Ignite Creation Date:
2024-05-06 @ 7:40 PM
Last Modification Date:
2024-10-26 @ 3:11 PM
Study NCT ID:
NCT06095479
Status:
RECRUITING
Last Update Posted:
2023-10-23
First Post:
2023-10-12
Brief Title:
Ultrasound Liver Fat Quantification on Pediatric Patients
Sponsor:
Philips China Investment CO LTD
Organization:
Philips China Investment CO LTD
Study Overview
Official Title:
Ultrasound Liver Fat Quantification on Pediatric Patients
Status:
RECRUITING
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 ie 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
To assess the correlation between the quantitative ultrasound biomarkers ie 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None