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

Hepatocellular Carcinoma Clinical Trial

— FAME-US  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02705118
• Other study ID #: KC15DNSI0039
• Status: Completed
• Phase: N/A
• First received: December 15, 2015
• Last updated: May 23, 2017
• Start date: December 2015
• Est. completion date: March 31, 2017

Study information

• Verified date: May 2017
• Source: Seoul St. Mary's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: March 31, 2017
• Est. primary completion date: March 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

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.
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Seoul St.Mary's Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
JOON-IL CHOI

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Registration accuracy	Accuracy of imaging fusion (US and MRI)	Immediately after RF ablation
Secondary	Technical success	Completeness of tumor ablation	Within 48 hours after RF ablation
Secondary	Technical effectiveness	Completeness of tumor ablation	One month after RF ablation
Secondary	Registration time	Time required for registration	Within 48 hours after RF ablation