Added Value in Combined Use of Fusion Imaging and Contrast-enhanced Ultrasonography
1 other identifier
interventional
44
1 country
1
Brief Summary
So far, there have been studies showing that the CEUS-grafted technique has added value in biopsy and RFA, but no studies have compared the group using only fusion and the group using CEUS+fusion. Therefore, the additional added value of CEUS will be evaluated by comparing the two groups.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2020
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 2, 2020
CompletedFirst Submitted
Initial submission to the registry
July 20, 2020
CompletedFirst Posted
Study publicly available on registry
July 27, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2022
CompletedApril 8, 2021
April 1, 2021
1.7 years
July 20, 2020
April 6, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Biopsy yield rate
Yield rate
about 2weeks
Secondary Outcomes (5)
Complication rate
about 2days
Tumor visibility on B-mode US
immediately
Evaluation of safety access routes to avoid complication
Time: immediately
Tumor vascularity on CEUS
Time: immediately
Subjective evaluation on the success of the procedure
immediately
Study Arms (1)
CEUS with fusion
EXPERIMENTALControl group: The historic cohort is used to compare the results of the biopsy using fusion only technique from 2013 to 2019.
Interventions
Eligibility Criteria
You may qualify if:
- Patients scheduled for ultrasound biopsy to confirm local liver lesions
- Adults over 18
- Patients who underwent multi-phasic liver CT or MRI within 6 weeks prior to the procedure
- Patients who understand and agree to the explanation and consent form and submit the consent form
You may not qualify if:
- Non-adaptive patients with ultrasound contrast agents (eg acute respiratory failure, heart disease, egg allergy, pregnant women, lactating women)
- Those who have difficulty obtaining proper liver ultrasound images A. Patient cooperation is not possible B. If it is difficult to obtain an image that is appropriate for the researcher's judgment (atrophy of the right lobe of the liver, a bowel is located between the liver and the abdominal wall, etc.)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seoul National University Hospital
Seoul, South Korea
Study Officials
- PRINCIPAL INVESTIGATOR
Jeong Min Lee, MD, PhD
Seoul National University Hospital, Radiology department
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
July 20, 2020
First Posted
July 27, 2020
Study Start
June 2, 2020
Primary Completion
March 1, 2022
Study Completion
December 30, 2022
Last Updated
April 8, 2021
Record last verified: 2021-04
Data Sharing
- IPD Sharing
- Will not share