Fatty Liver, Hepatic Steatosis
Conditions
Keywords
Fatty Liver, Liver Fibrosis, Hepatic steatosis
Brief 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. 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_TESTPhoton-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_TESTUltrasound
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_TESTMagnetic 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.
Sponsors
Duke University
Siemens Healthineers AG
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity of CT-FF (computed tomography fat fraction) | 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) | 1 day to 14 days | The percentage of patients without hepatic steatosis by MRI-PDFF who have negative CT-PDFF. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity of Ultrasound-Derived Fat Fraction (UDFF) | 1 day to 14 days | The percentage of patients with hepatic steatosis by MRI-PDFF who have positive UDFF. |
| Specificity of Ultrasound-Derived Fat Fraction (UDFF) | 1 day to 14 days | The percentage of patients without hepatic steatosis by MRI-PDFF who have negative UDFF. |
Countries
United States
Contacts
CONTACTMustafa Bashir, MD
PRINCIPAL_INVESTIGATORMustafa Bashir, MD
Duke University
Outcome results
None listed