Molecular Imaging Probes to Inform Heterogeneity in Idiopathic Pulmonary Fibrosis
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Correlate quantitative PET measures of lung inflammation with [F-18]FDG and [F-18]DPA-714 to pulmonary function tests.
研究概览
简要总结
The purpose of the study is to see if imaging with fluorine-18 Fluorodeoxyglucose ([18F] FDG) and fluorine-18 Displacement Per Atom ([18F]DPA-714) using positron emission tomography and computed tomography (PET/CT) will show lung inflammation and fibrosis in patients diagnosed with idiopathic pulmonary fibrosis (IPF). This study may help physicians and researchers better understand how best to treat patients with IPF in the future.
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
入排标准
- 年龄范围
- 40 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 40-85 years old.
- •A diagnosis of IPF that fulfills American Thoracic Society (ATS) / European Respiratory Society (ERS) 2018 consensus criteria within 5 years.
- •Ability and willingness to give informed consent and adhere to study requirements.
- •Ratio of forced expiratory volume in 1 second to forced vital capacity (FEV1/FVC) >0.
- •High or mixed affinity binder for TSPO ligands based on genotyping for single-nucleotide polymorphism (SNP)rs6971.
排除标准
- •Acute exacerbation of IPF within <30 days
- •Diagnosis of Diabetes Mellitus (Type 1 or Type 2).
- •Diagnoses of current infection by clinical or microbial assessments.
- •Treatment for >14 days within the preceding month with >20 mg. prednisone (or equivalent) or any treatment during the last month with a cellular immunosuppressant.
- •Subjects with prior radiation therapy to the thorax.
- •Women who are pregnant, or who are breastfeeding. IPF is a disease of older adults, and male predominant, so this will not be a frequent consideration.
- •Severe cardiovascular disease, defined as any of the following within the preceding 12 weeks: acute myocardial infarction or unstable angina, a coronary revascularization procedure, or stroke.
- •Subjects with known liver disease.
- •Diagnosis of any active cancer with the exception of basal cell carcinoma of skin.
- •Low affinity binder for TSPO ligands based on genotyping for SNP rs
- •Active cigarette smoking or vaping
研究组 & 干预措施
PET/CT using PET ligands [18F]FDG and [18F]DPA-714
干预措施: PET/CT using PET ligands [F-18]FDG and [F-18]DPA-714 (Drug)
结局指标
主要结局
Correlate quantitative PET measures of lung inflammation with [F-18]FDG and [F-18]DPA-714 to pulmonary function tests.
时间窗: screening to 48 hours post 2nd imaging visit.
次要结局
未报告次要终点
研究者
Deepak Prabataram Kalbi
Assistant Professor
University of Alabama at Birmingham