Clinical trial NCT04844112: CT/MR-US Automatic Fusion System in Pre-procedure Planning for Radiofrequency Ablation
Official title: Assessment of the Real-time CT/MR-US Automatic Fusion System Using Vascular Matching in Pre-procedure Planning for Radiofrequency Ablation: Preliminary Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hepatocellular Carcinoma
Keywords: Radiofrequency ablation
Fusion imaging
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Philips Healthcare
First posted: 2021-04-14
Enrollment: 139
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To prospectively evaluate the technical success rate of real-time computed tomography/CT/magnetic resonance imagingMR and -ultrasound (CT/MRI-US) automatic fusion system and the long-term therapeutic efficacy of radiofrequency ablation (RFA) guided by automatic fusion in hepatocellular carcinoma (HCC) patients.

Detailed description: RFA is one of commonly used local therapies for primary or secondary liver tumors. For successful and safe procedure, safe route of electrode and lesion visibility are essential for RFA, and the conditions are usually evaluated on pre-RFA planning ultrasonography (USG). However, RFA is sometimes aborted due to limited sonic window of various cause and challenging identification of small isoechoic tumors or hepatocellular carcinomas among dysplastic nodules . Therefore, precise targeting and assuring safe route would be of clinical importance. In this preliminary study, investigators attempted to determine automatic US and CT/MR fusion technique would be able to improve RFA feasibility in patients with liver tumors.

Eligibility criteria: Inclusion Criteria:

* Pathologic or typical imaging based diagnosis of HCC
* Multiphase CT or MRI within 3 months ahead of procedure
* No evidence of distant metastasis
* No contraindications for conventional RFA procedure in our institute, which are uncontrolled coagulopathy (international standard ratio ≥ 1.6, or platelet \> 50,000), poor cooperation, unfeasible for sedation, portal vein tumor thrombus, tumor number \>4, largest tumor size \> 5cm, and tumors abutting portal vein or bile ducts bigger than segmental branches.

Exclusion Criteria:

* Lack of multiphase CT or MRI withing 3 months ahead of procedure
* RFA planned for palliative purpose
* Diagnosed as non-HCC malignancy
* Right hepatectomy state

Primary outcomes:
measure: Technical success rate of the fusion process
timeFrame: Immediately after fusion process
measure: Technical success rate of the overall RFA procedure
timeFrame: immediately after RFA procedure
measure: Rate of complete ablation of the tumor after 1 month clinical follow up
timeFrame: 1 month after the RFA procedure
Secondary outcomes:
measure: Local tumor progression rate
timeFrame: During post procedural follow up to 5 years
measure: Tumor visibility before and after the fusion process
timeFrame: 10 minutes after finishing planning USG
measure: Technical feasibility before and after the fusion process
timeFrame: 10 minutes after finishing planning USG
measure: Safety of the approach route before and after the fusion process
timeFrame: 10 minutes after finishing planning USG
Other outcomes:
Locations:
Study officials:
affiliation: Professor
name: Jeong Min Lee
role: STUDY_CHAIR
References: