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RecruitingNCT07495332Updated Apr 3, 2026

Siemens Biomarker Multi-modality

An interventional study of Photon-counting CT (PCCT) and Ultrasound in Fatty Liver and Hepatic Steatosis, sponsored by Duke University. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-03.

Sponsored by Duke University · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Started Mar 2026; still recruiting 6 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
45
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Fatty Liver
  • Hepatic Steatosis

Keywords

  • Fatty Liver
  • Liver Fibrosis
  • Hepatic steatosis
03

In context

Fatty Liver

1,451 studies on the registry are indexed under Fatty Liver; 292 are open to participants now.

This study's planned enrollment of 45 is below the median of 60 across 1,003 interventional studies indexed under Fatty Liver.

Browse Fatty Liver studies →

Lead sponsor

Duke University is the lead sponsor of 2,025 studies on the registry; 275 are open to participants now.

Of its 194 completed or terminated interventional studies of FDA-regulated products, 159 (82%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts 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

Exclusion Criteria:

  • Contraindications to any of the required imaging examinations
  • BMI > 45 (based on MRI scanner capacity)
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
45 participants (estimated)

Study arms

  • Active comparator
    Photon Counting CT (PCCT)

    Participants will get a regular CT scan on the PCCT scanner, plus a few extra pictures just for the study.

    Diagnostic Test: Photon-counting CT (PCCT)

  • Active comparator
    MRI

    Participants will get an MRI, either on the same day as the PCCT scan or a different day, whichever is preferred.

    Diagnostic Test: Magnetic Resonance Imaging (MRI)

  • Active comparator
    Ultrasound

    Participants will get an ultrasound on the same day as the MRI.

    Diagnostic Test: Ultrasound

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.

06

What researchers measure

Primary outcomes

  1. Sensitivity of CT-FF (computed tomography fat fraction)

    The percentage of patients with hepatic steatosis by MRI-PDFF who have positive CT-PDFF.

    Time frame: 1 day to 14 days

  2. Specificity of CT-FF (computed tomography fat fraction)

    The percentage of patients without hepatic steatosis by MRI-PDFF who have negative CT-PDFF.

    Time frame: 1 day to 14 days

Secondary outcomes

  1. Sensitivity of Ultrasound-Derived Fat Fraction (UDFF)

    The percentage of patients with hepatic steatosis by MRI-PDFF who have positive UDFF.

    Time frame: 1 day to 14 days

  2. Specificity of Ultrasound-Derived Fat Fraction (UDFF)

    The percentage of patients without hepatic steatosis by MRI-PDFF who have negative UDFF.

    Time frame: 1 day to 14 days

07

Study locations

1 of 1 sites recruiting
  • Duke University Medical Center
    Durham, North Carolina 27710, United States
    • Elisabeth Luck CCRC · Contact · mary.luck@duke.edu · 919-684-7752
    • Mustafa Bashir, MD · Principal investigator
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 3, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07495332
Lead sponsor
Duke University
Collaborators
Siemens Healthineers
Responsible party
Sponsor
First posted
Mar 27, 2026
Start date
Mar 27, 2026
Primary completion
May 2027 (estimated)
Completion
May 2027 (estimated)
Last update
Apr 3, 2026

Study contacts

Mustafa Bashir, MD
Contact
mustafa.bashir@duke.edu
919-684-7366
Mustafa Bashir, MD
principal investigator · Duke University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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