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

NCT02985034 | Completed DMC

• 1 other identifier: SNUH-2010-1412
• Study Type: observational
• Target: 77
• Locations: 1 country
• Sites: 1

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.

Conditions

HCC; Liver Tumor

Keywords

HCC; RFA; Liver tumor

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• technique efficacy

  1 month after RFA

• immediate technical success on visual assessment

  1 day after RFA

• immediate technical success on registration-software assessment

  1 day after RFA

Interventions

RFA PROCEDURE

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with liver tumor and referred to Radiology for RFA.

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, 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

• Jeong Min Lee, MD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 5, 2016
• First Posted: December 7, 2016
• Study Start: October 1, 2010
• Primary Completion: September 1, 2011
• Study Completion: October 1, 2016
• Last Updated: December 7, 2016

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)