Clinical trial NCT06095479: Ultrasound Liver Fat Quantification on Pediatric Patients
Official title: Ultrasound Liver Fat Quantification on Pediatric Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Non-Alcoholic Fatty Liver Disease
Lead sponsor: Philips (China) Investment CO., LTD
Sponsor class: INDUSTRY
Collaborators: name: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
First posted: 2023-10-23
Enrollment: 90
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This prospective study aims to recruit pediatric patients with confirmed or suspected non-alcoholic fatty liver disease (NAFLD) / non-alcoholic steatosis hepatitis (NASH) and who are eligible for standard ultrasound and MRI examinations. All subjects will undergo a 2D ultrasound scan and MRI examination. Approximately 108 subjects will be enrolled, targeting at 90 completing the study.

Detailed description: This prospective study aims to recruit pediatric patients with confirmed or suspected non-alcoholic fatty liver disease (NAFLD) / non-alcoholic steatosis hepatitis (NASH) and who are eligible for standard ultrasound and MRI examinations. All subjects will undergo a 2D ultrasound scan and MRI examination. Approximately 108 subjects will be enrolled, targeting at 90 completing the study.

To assess the correlation between the quantitative ultrasound biomarkers, i.e., HRIQ, AttenQ and ElastQ, and the liver fat content percentage measured by MRI proton density fat fraction (MRI-PDFF) on pediatric patients, in order to evaluate the technical feasibility of using HRIQ, AttenQ and ElastQ to quantify liver fat content for pediatric patients.

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.

Primary outcomes:
measure: Rate of HRIQ, AttenQ and ElastQ, and the liver fat content percentage measured by MRI
timeFrame: up to 28 months
Secondary outcomes:
measure: The concentration of robustness of the investigational LFQ software in the clinical settings
timeFrame: up to 28 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Xinhua Hospital affiliated to Shanghai Jiao Tong University School of Medicine
Study officials:
References: