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Clinical Trials/NCT02985034
NCT02985034
Completed
Not Applicable

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

Seoul National University Hospital1 site in 1 country77 target enrollmentOctober 2010
ConditionsHCCLiver Tumor

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
HCC
Sponsor
Seoul National University Hospital
Enrollment
77
Locations
1
Primary Endpoint
Local tumor progression (LTP)
Status
Completed
Last Updated
9 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 2010
End Date
October 2016
Last Updated
9 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Jeong Min Lee

Professor

Seoul National University Hospital

Eligibility Criteria

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

Outcomes

Primary Outcomes

Local tumor progression (LTP)

Time Frame: 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 Outcomes

  • 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)

Study Sites (1)

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