Photon-counting CT and ultrasound for detecting liver fat and scarring
Siemens Biomarker Multi-modality
This will test whether a new photon-counting CT plus ultrasound can find liver fat and scarring in adults with fatty liver or liver fibrosis, using MRI as the reference.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 45 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Duke University Academic / other |
| Locations | 1 site (Durham, North Carolina) |
| Trial ID | NCT07495332 on ClinicalTrials.gov |
What this trial studies
This interventional imaging study compares photon-counting CT (PCCT) and ultrasound against MRI to determine how well each modality detects hepatic steatosis and fibrosis. Eligible adults scheduled for a clinically indicated liver CT will receive a PCCT scan with a few additional research images, an MRI (same day or another day by preference), and an ultrasound on the day of the MRI. A hematocrit blood test will be taken if not performed within 24 hours prior to CT. Imaging results from PCCT and ultrasound will be compared to MRI as the reference standard.
Who should consider this trial
Good fit: Adults (18+) with chronic diffuse liver disease, steatotic liver disease, or liver fibrosis who are scheduled for a clinically indicated liver CT and are eligible for MRI and able to consent.
Not a fit: People who cannot undergo MRI or CT (including those with contraindications or with BMI >45) or who do not have liver disease are unlikely to benefit from participating.
Why it matters
Potential benefit: If successful, these methods could make detection of liver fat and scarring faster and more widely available, potentially reducing reliance on MRI.
How similar studies have performed: MRI is the established reference for liver fat and fibrosis, ultrasound has shown variable sensitivity in prior work, and PCCT is a newer technology with promising preliminary data but not yet widely validated for this application.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Durham, North Carolina
- Duke University Medical Center — Durham, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Mustafa Bashir, MD — Duke University
- Study coordinator: Mustafa Bashir, MD
- Email: mustafa.bashir@duke.edu
- Phone: 919-684-7366
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.