Status:
RECRUITING
Fluctuational Imaging for the Diagnosis of Hepatic Hemangioma: A Multicenter, Prospective Study
Lead Sponsor:
Yonsei University
Conditions:
Hemangioma
Eligibility:
All Genders
19+ years
Brief Summary
\[Background and Rationale\] Hepatic hemangioma is the most common benign tumor of the liver, with a reported prevalence of up to 20% in the general population. On B-mode ultrasonography, a typical he...
Detailed Description
\[Study Population and Sample Size\] This is an exploratory, prospective, multicenter study. A predefined sample size is not required. With an estimated enrollment of approximately 100 cases per insti...
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Key Trial Info
Start Date :
January 2 2026
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT07418294
Start Date
January 2 2026
End Date
December 31 2026
Last Update
February 18 2026
Active Locations (1)
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1
Severance hospital, Yonsei university college of medicine
Seoul, Seodaemun-gu, South Korea, 03722