Fatty LiverNCT07495332
Siemens Biomarker Multi-modality
A study testing Photon-counting CT (PCCT), Ultrasound and Magnetic Resonance Imaging (MRI) in people with Fatty Liver and Hepatic Steatosis, run by Duke University at 1 site in United States.
Trial summary
The purpose of this study is to see how well Photon Counting CT (PCCT) and ultrasound test results can find fat and scarring in the liver. They will be compared to MRI test results as the reference standard. Participants will get a regular CT scan on the PCCT scanner, plus a few extra pictures just for the study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fatty Liver, Hepatic Steatosis
- What is being tested?
- Photon-counting CT (PCCT), Ultrasound and Magnetic Resonance Imaging (MRI)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Mar 2026to May 2027
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age of 18 years or older
- Has clinically indicated CT schedule including the liver (with contrast or with and without contrast)
- Patient eligible for MR imaging
- History of chronic diffuse liver disease, steatotic liver disease, and/ or liver fibrosis
- Capable of consent
Who cannot join
- Contraindications to any of the required imaging examinations
- BMI > 45 (based on MRI scanner capacity)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Duke University Medical Center
Durham, North Carolina, 27710
Elisabeth Luck CCRC, 919-684-7752, mary.luck@duke.edu
Mustafa Bashir, MD
About this study
The purpose of this study is to see how well Photon Counting CT (PCCT) and ultrasound test results can find fat and scarring in the liver. They will be compared to MRI test results as the reference standard. Participants will get a regular CT scan on the PCCT scanner, plus a few extra pictures just for the study. They will also get an MRI, either on the same day or a different day, whichever is preferred. Participants will get an ultrasound on the same day as the MRI. If they have not had a hematocrit blood test in the past 24 hours, they will also receive one on the day of the CT scan.
- Conditions
- Fatty Liver, Hepatic Steatosis
- Being tested
- Photon-counting CT (PCCT), Ultrasound, Magnetic Resonance Imaging (MRI)
- Keywords
- Fatty Liver, Liver Fibrosis, Hepatic steatosis
- Medical subject headings
- Fatty Liver, Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Photon-counting CT (PCCT)Diagnostic test
Photon-counting computed tomography (PCCT) is a next-generation imaging technology using advanced detectors that directly count individual X-ray photons and measure their energy, rather than integrating total energy like traditional CT.
UltrasoundDiagnostic test
Ultrasound is a safe, radiation-free imaging technique using high-frequency sound waves to visualize soft tissues, organs, and blood flow in real-time.
Magnetic Resonance Imaging (MRI)Diagnostic test
MRI is a noninvasive, radiation-free medical imaging technique that uses powerful magnets and radio waves to generate detailed, high-resolution 3D images of soft tissues, organs, and bones.
| Study group | Role | What they receive |
|---|---|---|
| Photon Counting CT (PCCT) | Active comparator | Participants will get a regular CT scan on the PCCT scanner, plus a few extra pictures just for the study. Receives: Diagnostic Test: Photon-counting CT (PCCT) |
| MRI | Active comparator | Participants will get an MRI, either on the same day as the PCCT scan or a different day, whichever is preferred. Receives: Diagnostic Test: Magnetic Resonance Imaging (MRI) |
| Ultrasound | Active comparator | Participants will get an ultrasound on the same day as the MRI. Receives: Diagnostic Test: Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of CT-FF (computed tomography fat fraction)
The percentage of patients with hepatic steatosis by MRI-PDFF who have positive CT-PDFF.
Measured: 1 day to 14 days
Specificity of CT-FF (computed tomography fat fraction)
The percentage of patients without hepatic steatosis by MRI-PDFF who have negative CT-PDFF.
Measured: 1 day to 14 days
Secondary outcomes (2)
Sensitivity of Ultrasound-Derived Fat Fraction (UDFF)
The percentage of patients with hepatic steatosis by MRI-PDFF who have positive UDFF.
Measured: 1 day to 14 days
Specificity of Ultrasound-Derived Fat Fraction (UDFF)
The percentage of patients without hepatic steatosis by MRI-PDFF who have negative UDFF.
Measured: 1 day to 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start27 Mar 2026
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fatty LiverStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Siemens Healthineers
- Responsible party
- Sponsor
- Investigators
- Mustafa Bashir, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07495332
- Sponsor's protocol ID
- Pro00118520
- Status last verified
- Mar 2026
- First submitted
- 21 Mar 2026
- Last updated
- 3 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Siemens Biomarker Multi-modality
- ClinicalTrials.gov ID
- NCT07495332
- Acronym / sponsor ID
- Pro00118520
- Conditions
- Fatty Liver, Hepatic Steatosis
- Keywords
- Fatty Liver, Liver Fibrosis, Hepatic steatosis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Siemens Healthineers
- Study start
- 27 Mar 2026 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 27 Mar 2026 (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 purpose of this study is to see how well Photon Counting CT (PCCT) and ultrasound test results can find fat and scarring in the liver. They will be compared to MRI test results as the reference standard. Participants will get a regular CT scan on the PCCT scanner, plus a few extra pictures just for the study. They will also get an MRI, either on the same day or a different day, whichever is preferred. Participants will get an ultrasound on the same day as the MRI. If they have not had a hematocrit blood test in the past 24 hours, they will also receive one on the day of the CT scan.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Photon Counting CT (PCCT) | Active comparator | Diagnostic Test: Photon-counting CT (PCCT)Participants will get a regular CT scan on the PCCT scanner, plus a few extra pictures just for the study. |
| MRI | Active comparator | Diagnostic Test: Magnetic Resonance Imaging (MRI)Participants will get an MRI, either on the same day as the PCCT scan or a different day, whichever is preferred. |
| Ultrasound | Active comparator | Diagnostic Test: UltrasoundParticipants will get an ultrasound on the same day as the MRI. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age of 18 years or older
- Has clinically indicated CT schedule including the liver (with contrast or with and without contrast)
- Patient eligible for MR imaging
- History of chronic diffuse liver disease, steatotic liver disease, and/ or liver fibrosis
- Capable of consent
Key exclusion criteria (2 listed)
- Contraindications to any of the required imaging examinations
- BMI > 45 (based on MRI scanner capacity)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Photon-counting CT (PCCT)Photon-counting computed tomography (PCCT) is a next-generation imaging technology using advanced detectors that directly count individual X-ray photons and measure their energy, rather than integrating total energy like traditional CT. | Diagnostic test | Photon Counting CT (PCCT) |
| UltrasoundUltrasound is a safe, radiation-free imaging technique using high-frequency sound waves to visualize soft tissues, organs, and blood flow in real-time. | Diagnostic test | Ultrasound |
| Magnetic Resonance Imaging (MRI)MRI is a noninvasive, radiation-free medical imaging technique that uses powerful magnets and radio waves to generate detailed, high-resolution 3D images of soft tissues, organs, and bones. | Diagnostic test | MRI |
Primary outcome
Sensitivity of CT-FF (computed tomography fat fraction)
Time frame: 1 day to 14 days
The percentage of patients with hepatic steatosis by MRI-PDFF who have positive CT-PDFF.
Specificity of CT-FF (computed tomography fat fraction)
Time frame: 1 day to 14 days
The percentage of patients without hepatic steatosis by MRI-PDFF who have negative CT-PDFF.
2 secondary outcomes
Sensitivity of Ultrasound-Derived Fat Fraction (UDFF)
Time frame: 1 day to 14 days
Specificity of Ultrasound-Derived Fat Fraction (UDFF)
Time frame: 1 day to 14 days
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 3 Apr 2026.
- Individual participant dataSharing planned: No
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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.
Mustafa Bashir, MD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Photon-counting CT (PCCT), Ultrasound and Magnetic Resonance Imaging (MRI) in people with Fatty Liver and Hepatic Steatosis, run by Duke University at 1 site in United States.
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 5 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 3 Apr 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 United States. 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?
Contact Mustafa Bashir, MD (919-684-7366, mustafa.bashir@duke.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity of CT-FF (computed tomography fat fraction) (time frame: 1 day to 14 days). The study lists 2 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 3 Apr 2026.