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Completed

NCT Number: NCT02985034

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

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.

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Key information

Conditions

HCC Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Liver Tumor Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Seoul National University Hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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

  1. technique efficacy

    Time frame: 1 month after RFA

    Rate of absence of viable tumor on 1-months follow-up CT scan.

  2. immediate technical success on visual assessment

    Time frame: 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

  3. immediate technical success on registration-software assessment

    Time frame: 1 day after RFA

    technical success of RFA on post-RFA CT using registration-software assessment between pre-RFA MRI and post-RFA CT

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2011
Study completion
2016
First posted
Dec 7, 2016
Registry last updated
Dec 7, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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