual Imaging fusion of ultrasonography and MRI 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.

Manual registration arm

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• JOON-IL CHOI: lead

Study Sites (1)

Seoul St.Mary's Hospital

Seoul, 06591, South Korea

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Joon-Il Choi

  Seoul St. Mary's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: December 15, 2015
• First Posted: March 10, 2016
• Study Start: December 1, 2015
• Primary Completion: March 31, 2017
• Study Completion: March 31, 2017
• Last Updated: May 25, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)