Siemens Biomarker Multi-modality
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Photon-counting CT (PCCT), Ultrasound, Magnetic Resonance Imaging (MRI).
- Who it may be relevant to
- Registry conditions: Fatty Liver, Hepatic Steatosis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Diagnostic test 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 Ultrasound
Ultrasound 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 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.
Primary outcome measures
- Sensitivity of CT-FF (computed tomography fat fraction) [Time frame: 1 day to 14 days]
- Specificity of CT-FF (computed tomography fat fraction) [Time frame: 1 day to 14 days]
Secondary outcome measures (2)
- 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]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- Contraindications to any of the required imaging examinations
- BMI > 45 (based on MRI scanner capacity)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
United States · 1 center
- Duke University Medical Center — Durham
Identifiers
NCT: NCT07495332 · Pro00118520