Fluctuational ultrasound imaging to help diagnose liver hemangioma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Fluctuational imaging (FLI) is a real-time ultrasound technique that looks for continuous motion of tiny bright dots (the 'fluttering sign') within liver lesions. In this multicenter prospective observational design, adults with focal hepatic lesions ≥1 cm undergo FLI and the resulting maps are anonymized and independently read by four blinded readers who classify findings as positive or negative. Lesion diagnoses are confirmed by histopathology or by lesion-specific imaging criteria with stability over time for hemangiomas, and other lesion types require histology or accepted imaging standards. Approximately 400 cases are expected across participating centers to compare FLI findings against these reference standards.

Why it matters

Who can join: the full rules

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.

Where it's running

• Severance hospital, Yonsei university college of medicine
  Seoul, Seodaemun-gu, South Korea Recruiting

Study contacts

• Principal investigator: Seung-seob Kim, Professor — Severance Hospital
• Study coordinator: Seung-seob Kim, Professor
• Email: k2s0127@yuhs.ac
• Phone: 82) 10-2600-0127

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.