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

NCT ID: NCT02985034

Last Updated: 2016-12-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

77 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-10-31

Study Completion Date

2016-10-31

Brief Summary

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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

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Conditions

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HCC Liver Tumor

Keywords

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HCC RFA Liver tumor

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jeong Min Lee

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jeong Min Lee, MD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

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Seoul National University Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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SNUH-2010-1412

Identifier Type: -

Identifier Source: org_study_id