Imaging of Pathologic Fibrosis Using 68Ga-FAP-2286
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Thomas Hope
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Proportion of participants with treatment-related adverse events
研究概览
简要总结
This is a single arm prospective pilot trial that evaluates the ability of a novel imaging agent (68Ga-FAP-2286) to identify pathologic fibrosis in the setting of hepatic, cardiac and pulmonary fibrosis.
FAP-2286 is a peptide that potently and selectively binds to Fibroblast Activation Protein (FAP). FAP is a transmembrane protein expressed on fibroblasts and has been shown to have higher expression in idiopathic pulmonary fibrosis (IPF), cirrhosis, and cardiac fibrosis.
详细描述
PRIMARY OBJECTIVES:
I. All cohorts: Safety of 68Ga-FAP-2286.
II. Cohort 1: Measured uptake of radiotracer (SUVpeak) in regions of known liver fibrosis.
III. Cohort 2: Measured uptake of radiotracer (SUVpeak) in regions of known pulmonary fibrosis.
IV. Cohort 3: Measured uptake of radiotracer (SUVpeak) in regions of myocardial fibrosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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 >= 18 years.
- •Confirmed pathologic fibrosis in one of the following cohorts
- •Cohort 1: Hepatic fibrosis, based on cirrhosis on imaging or hepatic fibrosis on liver biopsy.
- •Cohort 2: Pulmonary fibrosis, based on CT findings or biopsy of lung parenchyma.
- •Cohort 3: High likelihood of cardiac fibrosis as indicated by known cardiac sarcoidosis or amyloidosis (shown on MRI or Fluorodeoxyglucose (FDG) PET), recent myocardial infarction within the last 30 days (as shown by an elevated troponin), known cardiotoxicity (decreased ejection fraction on systemic therapy), or other known inflammatory or infiltrative disease.
- •Ability to understand a written informed consent document, and the willingness to sign it.
排除标准
- •Unlikely to comply with protocol procedures, restrictions and requirements and judged by the Investigator to be unsuitable for participation.
- •Known pregnancy.
研究组 & 干预措施
Cohort 2: Pulmonary Fibrosis
Patients with pulmonary fibrosis will receive a single administration of 68Ga-FAP-2286 prior to PET imaging.
干预措施: Positron Emission Tomography (PET) (Procedure)
Cohort 1: Liver Fibrosis
Patients with liver fibrosis will receive a single administration of 68Ga-FAP-2286 prior to PET imaging.
干预措施: 68Ga-FAP-2286 (Drug)
Cohort 1: Liver Fibrosis
Patients with liver fibrosis will receive a single administration of 68Ga-FAP-2286 prior to PET imaging.
干预措施: Positron Emission Tomography (PET) (Procedure)
Cohort 2: Pulmonary Fibrosis
Patients with pulmonary fibrosis will receive a single administration of 68Ga-FAP-2286 prior to PET imaging.
干预措施: 68Ga-FAP-2286 (Drug)
Cohort 3: Myocardial Fibrosis
Patients with myocardial fibrosis will receive a single administration of 68Ga-FAP-2286 prior to PET imaging.
干预措施: 68Ga-FAP-2286 (Drug)
Cohort 3: Myocardial Fibrosis
Patients with myocardial fibrosis will receive a single administration of 68Ga-FAP-2286 prior to PET imaging.
干预措施: Positron Emission Tomography (PET) (Procedure)
结局指标
主要结局
Proportion of participants with treatment-related adverse events
时间窗: Up to 31 days
Proportion of participants with Adverse Events, as graded by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0 will be reported.
Median peak standardized uptake value (SUVpeak) in liver region
时间窗: Up to 1 days
The median SUVpeak in regions of known liver fibrosis will be reported with 95% confidence intervals
Median peak standardized uptake value (SUVpeak) in lung region
时间窗: Up to 1 days
The median SUVpeak in regions of known pulmonary fibrosis will be reported with 95% confidence intervals
Median peak standardized uptake value (SUV) in myocardium region
时间窗: Up to 1 days
The median SUVpeak in regions of known myocardial fibrosis will be reported with 95% confidence intervals
次要结局
未报告次要终点
研究者
Thomas Hope
Principal Investigator
University of California, San Francisco