Recruiting

PCCT & Ultrasound

Sponsor:

Duke University

Code:

NCT07495332

Conditions

Fatty Liver

Hepatic Steatosis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Photon-counting CT (PCCT)

Ultrasound

Magnetic Resonance Imaging (MRI)

Study Details

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.

Conditions

Fatty Liver

Hepatic Steatosis

Study ID

NCT07495332

Start date

Mar 27, 2026

Status verified date

Mar, 2026

Completion date

May, 2027

Anticipated

Primary completion date

May, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

45 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

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.

active comparator: MRI

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

active comparator: Ultrasound

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

Interventions

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.

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.

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.

Primary outcome measure

  • Sensitivity of CT-FF (computed tomography fat fraction) [ Time Frame: 1 day to 14 days ]
  • Specificity of CT-FF (computed tomography fat fraction) [ Time Frame: 1 day to 14 days ]

Central Contacts and Locations

Central contacts

Mustafa Bashir, MD

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

Locations

Duke University Medical Center

Recruiting

Durham, North Carolina, United States, 27710

Contacts

Elisabeth Luck CCRC

919-684-7752mary.luck@duke.edu

Principal Investigator:

Mustafa Bashir, MD

More Information

Sponsor

Duke University

Last update posted

Apr 3, 2026

Last verified

Mar, 2026

Keywords

  • Fatty Liver
  • Liver Fibrosis
  • Hepatic steatosis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Duke University on 2026-04-03.