68Ga-FAPI PET/CT to Detect Ongoing Fibroblast Activity in Post-acute COVID-19 With Respiratory Impairment After Hospital Discharge
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Pulmonary SUV values
研究概览
简要总结
The goal of this observational study is to investigate the role fibroblasts play in the persistent respiratory complaints after a COVID-19 infection. Fibroblasts are involved in tissue remodeling and repair by creating scar-tissue (fibrosis) after tissue damage has occurred. The hypothesis is that this process of fibrosis is ongoing in patients with persistent complaints. To evaluate the roll of fibroblasts a new type of scan is used that is capable of imaging active fibroblasts, a 68Ga-FAPI PET/CT scan.
详细描述
Rationale: The pathogenesis of post-acute COVID-19 with respiratory complaints remains unknown. We aim to explore the pulmonary pattern and fibrosis activity in patients with post-acute COVID-19 with respiratory complaints using 68Ga-FAPI Positron Emission Tomography-Computed Tomography (PET/CT) imaging.
Objective
To relate pulmonary fibroblast activity, measured by FAPI-PET/CT at least 3 months after hospital discharge, to interstitial lung abnormalities on high resolution CT (HRCT) at the same time point in post-acute COVID-19 patients with respiratory complaints.
Study design: This is a ZonMw funded single center prospective observational cohort study of post-acute COVID-19 patients with respiratory complaints.
Study population: We will recruit 20 adult patients, all post-ICU or post High-Flow Nasal Oxygen therapy due to there COVID-19 infection, with post-acute COVID-19 and respiratory complaints that will undergo 68Ga-FAPI PET/CT imaging to establish pulmonary fibrosis activity.
Main study parameters/endpoints: To assess the degree of Fibroblast Activation Protein expression on 68Ga-FAPI PET/CT at least 3 months after hospital discharge and to relate this to interstitial lung abnormalities on HRCT at the same time point.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Male patients >18 years and female patients >20 years discharged from hospital after PCR-confirmed COVID-19 infection.
- •Previous ICU or ward admission with high flow nasal oxygen (HFNO) or mechanical ventilation.
- •Persistent respiratory complaints (shortness of breath) at least 3 months after hospital discharge.
排除标准
- •Inability or unwilling to give informed consent.
- •History of claustrophobia or feeling of inability to tolerate supine position for the PET/CT scans.
- •Severe or significant comorbidity, defined as COPD GOLD stage II or higher and/or known interstitial lung disease.
- •Women who are pregnant or breastfeeding.
结局指标
主要结局
Pulmonary SUV values
时间窗: At time of inclusion (T0)
Based on the FAPI PET/CT scan 3-dimensinal volumes of intrest (VOI) are drawn of high FAPI uptake areas (leasions) and non-uptake areas. Using these VOIs SUV values and metabolic active volume (MAV) can be calculated which then can be used to calculate: total lesion FAPI (TL-FAPI), whole-lung FAPI-MAV (wl FAPI-MAV), wlSUVmean and whole lung TL-FAPI (wlTL-FAPI).
次要结局
- HRCT(At time of inclusion (T0))
- 6 minute walking test vs pulmonary SUV values(At time of inclusion (T0))
- Follow-up daily impairments (EQ-5D questionnaire) vs pulmonary SUV values(10 months after T0)
- Follow-up HRCT(10 months after T0)
- DCLO and VC vs pulmonary SUV values(At time of inclusion (T0))
- Cellular phenotypes(At time of inclusion (T0))
- Correlate biomarkers to pulmonary SUV values(At time of inclusion (T0))
- Daily impairments (EQ-5D questionnaire) vs pulmonary SUV values(At time of inclusion (T0))