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

NCT02967198 | Completed DMC

• 1 other identifier: 1508-099-695
• Study Type: interventional
• Target: 185
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Liver Mass; Liver Fibroses

Keywords

Fusion; Ablation; Percutaneous biopsy; Shear wave elastography

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Secondary Outcomes (2)

• Rate of tumor visibility on planning USG with/without fusion technique

  10 minutes after finishing planning USG

• Number of patients with safety access route on planning USG with/without fusion technique

  10 minutes after finishing planning USG

Study Arms (1)

CT/US fusion

EXPERIMENTAL

patients undergo routine conventional feasibility planning ultrasound, and clinical decision of percutaneous liver biopsy or RFA feasibility is made based on conventional planning ultrasound. Then additional planning ultrasound using CT/US fusion technique is immediately performed by the same operator, and clinical decision is made based on fusion imaging.

Device: CT/US fusion; Device: ultrasound shear wave elastography

Interventions

CT/US fusion DEVICE

Fusion of pre-procedure cross-sectional imaging (CT or MRI) and real-time USG using registration function of USG device.

CT/US fusion

ultrasound shear wave elastography DEVICE

ultrasound shear wave elastography is performed in S-shear wave scanner according to guidelines of ultrasound elastography.

Also known as: S-shear wave

CT/US fusion

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Liver Cirrhosis

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2016
• First Posted: November 18, 2016
• Study Start: November 1, 2015
• Primary Completion: September 1, 2016
• Study Completion: November 1, 2016
• Last Updated: November 18, 2016

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)