62 Participants Needed

Ultrasound for Fatty Liver Disease

(DeepUSFF Trial)

Recruiting at 1 trial location
JM
EJ
Overseen ByEun Jung Choi, RN
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Seoul National University Hospital
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve how doctors measure liver fat in individuals with metabolic dysfunction-associated steatotic liver disease (MASLD), often linked to being overweight. Researchers will compare a new ultrasound method, DeepUSFF, to MRI scans to determine which is more effective at measuring liver fat. Suitable candidates for this trial include those advised by a doctor that they might have MASLD and require further imaging tests, have a BMI of 25 or higher, or plan to donate part of their liver and need pre-surgery scans. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance diagnostic methods for liver health.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this ultrasound technique is safe for liver fat quantification?

Research shows that the DeepUSFF treatment is easy for people to handle. Previous studies have found that ultrasound methods like DeepUSFF are safe. Participants in these studies did not report any major side effects or problems. The procedure uses ultrasound to check liver fat, which is non-invasive and similar to a regular ultrasound. This makes it generally safe and painless. DeepUSFF has been tested on patients with possible liver issues, and no major safety concerns have emerged.12345

Why are researchers excited about this trial?

Researchers are excited about the trial for the Quantitative Ultrasound Fat Fraction Assessment because it offers a new, non-invasive way to measure liver fat that could be simpler and more accessible than current methods. Traditional options like liver biopsy are invasive and MRI can be expensive and less available. This ultrasound method uses a specialized technique, DeepUSFF, to precisely quantify liver fat in just 10-15 minutes, potentially making it easier for more patients to be evaluated for fatty liver disease without discomfort or lengthy procedures. The hope is to provide a quicker, safer, and more cost-effective diagnostic tool for managing this condition.

What evidence suggests that this ultrasound technique is effective for diagnosing fatty liver disease?

Studies have shown that DeepUSFF, a special type of ultrasound, can accurately measure liver fat. It closely matches MRI-PDFF, the current best method for assessing liver fat. This trial will have all participants undergo both DeepUSFF and MRI-PDFF to directly compare these liver fat quantification methods. Research indicates that DeepUSFF diagnoses fatty liver disease more effectively than some other ultrasound methods. Therefore, DeepUSFF might be a useful tool for detecting liver fat issues without needing an MRI.13467

Who Is on the Research Team?

JM

Jeong Min Lee, MD

Principal Investigator

Seoul National University Hospital

RG

Richard Gary Barr, MD

Principal Investigator

Northeastern Ohio Radiology Research and Education Fund

Are You a Good Fit for This Trial?

This trial is for individuals with metabolic dysfunction-associated steatotic liver disease (MASLD), which includes conditions like fatty liver and hepatitis. Participants should be suitable for both ultrasound and MRI procedures.

Inclusion Criteria

BMI ≥25 kg/m² or waist circumference >90 cm (male) or >80 cm (female), suggesting high likelihood of fatty liver disease
Understanding and signing informed consent
I am 18 years old or older.
See 2 more

Exclusion Criteria

I have a chronic liver disease confirmed by tests.
Pregnancy
Inability to obtain adequate liver ultrasound imaging: Patient cooperation impossible Inadequate image acquisition as determined by investigator
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Diagnostic Imaging

Participants undergo quantitative ultrasound examination and non-contrast liver MRI for liver fat quantification

1 week
2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after diagnostic imaging

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • DeepUSFF
Trial Overview The study is testing how well a new type of ultrasound, called quantitative ultrasound fat fraction (DeepUSFF), measures liver fat compared to the current standard method using MRI-PDFF.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Quantitative Ultrasound Fat Fraction AssessmentExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Seoul National University Hospital

Lead Sponsor

Trials
1,939
Recruited
6,643,000+

Northeastern Ohio Radiology Research and Education Fund

Collaborator

Trials
3
Recruited
2,300+

Citations

Quantitative Ultrasound(DeepUSFF) vs MRI-PDFF for Liver ...This multicenter prospective study aims to evaluate the correlation between quantitative ultrasound fat fraction (USFF) and MRI-PDFF (Proton ...
Quantitative Ultrasound for Hepatic Steatosis: A Systematic ...Conclusions: UDFF seems to offer a reliable and cost-effective quantitative ultrasound modality. So far, it correlates strongly with MRI-PDFF ...
Quantitative US fat fraction for noninvasive assessment of ...Meanwhile, USFF had good diagnostic performance for hepatic steatosis and was superior to CAP and VHSG. USFF represents a superior method for ...
Quantitative Ultrasound Radiofrequency Data Analysis for ...Quantitative ultrasound radiofrequency data analysis for the assessment of hepatic steatosis in nonalcoholic fatty liver disease using magnetic resonance ...
Development and validation of multivariable quantitative ...This study developed and validated multivariable quantitative ultrasound (QUS) model for diagnosing hepatic steatosis.
Quantitative Ultrasound Assessment of Hepatic SteatosisThis prospective study enrolled a total of 31 patients with clinical suspicion of NAFLD to receive liver fat measurements by quantitative ultrasound and ...
US Quantification of Liver Fat: Past, Present, and FutureThe authors discuss the societal impact of fatty liver disease, summarize the current state of liver fat quantification with CT and MRI,
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Terms of Service·Privacy Policy·Cookies·Security