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OpenTrials
Completed

NCT Number: NCT02705118

Evaluation of Performance of Automatic Fusion for Radiofrequency Ablation of Hepatocellular Carcinoma

Fusion imaging of US and MRI is very helpful for interventional procedure such as radiofrequency ablation in liver. However, manual registration of US and magnetic resonance (MR) imaging is somewhat time-consuming and difficult for less-experienced physicians. Recently, automatic registration function was developed to help the fusion of US and CT/MRI imaging. The purpose of this trial is to compare the registration time and accuracy of manual registration system and automatic registration system.

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Key information

Conditions

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

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul St.Mary's Hospital

Seoul, 06591, South Korea

About this study

  • Patients will be randomized and assigned.
  • For automatic registration group, automatic image fusion will be done by RS80A US unit and RF ablation will be performed. Image fusion time will be measured.
  • For manual registration group, manual image fusion will be done by LOGIQ-E9 US unit and RF ablation will be performed. Image fusion time will be measured.
  • After radiofrequency (RF) ablation, immediate, contrast enhanced CT will be performed to evaluate technical success and complications 4) Accuracy of registration will be measured by home-made software using 3D techniques.
  • After one month, technical effectiveness will be evaluated by contrast enhanced CT 6) F/U of CT images will be obtained until one year after RF ablation with a interval of 1-3 months.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • More than 40-years old
  • Patients with hepatic malignancy who will underwent radiofrequency ablation

Exclusion criteria

  • Not using fusion imaging (CT guidance or fluoroscopic guidance)

Treatment and study plan

Automatic Imaging fusion of ultrasonography and MRI

Device

Radiofrequency ablation for hepatic malignancies will be performed with automatic registration registration. Except the imaging registration, all other procedures for RF ablation is same.

Manual Imaging fusion of ultrasonography and MRI

Device

Radiofrequency ablation for hepatic malignancies will be performed with manual registration registration. Except the imaging registration, all other procedures for RF ablation is same.

Primary outcomes

  1. Registration accuracy

    Time frame: Immediately after RF ablation

    Accuracy of imaging fusion (US and MRI)

Secondary outcomes

  1. Technical success

    Time frame: Within 48 hours after RF ablation

    Completeness of tumor ablation

  2. Technical effectiveness

    Time frame: One month after RF ablation

    Completeness of tumor ablation

  3. Registration time

    Time frame: Within 48 hours after RF ablation

    Time required for registration

Sponsors and collaborators

Lead sponsor

JOON-IL CHOI

Other

Registry information

Official study title

Evaluation of Performance of S-fusion for Radiofrequency Ablation of Hepatocellular Carcinoma: A Randomized, Prospective Study

Acronym: FAME-US

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Mar 10, 2016
Registry last updated
May 25, 2017

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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