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

HCC Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02985034
• Other study ID #: SNUH-2010-1412
• Status: Completed
• Phase: N/A
• First received: December 5, 2016
• Last updated: December 5, 2016
• Start date: October 2010
• Est. completion date: October 2016

Study information

• Verified date: December 2016
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 77
• Est. completion date: October 2016
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• HCC
• Liver Neoplasms
• Liver Tumor

Intervention

Procedure:
• RFA
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.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Local tumor progression (LTP)	5-year-LTP rate in HCC between sufficient and insufficient ablative margin groups (according to visual assessment and registration software-assisted assessment)	60 months	No
Secondary	technique efficacy	Rate of absence of viable tumor on 1-months follow-up CT scan.	1 month after RFA	No
Secondary	immediate technical success on visual assessment	technical success of RFA on post-RFA CT using side-by-side comparison of pre-RFA MRI and post-RFA CT	1 day after RFA	No
Secondary	immediate technical success on registration-software assessment	technical success of RFA on post-RFA CT using registration-software assessment between pre-RFA MRI and post-RFA CT	1 day after RFA	No