Fluctuational ultrasound imaging to help diagnose liver hemangioma
Fluctuational Imaging for the Diagnosis of Hepatic Hemangioma: A Multicenter, Prospective Study
This project tests whether a special ultrasound method called fluctuational imaging can help doctors identify liver hemangiomas in adults who have focal liver lesions of 1 cm or larger.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 400 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Yonsei University Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Seoul, Seodaemun-gu) |
| Trial ID | NCT07418294 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults aged 19 or older with a focal liver lesion measuring 1 cm or larger on ultrasound who can hold their breath for at least 5 seconds and who will have a definitive diagnosis within one month.
Not a fit: Patients with lesions under 1 cm, poor ultrasound image quality, inability to hold their breath, or without a definitive diagnosis within one month are unlikely to benefit from FLI.
Why it matters
Potential benefit: If successful, FLI could help noninvasively identify hemangiomas on ultrasound and reduce the need for additional contrast CT or MRI.
How similar studies have performed: Early work (e.g., Kobayashi et al. 2021) described the 'fluttering sign' on ultrasound, but the technique has only limited preliminary evidence and has not been widely validated.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Seoul, Seodaemun-gu
- Severance hospital, Yonsei university college of medicine — Seoul, Seodaemun-gu, South Korea (Recruiting)
Study contacts
- Principal investigator: Seung-seob Kim, Professor — Severance Hospital, Yonsei University College of Medicine
- Study coordinator: Seung-seob Kim, Professor
- Email: k2s0127@yuhs.ac
- Phone: 82) 10-2600-0127
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.