Noninvasive Biomarkers of Metabolic Liver Disease 1.1
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 4
- 主要终点
- Different-day, Different-operator Reproducibility Coefficient of Transient Elastography Based Shear Wave Speed Measurements
研究概览
简要总结
NIMBLE is a comprehensive collaborative effort to standardize, compare, validate, and advance the regulatory qualification of imaging and circulating biomarkers to diagnose and stage nonalcoholic steatohepatitis (NASH), and to predict and assess response to therapeutic intervention (https://fnih.org/what-we-do/biomarkers-consortium/programs/nimble). This study focuses on estimating the repeatability and reproducibility of ultrasound elastography-based biomarkers across a range of fibrosis stages.
详细描述
Study 1.1, is a prospective, two-center, short-term cross-sectional study to assess the reproducibility and repeatability of a set of specified ultrasound-based quantitative imaging biomarkers. The primary focus will be on imaging biomarkers of the liver fibrosis component of nonalcoholic fatty liver disease (NAFLD), rather than the steatosis or inflammation component. The rationale is that the fibrosis component is linked most closely to survival and other clinical outcomes. Study 1.1 will also collect data to explore vendor- or device-specific investigational biomarkers on other components of NAFLD such as steatosis and possibly inflammation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
盲法说明
Study participants will not be randomized to individual treatment groups. To ensure a uniform distribution of scanner combinations, participants will follow a block-allocation pattern with different scanner combinations for different participants, however, patients and operators will not be blinded to ultrasound scanners being used.
All efforts will be made to keep ultrasound operators blinded to clinical and laboratory data, however, it is not believed that this will significantly affect the ultrasound acquisition. The Visit 2 operator will be asked to not review the Visit 1 exam results.
Central analysts will be blinded to key clinical and laboratory findings to minimize potential bias. Blinding of the central analysts will be outlined in a separate Image Review Charter.
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
- •Adult (age ≥ 18 years)
- •Known or suspected NAFLD based on prior biopsy ≤ 36 months consistent with NAFLD OR
- •Abnormal ALT (>30 U/L for men, > 19 U/L for women) without other common causes such as HCV, HBV, AND meets criteria within 36 months for ATP III criteria (2005 revision) for metabolic syndrome with any 3 of the 5:
- •Waist circumference (WC) > 102 cm (M) or > 88 cm (F)
- •Fasting glucose ≥ 100 mg/dL or Rx
- •TG≥150mg/dLorRx
- •SBP > 130 mmHg
- •DBP>85mmHg or Rx
- •Able and willing to participate, including maintaining steady-state: physical activity, alcohol use, medications
- •Classifiable into one of the following enrollment categories by FIB-4 (ALT, AST, platelets, date of birth) collected at screening visit if not available already within 3 months prior:
- •Low likelihood of advanced fibrosis: FIB-4 ≤ 1.3 (about one-third of enrolled participants, minimum 8, maximum 18), Intermediate likelihood of advanced fibrosis: 1.3 < FIB-4 < 2.67 (about one-third of enrolled participants, minimum 8, maximum 18), High likelihood of advanced fibrosis: FIB-4 ≥ 2.67: (about one-third of enrolled participants, minimum 8, maximum 18)
排除标准
- •Liver disease other than NAFLD
- •Excess alcohol consumption (≥ 2 units/day for women and ≥ 3 units/day for men)
- •Current diagnosis of drug induced liver injury
- •Receiving drug or placebo in treatment trial now or within 30 days
- •Weight loss or gain of ≥ 5 kg in prior 3 months
- •Other factors that in the judgment of the principal investigator might preclude study completion
- •Women who state they are pregnant. Women who state they are pregnant will be excluded in an abundance of caution, since pregnancy might increase intra-abdominal pressure which in turn might affect the assessment of the different-day reproducibility coefficient of ultrasound and VCTE measurements. Women who state they might be pregnant will be required to do a urine pregnancy test to establish eligibility.
- •Patients with active implants such as pacemakers or defibrillators or any other contraindication to ultrasound or VCTE scanning.
结局指标
主要结局
Different-day, Different-operator Reproducibility Coefficient of Transient Elastography Based Shear Wave Speed Measurements
时间窗: (2 visits, baseline + up to 7days). Outcome measure will be assessed after pooling all measurements from all study subjects.
The same research subject undergoes multiple shear wave elastography measurements (measured in m/s) on multiple ultrasound imaging devices and transient elastography at two visits (baseline + up to 7 days) with different operators. Elastographic measurements are recorded. The median shear wave velocity value (in m/s) is computed for each ultrasound imaging device and is displayed by the transient elastography device. The ultrasound machine measurements are pooled and the pooled different day-different operator reproducibility coefficient for the group of ultrasound machines is computed. The reproducibility coefficient for transient elastography is computed separately. The pooled different-day, different-operator reproducibility coefficient of transient elastography measurements (in m/s unit), is reported in the outcome measure data table section.
Evaluation of Pooled Different-day, Different-operator Reproducibility of Shear Wave Speed Measurements
时间窗: (2 visits, baseline + up to 7 days). Outcome measure will be assessed after pooling measurements from all study subjects.
The same research subject undergoes multiple shear wave elastography measurements (measured in m/s) on multiple ultrasound imaging devices and transient elastography at two visits (baseline + up to 7 days) with different operators. Elastographic measurements are recorded. The median shear wave velocity value (in m/s) is computed for each ultrasound imaging device and is displayed by the transient elastography device. The ultrasound machine measurements are pooled and the pooled different day-different operator reproducibility coefficient for the group of ultrasound machines is computed. The reproducibility coefficient for transient elastography is computed separately. The pooled different-day, different-operator reproducibility coefficient of ultrasound measurements of shear wave speed, is reported in the outcome measure data table section.
次要结局
- Evaluation of Pooled Same-day, Same-operator Repeatability of Shear Wave Speed (SWS)((2 visits, baseline + up to 7days). Outcome measure will be assessed after pooling measurements from all study subjects.)
- Evaluation of Same-day, Same-operator Repeatability of Transient Elastography((2 visits, baseline + up to 7days). Outcome measure will be assessed after pooling all measurements from all study subjects.)
- Evaluation of Pooled Different-scanner, Same-day Reproducibility of Shear Wave Elastography.((2 visits, baseline + up to 7days). Outcome measure will be assessed after pooling all measurements from all study subjects.)
研究者
Anthony Samir
Radiologist, Service Chief, Body Ultrasound Imaging Services
Massachusetts General Hospital