Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07495332

Siemens Biomarker Multi-modality

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Fatty Liver Digestive System Diseases Fibrosis Hepatic Steatosis Liver Cirrhosis Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location status: Recruiting

Location contact

Elisabeth Luck CCRC

CONTACT

[email protected]

919-684-7752

Mustafa Bashir, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Ultrasound

Diagnostic 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.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

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

    Time frame: 1 day to 14 days

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

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

    Time frame: 1 day to 14 days

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

Study contacts

Contact information is provided by the study sponsor or research team.

Mustafa Bashir, MD

CONTACT

[email protected]

919-684-7366

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • Siemens Healthineers AG

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 27, 2026
Registry last updated
Apr 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.