99mTc-Labeled FAPI SPECT Imaging in Pulmonary Fibrosis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Diagnostic accuracy
研究概览
简要总结
This prospective study will investigate the potential usefulness of 99mTc labeled FAPI SPECT/CT in the diagnosis, treatment response assessment, and follow-up of pulmonary fibrosis.
详细描述
Idiopathic pulmonary fibrosis refers to a specific form of chronic fibrous interstitial pneumonia that occurs spontaneously, limited to the lung, and shows features of usual interstitial pneumonia on high resolution computed tomography and histological examination. Radionuclide labeled FAPI has been developed as a new tracer for tumor and inflammatory lesions imaging. Recent studies have shown that FAPI PET/CT imaging is a promising new imaging method for pulmonary fibrosis. HFAPI is obtained by conjugating 99mTc-chelator moiety (6-hydrazinonicotinamide, HYNIC) with FAP targeting moiety. The aim of this study is to investigate the location and extent of 99mTc labeled FAPI tracer (99mTc-HFAPI) in normal and fibrotic lung tissue of patients with pulmonary fibrosis, and to explore the clinical significance of 99mTc-HFAPI SPECT/CT in the diagnosis, treatment response evaluation and follow-up of pulmonary fibrosis.
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
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •suspected or confirmed pulmonary fibrosis patients;
- •signed written consent.
排除标准
- •pregnancy;
- •breastfeeding;
- •known allergy against FAPI
- •any medical conditions that are considered by the investigator to be likely to seriously interfere with study compliance
研究组 & 干预措施
Patients diagnosed with pulmonary fibrosis
Patients of Pulmonary Fibrosis SPECT/CT imaging: The patients were subcutaneously injected with 99mTc-HFAPI and underwent SPECT/CT imaging.
干预措施: 99mTc-HFAPI (Drug)
结局指标
主要结局
Diagnostic accuracy
时间窗: through study completion, an average of 1.5 years
Qualitative and semi-quantitative analysis (T/N ratio of lesions and adjacent normal tissue, and early and late imaging) of 99mTc-HFAPI SPECT/CT for pulmonary fibrosis
次要结局
未报告次要终点