Actively Recruiting
Fluctuational Imaging for the Diagnosis of Hepatic Hemangioma: A Multicenter, Prospective Study
Led by Yonsei University · Updated on 2026-02-18
400
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Hepatic hemangioma is the most common benign liver tumor, seen in up to 20% of people. Typical ultrasound shows it as a bright lesion, but this is only true in about 70% of cases. Other ultrasound features may help, but often contrast-enhanced CT or MRI is needed for a clear diagnosis. Researchers are studying Fluctuational Imaging (FLI), a new computer-based ultrasound method that measures tiny movements within the lesion, aiming to improve diagnosis accuracy and reduce the need for CT or MRI scans. This exploratory, multicenter study will enroll about 400 adults with liver lesions 1 cm or larger. Participants will undergo FLI ultrasound, and their lesions will be classified as hemangioma or other liver tumors using established standards. Four independent readers will review the FLI results to determine if the lesions show positive fluttering signs. The study will compare FLI positivity between hemangioma and non-hemangioma groups and explore how lesion brightness and depth affect FLI performance. Participants will have a single FLI ultrasound exam, with images anonymized for expert review. The main measurement is the presence of FLI-positive findings during the procedure. Secondary measurements include lesion brightness and depth. The study involves no additional risks beyond routine ultrasound. Results may help reduce unnecessary CT or MRI scans, lowering costs and exposure to radiation or contrast agents. The study expects to complete by the end of 2026.
CONDITIONS
Brief Title
Fluctuational Imaging for the Diagnosis of Hepatic Hemangioma: A Multicenter, Prospective Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 19 years or older
- Presence of a focal hepatic lesion measuring 1 cm or larger on ultrasonography
- Lesion diagnosis established by pathology or lesion-specific imaging reference standards, or expected to be definitively established within 1 month after the FLI examination
- Ability and willingness to provide written informed consent
You will not qualify if you...
- Inability to maintain stable breath-holding for at least 5 seconds during ultrasonography
- Inadequate B-mode ultrasound image quality of the target lesion due to factors such as acoustic shadowing or severe beam attenuation
- Target lesion measuring less than 1 cm on ultrasonography
- Failure to establish a definitive diagnosis within 1 month after the FLI examination
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Within 1 month after screening
Participants undergo Fluctuational Imaging (FLI) on the target hepatic lesion to assist diagnosis.
1 visit (in-person)
Duration - At least 2 years
Participants with hepatic hemangiomas are observed for lesion size stability for at least two years to confirm diagnosis.
Follow-up visits as per routine care
Trial Site Locations
Total: 1 location
1
Severance hospital, Yonsei university college of medicine
Seoul, Seodaemun-gu, South Korea, 03722
Actively Recruiting
Research Team
S
Seung-seob Kim, Professor
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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