Safety Margin Assessment After RFA Using the Registration of Pre-ablation MRI and Post-ablation CT

Completed

• Conditions: HCC; Liver Tumor

• Registration Number: NCT02985034
• Lead Sponsor: Seoul National University Hospital

Brief Summary

Magnetic resonance imaging (MRI) has been widely used for small liver lesion detection and characterization. In patients who undergo RFA, MRI is often performed before RFA, whereas immediate technical success is usually assessed by CT. Conventional visual assessment of two modalities may be more challenging than being anticipated, because acquisition position, respiration, and spatial resolution differ between the two. Therefore, the study purpose is to evaluate the results of software-assisted ablative margin assessment using registration of different pre-and post-RFA modalities compared with the conventional method of side-by-side MRI-CT comparison in patients with HCCs.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10
• Primary Completion: 2011-09
• Study Completion: 2016-10
• Status Verified: 2016-12
• Study First Submitted: 2016-12-05
• Study First Submitted QC: 2016-12-05
• Last Update Submitted: 2016-12-05
• Study First Posted: 2016-12-07
• Last Update Posted: 2016-12-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 77

Inclusion Criteria

• patients (≥ 18 years) who were referred to our radiology department for liver tumor RFA
• patients who had liver MR images of sufficient quality for pre-RFA evaluation within 30 days before RFA
• patients with 1-3 tumors (<5 cm)

Exclusion Criteria

• Child-Pugh class C
• any uncorrected coagulopathy
• hypersensitivity to iodine or other reasons that prevented the performance of post-RFA contrast-enhanced CT

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Local tumor progression (LTP)	60 months	5-year-LTP rate in HCC between sufficient and insufficient ablative margin groups (according to visual assessment and registration software-assisted assessment)

Secondary Outcome Measures

Name	Time	Method
technique efficacy	1 month after RFA	Rate of absence of viable tumor on 1-months follow-up CT scan.
immediate technical success on visual assessment	1 day after RFA	technical success of RFA on post-RFA CT using side-by-side comparison of pre-RFA MRI and post-RFA CT
immediate technical success on registration-software assessment	1 day after RFA	technical success of RFA on post-RFA CT using registration-software assessment between pre-RFA MRI and post-RFA CT

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of