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.

Study Overview

• Status: Recruiting
• Conditions: Fatty Liver; Hepatic Steatosis
• Intervention / Treatment: Diagnostic test: Photon-counting CT (PCCT); Diagnostic test: Magnetic Resonance Imaging (MRI); Diagnostic test: Ultrasound

• Study Type: Interventional
• Enrollment (Estimated): 45
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mustafa Bashir, MD; Phone Number: 919-684-7366; Email: mustafa.bashir@duke.edu

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Recruiting
      • Duke University Medical Center
      • Contact: Elisabeth Luck CCRC; Phone Number: 919-684-7752; Email: mary.luck@duke.edu
      • Principal Investigator: Mustafa Bashir, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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); 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.
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); 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.
Active Comparator: Ultrasound; Participants will get an ultrasound on the same day as the MRI.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity of CT-FF (computed tomography fat fraction)	The percentage of patients with hepatic steatosis by MRI-PDFF who have positive CT-PDFF.	1 day to 14 days
Specificity of CT-FF (computed tomography fat fraction)	The percentage of patients without hepatic steatosis by MRI-PDFF who have negative CT-PDFF.	1 day to 14 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity of Ultrasound-Derived Fat Fraction (UDFF)	The percentage of patients with hepatic steatosis by MRI-PDFF who have positive UDFF.	1 day to 14 days
Specificity of Ultrasound-Derived Fat Fraction (UDFF)	The percentage of patients without hepatic steatosis by MRI-PDFF who have negative UDFF.	1 day to 14 days

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: Siemens Healthineers AG
• Investigators: Principal Investigator: Mustafa Bashir, MD, Duke University

Study record dates

Study Major Dates

• Study Start (Actual): March 27, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027

Study Registration Dates

• First Submitted: March 21, 2026
• First Submitted That Met QC Criteria: March 21, 2026
• First Posted (Actual): March 27, 2026

Study Record Updates

• Last Update Posted (Actual): April 3, 2026
• Last Update Submitted That Met QC Criteria: April 2, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Hepatic steatosis; Fatty Liver; Liver Fibrosis
• Additional Relevant MeSH Terms: Pathologic Processes; Digestive System Diseases; Liver Diseases; Fibrosis; Pathological Conditions, Signs and Symptoms; Fatty Liver; Liver Cirrhosis; Diagnostic Techniques and Procedures; Diagnosis; Tomography; Diagnostic Imaging; Magnetic Resonance Imaging; Ultrasonography
• Other Study ID Numbers: Pro00118520

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No