An interventional study of automatic CT/MRI-US fusion system guided radiofrequency ablation in Hepatocellular Carcinoma, sponsored by Seoul National University Hospital. Completed. Open to participants aged 20 Years to 90 Years. Per ClinicalTrials.gov, last updated 2021-04-14.
Sponsored by Seoul National University Hospital · Not applicable, Interventional, and Treatment
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.
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.
3,182 studies on the registry are indexed under Carcinoma, Hepatocellular; 954 are open to participants now.
This study's enrollment of 139 is above the median of 55 across 2,298 interventional studies indexed under Carcinoma, Hepatocellular.
Browse Carcinoma, Hepatocellular studies →Seoul National University Hospital is the lead sponsor of 1,860 studies on the registry; 275 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
patients undergo routine conventional feasibility planning ultrasound, and clinical decision of RFA feasibility is made based on conventional planning ultrasound. Then additional planning ultrasound using automatic CT/US fusion technique is immediately performed by the same operator, and clinical decision is made based on fusion imaging.
Procedure: automatic CT/MRI-US fusion system guided radiofrequency ablation
automatic CT/MRI-US fusion system guided radiofrequency ablation
Technical success rate of the fusion process
Absolute technical success rate of the fusion process
Time frame: Immediately after fusion process
Technical success rate of the overall RFA procedure
Absolute technical success rate of the overall RFA compared to literature
Time frame: immediately after RFA procedure
Rate of complete ablation of the tumor after 1 month clinical follow up
Rate of complete ablation of the tumor after 1 month clinical follow up compared to literature
Time frame: 1 month after the RFA procedure
Local tumor progression rate
Local tumor progression rate after follow up compared to literature
Time frame: During post procedural follow up to 5 years
Tumor visibility before and after the fusion process
Tumor visibility recorded by a 4-scale scoring system. Comparison between pre- and post- fusion process.
Time frame: 10 minutes after finishing planning USG
Technical feasibility before and after the fusion process
Technical feasibility recorded by a 4-scale scoring system. Comparison between pre- and post- fusion process.
Time frame: 10 minutes after finishing planning USG
Safety of the approach route before and after the fusion process
Safety of the approach route recorded by a 4-scale scoring system. Comparison between pre- and post- fusion process.
Time frame: 10 minutes after finishing planning USG
No study locations are listed for this record.
Plan to share: No
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This study is completed, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.
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Seoul National University Hospital