Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 1R01DK135951-01 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
| Virginia Polytechnic Institute and State University | OTHER |
| GE Healthcare | INDUSTRY |
Not provided
Not provided
Not provided
This research study is being conducted to find out more about advanced ultrasound techniques to non-invasively evaluate liver disease in children. The investigators are developing advanced techniques for analyzing ultrasound data and images of the liver, and they will compare it to other established methods used to evaluate the liver, including liver MRI.
The investigators plan to develop and test the advanced analysis techniques using conventional full-size ultrasound machines and, if possible, small handheld devices.
Our goals are:
Our broad long-term objective is to improve the health of children with metabolic dysfunction-associated steatotic liver disease (MASLD), a condition characterized by accumulation of fat in liver cells, by developing and validating accurate, precise, practical, and widely available tools to detect, measure, and monitor liver fat.
Our study aims to develop advanced quantitative ultrasound (QUS) analysis models for use with full-size US and, if possible, inexpensive point-of-care ultrasound (POCUS) systems in children at risk for MASLD to estimate liver fat fraction and classify presence/absence of fatty liver. We anticipate the models will incorporate technical innovations to improve QUS accuracy and efficiency. To develop and test these models, we plan to enroll 120 children who will undergo ultrasound exams using either full-size or POCUS devices. We plan to compare the performance of our QUS models with liver MRI.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort | This is a single arm study in which all participants undergo the same research procedures. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MR exam | Diagnostic Test | Participants will undergo an advanced magnetic resonance (MR) examination of the abdomen and liver. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Development and Evaluation of models for liver fat estimation. | We plan to develop and evaluate models for estimating liver fat fraction and classifying the presence or absence of steatotic liver disease using QUS data. | 5 years |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Children being evaluated for MASLD
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Amy Alba | Contact | 619-543-5228 | amalba@health.ucsd.edu | |
| Gage Tanzman | Contact | g1tanzman@health.ucsd.edu |
| Name | Affiliation | Role |
|---|---|---|
| Jeffrey B Schwimmer, MD | University of California, San Diego | Principal Investigator |
| Claude B Sirlin, MD | University of California, San Diego | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California San Diego | Recruiting | La Jolla | California | 92037 | United States |
Deidentified study data and metadata except imaging data will be deposited in the UC San Diego Library Digital Collections Data Repository.
Start date: 7/1/2025 (anticipated) End date: On or after 7/1/2040 (anticipated)
The data repository (containing deidentified study data and metadata except imaging data) will be made public and will be available from the UC San Diego Digital Collections Data Repository.
Not provided
| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
Not provided
Not provided
Not provided
Not provided
Not provided
Blood plasma, blood serum
| US exam | Diagnostic Test | Participants will undergo an abdominal ultrasound (US) examination using a full-size US system. Some participants may undergo a point-of-care abdominal US exam with a handheld US system, if possible. |
|
| Blood draw | Other | Participants will undergo a blood draw of approximately 25 mL volume. |
|
| Physical measurements | Other | Participants will have their height, weight and waist circumference measured. Vital signs including respiratory frequency, heart rate, temperature, and blood pressure will be measured. |
|
| Questionnaires | Other | Participants will be asked to fill out questionnaires to collect information about their prescribed medications, demographics, medical and surgical histories, prior laboratory results, physical activity and lifestyle measures, and potential alcohol intake (AUDIT questionnaire). |
|
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |