Siemens Biomarker Multi-modality

Part of paid clinical trials in Durham, North Carolina.

Sponsor
Duke University
Study ID
NCT07495332
Status
Recruiting
Apply to this trial

Conditions

  • Fatty Liver
  • Hepatic Steatosis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.
  • 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.

Study Details

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.

Key Dates

Start date
Mar 27, 2026
Status verified
Mar 2026
Primary completion
May 31, 2027
Completion
May 31, 2027

Study Design

Enrollment
45 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

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.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Duke University Medical CenterDurhamNorth Carolina27710
Elisabeth Luck CCRC
[email protected]
919-684-7752
Mustafa Bashir, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Durham, NC

By research site
Duke University Medical Center· Durham, NC

Related Studies