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New ultrasound trick could replace costly scans for common liver tumors

NCT ID NCT07418294

Diagnosis Sponsor: Yonsei University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests a new computer-based ultrasound technique called Fluctuational Imaging (FLI) to diagnose hepatic hemangiomas, the most common benign liver tumors. Researchers will enroll 400 adults with liver lesions to see if FLI can reliably tell hemangiomas apart from other growths. If it works, FLI could reduce the need for contrast-enhanced CT or MRI scans, lowering healthcare costs and avoiding radiation or contrast risks.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Fluctuational Imaging (FLI) software algorithm
What this could lead to
If successful, FLI could allow doctors to diagnose liver hemangiomas using only ultrasound, avoiding the need for contrast CT or MRI scans.
What could go wrong
This is an early-stage study with 400 participants, and FLI's accuracy may vary depending on the operator or lesion type. It may not work for all liver lesions.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 400 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2026

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

This prospective, multicenter study will enroll adult patients (≥19 years) from four university-affiliated tertiary hospitals in South Korea who have focal hepatic lesions measuring 1 cm or larger on ultrasonography. Eligible participants must have a definitive diagnosis established by pathology or lesion-specific imaging reference standards, or be expected to receive a definitive diagnosis within one month after the FLI examination. The study population will include patients with hepatic hemangiomas as well as a broad spectrum of non-hemangioma hepatic lesions, including both benign and malignant tumors.

Ages

19 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

hemangioma liver hemangioma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hemangioma

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Severance hospital, Yonsei university college of medicine

    RECRUITING

    Seoul, Seodaemun-gu, 03722, South Korea

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