ElastographyNCT06463223
HIBOC = Hepatic Imaging Biomarkers in Obese Children
An observational study of Elastography and Shear Wave Elastography, run by Sahlgrenska University Hospital at 1 site in Sweden.
Trial summary
The goal of this prospective, diagnostic observational study is to learn about how imaging based markers for components of liver disease appear in children with obesity. It aims to determine whether the imaging markers (ultrasound and MRI) for liver disease can be tools to improve diagnostics for liver affection in… Read more about this study
- Who is it for?
- Ages 9 to 14 years
- Conditions the study is for
- Elastography, Shear Wave Elastography, Shear Wave Dispersion
- How many people
- 300 participants
- Where
- 1 siteSweden
- Study dates
- 1 Feb 2025to Dec 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 14 years
- All sexes
- No healthy volunteers
- Child
Study population: Prospectively, children referred for obesity to one of several Pediatric and Youth Clinics in the Västra Götaland region will be included. Inclusion in the study will occur via the respective clinic according to the following criteria: age 9 to 14 years, new visit or follow-up annual visit at the respective clinic, BMI of 30 or more, obesity for more than 1 year at the time of inclusion. Exclusion criteria include: difficulties in understanding written/oral information, comorbidity that can affect the liver (e.g., medications or diseases with known liver impact), claustrophobia (applies to the MRI cohort), implants or other factors that prevent MRI (applies to the MRI cohort). We aim to include 300 children
Who may be able to join
- Age 9 to 14 years
- New referral/first visit or follow-up annual visit at each healthcare center (Child and adolescent oriented centers) included
- BMI 30 or more
- Obesity >1 year at inclusion
Who cannot join
- Difficulty understanding written/oral information
- Comorbidities that can affect the liver (e.g., medications or diseases with known liver impact)
- Claustrophobia (applies to the MRI cohort)
- Implants or other factors that prevent MRI (applies to the MRI cohort)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site
Department of Radiology, Queen Silvias Children´s Hospital, Institution of Clinical Sciences
Gothenburg, Västra Götaland County, 41650
About this study
Official title: Imaging-based Biomarkers for Liver Disease in Children With Obesity-a Longitudinal Study
The goal of this prospective, diagnostic observational study is to learn about how imaging based markers for components of liver disease appear in children with obesity. It aims to determine whether the imaging markers (ultrasound and MRI) for liver disease can be tools to improve diagnostics for liver affection in children with obesity and to ascertain how the markers are related to multiple clinical measures, for example BMI and serology measure, and treatment effects over time.
Read the detailed description
Background Childhood obesity is a global health problem with a prevalence of 10%. Overweight and obesity are strongly associated with metabolic-associated fatty liver disease (MASLD), which includes a continuum of fatty liver, hepatitis, fibrosis, and cancer. Early diagnosis is crucial for reducing morbidity and mortality but requires detailed characterization of the liver, for which invasive biopsies are the gold standard.
New ultrasound-based markers are promising, non-invasive methods for liver characterization; Shear Wave Dispersion (SWD), Shear Wave Elastography (SWE), and Attenuation Imaging (ATI) have been reported as promising for reflecting inflammation, fibrosis, and steatosis in the liver, respectively. Clinical studies are needed to validate the usefulness of these markers, particularly in children.
Purpose The study aims to determine whether imaging markers (ultrasound and MRI) for liver disease can be tools to improve diagnostics for liver affection in children with obesity and to ascertain how the markers are related to multiple clinical measures, for example BMI and serology measures, and treatment effects over time.
Material \& Method This study is a prospective diagnostic observational study, including children (approximately 300) referred for obesity to several Pediatric Clinics in Västra Götaland, Sweden. Inclusion criteria are: age 9-14 years, BMI > 29, obesity > 1 year. Exclusion criteria: comorbidity that can affect the liver. Ultrasound with measurements of the livermarkers SWE, SWD, and ATI will be performed at inclusion and during annual visits over 3 years. SWE, SWD, and ATI will be compared with parameters included in clinical monitoring, such as weight, height, BMI, blood tests, blood pressure, waist circumference, physical activity, screen habits, etc. In a subcohort, estimated 50 children, with obesity-related disease as indication for referral and treatment to Queen Silvias Childrens Hospital, additionally MRI will be performed at inclusion.
Significance Imaging-based liver markers have great potential to improve diagnostics in children with obesity by reflecting liver disease without a biopsy. If these markers can be used to early diagnose liver disease before it becomes manifest, it is a significant gain. Additionally, if it is possible to distinguish between different pathoanatomical phenotypes (fibrosis/inflammation/steatosis) without a biopsy, it is possible to monitor the disease more rigorously, which opens new opportunities to optimize treatment for the individual child.
- Conditions
- Elastography, Shear Wave Elastography, Shear Wave Dispersion, Attenuation Imaging, Child Obesity, Metabolic Disease
- Medical subject headings
- Pediatric Obesity, Metabolic Diseases, Liver Cirrhosis, Disease, Hepatitis, Fatty Liver
What is being measured
The primary outcome is the main question the study is designed to answer.
Attenuation imaging
an ultrasound based measure of steatosis in the liver
Measured: baseline, 1 year, 2 years and 3 years follow up
Shear wave dispersion
an ultrasound based estimation of increased liver viscosity, seen in for example inflammation
Measured: baseline, 1 year, 2 years and 3 years follow up
shear wave dispersion
an ultrasound based measure of liver stiffness as a reflection of liver fibrosis
Measured: baseline, 1 year, 2 years and 3 years follow up
Secondary outcomes (4)
Magnetic Resonance Imaging fat fraction
Estimation of fat content in the liver
Measured: baseline, 1 year, 2 years and 3 years follow up
Magnetic Resonance Imaging elastography
measurement of liver stiffnes on MRI
Measured: Baseline, 1 year,2 years and 3 years follow up
Magnetic Resonance Imaging diffusionbased imaging
Quantitative estimation of viscoelastic tissue properties
Measured: baseline, 1 year, 2 years and 3 years follow up
Magnetic Resonance Imaging relaxometry
Detailed tissue characterization with measurement of fibrosis in the liver
Measured: Baseline, 1 year,2 years and 3 years follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2024
- Study start1 Feb 2025
- Primary completionDec 2029 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ElastographyStudies of the same condition, open and under way.
- More trials run by Sahlgrenska University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sahlgrenska University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hannah Hebelka, Sahlgrenska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06463223
- Sponsor's protocol ID
- 2024-02255-01
- Status last verified
- Sep 2025
- First submitted
- 12 Jun 2024
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Imaging-based Biomarkers for Liver Disease in Children With Obesity-a Longitudinal Study
- ClinicalTrials.gov ID
- NCT06463223
- Acronym / sponsor ID
- 2024-02255-01
- Conditions
- Elastography, Shear Wave Elastography, Shear Wave Dispersion, Attenuation Imaging, Child Obesity, Metabolic Disease
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Sahlgrenska University HospitalUniversity, hospital or other
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- Dec 2029 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 17 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this prospective, diagnostic observational study is to learn about how imaging based markers for components of liver disease appear in children with obesity. It aims to determine whether the imaging markers (ultrasound and MRI) for liver disease can be tools to improve diagnostics for liver affection in children with obesity and to ascertain how the markers are related to multiple clinical measures, for example BMI and serology measure, and treatment effects over time.
Detailed description
Background Childhood obesity is a global health problem with a prevalence of 10%. Overweight and obesity are strongly associated with metabolic-associated fatty liver disease (MASLD), which includes a continuum of fatty liver, hepatitis, fibrosis, and cancer. Early diagnosis is crucial for reducing morbidity and mortality but requires detailed characterization of the liver, for which invasive biopsies are the gold standard.
New ultrasound-based markers are promising, non-invasive methods for liver characterization; Shear Wave Dispersion (SWD), Shear Wave Elastography (SWE), and Attenuation Imaging (ATI) have been reported as promising for reflecting inflammation, fibrosis, and steatosis in the liver, respectively. Clinical studies are needed to validate the usefulness of these markers, particularly in children.
Purpose The study aims to determine whether imaging markers (ultrasound and MRI) for liver disease can be tools to improve diagnostics for liver affection in children with obesity and to ascertain how the markers are related to multiple clinical measures, for example BMI and serology measures, and treatment effects over time.
Material \& Method This study is a prospective diagnostic observational study, including children (approximately 300) referred for obesity to several Pediatric Clinics in Västra Götaland, Sweden. Inclusion criteria are: age 9-14 years, BMI > 29, obesity > 1 year. Exclusion criteria: comorbidity that can affect the liver. Ultrasound with measurements of the livermarkers SWE, SWD, and ATI will be performed at inclusion and during annual visits over 3 years. SWE, SWD, and ATI will be compared with parameters included in clinical monitoring, such as weight, height, BMI, blood tests, blood pressure, waist circumference, physical activity, screen habits, etc. In a subcohort, estimated 50 children, with obesity-related disease as indication for referral and treatment to Queen Silvias Childrens Hospital, additionally MRI will be performed at inclusion.
Significance Imaging-based liver markers have great potential to improve diagnostics in children with obesity by reflecting liver disease without a biopsy. If these markers can be used to early diagnose liver disease before it becomes manifest, it is a significant gain. Additionally, if it is possible to distinguish between different pathoanatomical phenotypes (fibrosis/inflammation/steatosis) without a biopsy, it is possible to monitor the disease more rigorously, which opens new opportunities to optimize treatment for the individual child.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 9 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Prospectively, children referred for obesity to one of several Pediatric and Youth Clinics in the Västra Götaland region will be included. Inclusion in the study will occur via the respective clinic according to the following criteria: age 9 to 14 years, new visit or follow-up annual visit at the respective clinic, BMI of 30 or more, obesity for more than 1 year at the time of inclusion. Exclusion criteria include: difficulties in understanding written/oral information, comorbidity that can affect the liver (e.g., medications or diseases with known liver impact), claustrophobia (applies to the MRI cohort), implants or other factors that prevent MRI (applies to the MRI cohort). We aim to include 300 children
Key inclusion criteria (4 listed)
- Age 9 to 14 years
- New referral/first visit or follow-up annual visit at each healthcare center (Child and adolescent oriented centers) included
- BMI 30 or more
- Obesity >1 year at inclusion
Key exclusion criteria (4 listed)
- Difficulty understanding written/oral information
- Comorbidities that can affect the liver (e.g., medications or diseases with known liver impact)
- Claustrophobia (applies to the MRI cohort)
- Implants or other factors that prevent MRI (applies to the MRI cohort)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Attenuation imaging
Time frame: baseline, 1 year, 2 years and 3 years follow up
an ultrasound based measure of steatosis in the liver
Shear wave dispersion
Time frame: baseline, 1 year, 2 years and 3 years follow up
an ultrasound based estimation of increased liver viscosity, seen in for example inflammation
shear wave dispersion
Time frame: baseline, 1 year, 2 years and 3 years follow up
an ultrasound based measure of liver stiffness as a reflection of liver fibrosis
4 secondary outcomes
Magnetic Resonance Imaging fat fraction
Time frame: baseline, 1 year, 2 years and 3 years follow up
Magnetic Resonance Imaging elastography
Time frame: Baseline, 1 year,2 years and 3 years follow up
Magnetic Resonance Imaging diffusionbased imaging
Time frame: baseline, 1 year, 2 years and 3 years follow up
Magnetic Resonance Imaging relaxometry
Time frame: Baseline, 1 year,2 years and 3 years follow up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Elastography and Shear Wave Elastography, run by Sahlgrenska University Hospital at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 18 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Attenuation imaging (time frame: baseline, 1 year, 2 years and 3 years follow up). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2026.