Health TrialsbyHealthPanel

Siemens Biomarker Multi-modality

ConditionsFatty LiverHepatic Steatosis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorDuke University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Contraindications to any of the required imaging examinations

BMI > 45 (based on MRI scanner capacity)

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

45 Participants
are divided into 3 treatment groups
Group A: Photon Counting CT (PCCT)Active comparator 1 intervention
Group B: MRIActive comparator 1 intervention
Group C: UltrasoundActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Sensitivity of CT-FF (computed tomography fat fraction)

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

Time frame
1 day to 14 days
2

Specificity of CT-FF (computed tomography fat fraction)

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

Time frame
1 day to 14 days

Secondary outcomes

1

Sensitivity of Ultrasound-Derived Fat Fraction (UDFF)

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

Time frame
1 day to 14 days
2

Specificity of Ultrasound-Derived Fat Fraction (UDFF)

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

Time frame
1 day to 14 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Duke University

Lead sponsor

Siemens Healthineers AG

Collaborator

Source ClinicalTrials.gov
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