Siemens Biomarker Multi-modality
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Sensitivity of CT-FF (computed tomography fat fraction)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Contraindications to any of the required imaging examinations
- •BMI > 45 (based on MRI scanner capacity)
研究组 & 干预措施
Photon Counting CT (PCCT)
Participants will get a regular CT scan on the PCCT scanner, plus a few extra pictures just for the study.
干预措施: Photon-counting CT (PCCT) (Diagnostic Test)
MRI
Participants will get an MRI, either on the same day as the PCCT scan or a different day, whichever is preferred.
干预措施: Magnetic Resonance Imaging (MRI) (Diagnostic Test)
Ultrasound
Participants will get an ultrasound on the same day as the MRI.
干预措施: Ultrasound (Diagnostic Test)
结局指标
主要结局
Sensitivity of CT-FF (computed tomography fat fraction)
时间窗: 1 day to 14 days
The percentage of patients with hepatic steatosis by MRI-PDFF who have positive CT-PDFF.
Specificity of CT-FF (computed tomography fat fraction)
时间窗: 1 day to 14 days
The percentage of patients without hepatic steatosis by MRI-PDFF who have negative CT-PDFF.
次要结局
- Sensitivity of Ultrasound-Derived Fat Fraction (UDFF)(1 day to 14 days)
- Specificity of Ultrasound-Derived Fat Fraction (UDFF)(1 day to 14 days)