Measuring liver fat in children using ultrasound and MRI

Ultrasound Liver Fat Quantification on Pediatric Patients

This study is testing if ultrasound can accurately measure liver fat in children with non-alcoholic fatty liver disease by comparing it to MRI results.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 90 (estimated)
• Ages: 6 Years to 17 Years
• Sex: All
• Sponsor: Philips (China) Investment CO., LTD (industry)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Shanghai)
• Trial ID: NCT06095479 on ClinicalTrials.gov

What this trial studies

This prospective study aims to recruit pediatric patients aged 6 to 18 years with confirmed or suspected non-alcoholic fatty liver disease (NAFLD) or non-alcoholic steatosis hepatitis (NASH). Participants will undergo both a 2D ultrasound scan and an MRI examination to assess liver fat content. The study will evaluate the correlation between ultrasound biomarkers and MRI measurements to determine the feasibility of using ultrasound for liver fat quantification in children. Approximately 108 subjects will be enrolled, with a target of 90 completing the study.

Who should consider this trial

Good fit: Ideal candidates are children aged 6-18 years who are overweight, have Type II diabetes, hypercholesterolemia, or are suspected of having NAFLD/NASH.

Not a fit: Patients with chronic liver diseases or those with evidence of hepatotoxicity may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a non-invasive method for accurately quantifying liver fat in pediatric patients, improving diagnosis and management of NAFLD/NASH.

How similar studies have performed: Other studies have shown promise in using ultrasound for liver fat quantification, but this specific approach in pediatric patients is relatively novel.

Eligibility criteria

Inclusion Criteria:

* Subjects at age of 6-18 years old (≥6 \& \<18) who are able to provide assent to participate and have a parent/legal guardian who is able to provide informed consent for the subject to participate.
* Subject must be eligible for a standard abdominal ultrasound examination and standard non-contrast MRI examination.
* In addition, at least one of the following criteria must also be met:

  * Overweight or obese (BMI-for-age ≥ 85th percentile).
  * Diagnosed with Type II diabetes per standard clinical guidelines.
  * Diagnosed with hypercholesterolemia per standard clinical guidelines.
  * Diagnosed with or clinically suspected of having NAFLD/NASH based on previous medical record, medical imaging, liver biopsy, and/or laboratory testing.

Exclusion Criteria:

* Evidence of hepatotoxicity in the clinical judgment of the investigator.
* History of chronic liver disease (e.g., viral hepatitis, cholestatic hepatitis, or autoimmune liver disease).
* Use of drugs associated with hepatic steatosis1: amiodarone, aethotrexate, nucleoside reverse transcriptase inhibitors (didanosine, stavudine), valproic acid, dexamethasone, tamoxifen, 5-FU-based adjuvant chemotherapy, apo-B inhibitors (mipomersen, lomitapide), tetracycline exceeding 2 g/day and acetylsalicylic acid exceeding 150 mg/kg.

Note: patients taking tetracycline (≤ 2 g/day), acetylsalicylic acid (≤150 mg/kg) are allowed to be enrolled.

* Subjects with hepatic lesions that cannot be excluded from the imaging field during ultrasound LFQ data acquisition.
* Subjects anticipated or planned to undergo any therapeutic intervention during enrollment period that, at discretion of the Investigator, may affect liver fat content (e.g., bariatric surgery, chemotherapy).
* History of previous liver surgery or hepatic implants that, at the discretion of the Investigator, may adversely impact ultrasound or MRI image quality or the subject's eligibility to undergo ultrasound or MRI.
* Subjects with unstable clinical status, late stages of a given disease, or unpredictable clinical course of a given disease.
* Subjects with evidence of COVID-19 or with the substantial risk of COVID-19 infection.

Where this trial is running

Shanghai

• Xinhua Hospital affiliated to Shanghai Jiao Tong University School of Medicine — Shanghai, China (RECRUITING)

Study contacts

• Study coordinator: Yaqing Chen

Conditions: Non-Alcoholic Fatty Liver Disease