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| Name | Class |
|---|---|
| Siemens Healthineers AG | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| MRI | Active Comparator | Participants will get an MRI, either on the same day as the PCCT scan or a different day, whichever is preferred. |
|
| Ultrasound | Active Comparator | Participants will get an ultrasound on the same day as the MRI. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mustafa Bashir, MD | Contact | 919-684-7366 | mustafa.bashir@duke.edu |
| Name | Affiliation | Role |
|---|---|---|
| Mustafa Bashir, MD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Medical Center | Recruiting | Durham | North Carolina | 27710 | United States |
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| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D008103 | Liver Cirrhosis |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D014463 | Ultrasonography |
| D008279 | Magnetic Resonance Imaging |
| ID | Term |
|---|---|
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D014054 | Tomography |
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| 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. |
|
The percentage of patients without hepatic steatosis by MRI-PDFF who have negative UDFF.
| 1 day to 14 days |
| D013568 |
| Pathological Conditions, Signs and Symptoms |