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

Prospective Evaluation of Local Tumor Progression After Radiofrequency Ablation of Hepatocellular Carcinoma: Effectiveness of Immediate Second-Look Evaluation Using Pre-RFA MRI and Post-RFA CT Registration

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02985034

Enrollment

Registered

2016-12-07

Start date

2010-10-31

Completion date

2016-10-31

Last updated

2016-12-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HCC, Liver Tumor

Keywords

HCC, RFA, Liver tumor

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.

Interventions

PROCEDURERFA

Radiofrequency ablation (RFA) is performed according to routine practice, and then safety margin is assessed by a) visual side-by-side comparison between pre-RFA MRI and post-RFA CT, and b) registration software for two modalities.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026