Pre-procedure Planning for Liver Biopsy or Radiofrequency Ablation Using CT or MR/US Fusing Imaging

Liver Fibroses Clinical Trial

Official title:

Pre-procedure Planning for Liver Biopsy or Radiofrequency Ablation Using the Automatic Fusion Images of the Registrated 3D CT or MR-US Scans

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02967198
• Other study ID #: 1508-099-695
• Status: Completed
• Phase: N/A
• First received: November 16, 2016
• Last updated: November 16, 2016
• Start date: November 2015
• Est. completion date: November 2016

Study information

• Verified date: November 2016
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether fusion technique of preradiofrequency ablation (RFA) or percutaneous liver biopsy cross-sectional imaging (CT or MR) and real-time ultrasonography would improve feasibility of RFA or liver biopsy in patients with liver tumor in comparison with ultrasonography guidance alone. And assessment of a new point shear-wave elastography method (pSWE, S-shear wave) and compare its accuracy in assessing liver stiffness (LS) with another pSWE technique (ARFI).

Description:

RFA is one of commonly used local therapies for primary or secondary liver tumors. And percutaneous liver biopsy is very important technique to confirm the diagnosis of focal hepatic lesion whether benign or malignancy.

For successful and safe procedure, safe access route and lesion visibility are essential , and the conditions are usually evaluated on pre-procedure planning ultrasonography (USG). However, these procedure 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 US and CT/MR fusion technique would be able to improve RFA or liver biopsy feasibility in patients with liver tumors in comparison with conventional US alone technique.

In addition, to assess intra- and inter-observer reproducibility of a new point shear-wave elastography method (pSWE, S-shear wave) and compare its accuracy in assessing liver stiffness (LS) with another pSWE technique (ARFI).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 185
• Est. completion date: November 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• all conditions should be satisfied for inclusion.

• referred to Radiology in our institution for liver tumor RFA or percutaneous liver biopsy

• available pre-procedure liver CT or liver MR imaging within 6 weeks

Exclusion Criteria:

• any contraindication of liver RFA or percutaneous liver biopsy • any patients who received treatment between pre-RFA imaging and planned RFA.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Liver Cirrhosis
• Liver Fibroses
• Liver Mass

Intervention

Device:
• CT/US fusion
Fusion of pre-procedure cross-sectional imaging (CT or MRI) and real-time USG using registration function of USG device.
• ultrasound shear wave elastography
ultrasound shear wave elastography is performed in S-shear wave scanner according to guidelines of ultrasound elastography.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	RFA or biopsy feasibility rates on planning USG with/without fusion CT/MR and US	comparison of rates of RFA feasibility on conventional planning USG and on fusion planning USG	10 minutes after finishing planning USG	No
Primary	Assessment of a new point shear-wave elastography method (pSWE, S-shear wave)	To assess intra- and inter-observer reproducibility of a new point shear-wave elastography method (pSWE, S-shear wave) and compare its accuracy in assessing liver stiffness (LS) with another pSWE technique (ARFI).	10 minutes after finishing planning USG	No
Secondary	Rate of tumor visibility on planning USG with/without fusion technique	comparison of tumor visibility (or detection) rates on planning USG on conventional planning USG and fusion planning USG	10 minutes after finishing planning USG	No
Secondary	Number of patients with safety access route on planning USG with/without fusion technique	comparison of number of patients with presence/absence of safety access route, and the on two planning USGs	10 minutes after finishing planning USG	No