Development of FAPI PET as a Non-invasive Biomarker of Pulmonary Fibrogenesis
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change in FAPI uptake
研究概览
简要总结
The goal of this clinical trial is to gain more information about how fibroblast activation protein inhibitor (FAPI) binds to a certain type of cells in fibrotic lung tissue and how this information can be used to better diagnose and track fibrotic lung disease activity.
Participants will undergo up to 4 PET/MRI scans using the FAPI radiotracer.
详细描述
Researchers aim to develop a non-invasive PET/MRI imaging tool using FAPI as a PET radiotracer and MRI to assess the presence and extent of fibrogenesis (the process that leads to fibrosis and scarring) in the lungs.
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 or older
- •Able and willing to provide informed consent
- •Group A: Clinically evaluated for need for initiation of new treatment (in patients not on current treatment), initiation of change in current treatment, or addition of new treatment (to any current treatment) in the setting of fibrotic hypersensitivity pneumonitis (HSP) or idiopathic pulmonary fibrosis (IPF), per standard of clinical care at UW Health.
- •Group B: Clinically evaluated and stable without need for initiation of new treatment (in patients not on current treatment), initiation of change in current treatment, nor addition of new treatment (to any current treatment) in the setting of fibrotic hypersensitivity pneu-monitis (HSP) or idiopathic pulmonary fibrosis (IPF), per standard of clinical care at UW Health.
- •Crossover (Group B to A): Enrolled in Group B and found at next SOC clinical follow up to have need for initiation of new treatment (in patients not on current treatment), initiation of change in current treatment, or addition of new treatment (to any current treatment) in the setting of fibrotic hypersensitivity pneumonitis (HSP) or idiopathic pulmonary fibrosis (IPF), per standard of clinical care at UW Health.
- •Willing and able to undergo PET/MRI.
- •Participants requiring intravenous (IV) conscious sedation for imaging are not eligible; participants requiring mild, oral anxiolytics for the clinical MRI will be allowed to participate as long as the following criteria are met:
- •The subject has their own prescription for the medication
- •Informed consent is obtained prior to the self-administration of this medication
- •They come to the research visit with a driver
排除标准
- •Participant is unable or unwilling to provide informed consent
- •Participant is pregnant
- •Participant with contraindication(s) to or inability to undergo PET/MRI
- •Participants with contraindications to GBCA will be asked to undergo research imaging without the use of contrast. Contraindications may be severe kidney disease or previously documented GFR < 30 ml/min/1.73 m2
研究组 & 干预措施
Group A - 3 scans
Participants undergo three PET/MRI scans using the FAPI radiotracer. They will have 3 research visits, and each visit may last up to 2.5 hours.
干预措施: FAPI tracer (Drug)
Group A - 3 scans
Participants undergo three PET/MRI scans using the FAPI radiotracer. They will have 3 research visits, and each visit may last up to 2.5 hours.
干预措施: PET/MRI (Device)
Group B - 2 scans
Participants undergo two PET/MRI scans using the FAPI radiotracer. They will have 2 research visits, and each visit may last up to 2.5 hours.
干预措施: FAPI tracer (Drug)
Group B - 2 scans
Participants undergo two PET/MRI scans using the FAPI radiotracer. They will have 2 research visits, and each visit may last up to 2.5 hours.
干预措施: PET/MRI (Device)
Group B Crossover
Participants undergo two additional PET/MRI scans using the FAPI radiotracer. They will have 2 additional research visits, and each visit may last up to 2.5 hours.
干预措施: FAPI tracer (Drug)
Group B Crossover
Participants undergo two additional PET/MRI scans using the FAPI radiotracer. They will have 2 additional research visits, and each visit may last up to 2.5 hours.
干预措施: PET/MRI (Device)
结局指标
主要结局
Change in FAPI uptake
时间窗: Baseline to 6 months
FAPI uptake of fibrotic lesions as measured by Standardized Uptake Value (SUV). SUV quantifies the tracer uptake, helping to differentiate between normal and abnormal tissues and assess the extent of tumor activity.
次要结局
未报告次要终点