NCT07495332

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
12mo left

Started Mar 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress11%
Mar 2026May 2027

Study Start

First participant enrolled

March 1, 2026

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

March 21, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 27, 2026

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2027

Last Updated

March 27, 2026

Status Verified

March 1, 2026

Enrollment Period

1.2 years

First QC Date

March 21, 2026

Last Update Submit

March 21, 2026

Conditions

Fatty LiverHepatic Steatosis

Keywords

Fatty LiverLiver FibrosisHepatic steatosis

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (2)

  • Sensitivity of Ultrasound-Derived Fat Fraction (UDFF)

    1 day to 14 days

  • Specificity of Ultrasound-Derived Fat Fraction (UDFF)

    1 day to 14 days

Study Arms (3)

Photon Counting CT (PCCT)

ACTIVE COMPARATOR

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)

MRI

ACTIVE COMPARATOR

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)

Ultrasound

ACTIVE COMPARATOR

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

Diagnostic Test: Ultrasound

Interventions

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.

Photon Counting CT (PCCT)
UltrasoundDIAGNOSTIC_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.

Ultrasound
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.

MRI

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

RECRUITING

MeSH Terms

Conditions

Fatty LiverLiver Cirrhosis

Interventions

UltrasonographyMagnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisTomography

Study Officials

  • Mustafa Bashir, MD

    Duke University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mustafa Bashir, MD

CONTACT

919-684-7366mustafa.bashir@duke.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 21, 2026

First Posted

March 27, 2026

Study Start

March 1, 2026

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

May 1, 2027

Last Updated

March 27, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)