Safety and Diagnostic Performance of 68Ga-NOTA-PRGD2 PET/CT in Patients With Lung Injury and Pulmonary Fibrosis
试验速览
- 阶段
- 早期 1 期
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Semiquantitative assessment of lung lesions
研究概览
简要总结
This is an open-label positron emission tomography/computed tomography (PET/CT) study to investigate the diagnostic performance and evaluation efficacy of 68Ga-NOTA-PRGD2 in lung injury (LI) and pulmonary fibrosis (PF) patients. A single dose of nearly 111 MBq 68Ga-NOTA-PRGD2 (≤ 40 µg NOTA-PRGD2) will be intravenously injected into patients with LI/PF. Visual and semiquantitative method will be used to assess the PET/CT images.
详细描述
The αvβ3-integrin is a transmembrane heterodimeric receptor that mediates cell-cell and cell-extracellular matrix adhesion. The αvβ3-integrin plays a pivotal role in promoting and sustaining angiogenesis and fibrosis. Cyclic arginine-glycine-aspartic acid (RGD) peptide is the key integrin recognition motif that can strongly bind to the αvβ3-integrin, which makes the RGD-based peptides hold a promise for imaging and treatment of diseases characterised with angiogenesis and fibrosis including LI and PF.
Animal study in bleomycin induced lung fibrosis showed good uptake ratio of 68Ga-NOTA-PRGD2 in lung vs background. For interests in clinical translation of 68Ga-NOTA-PRGD2, an open-label dynamic whole-body PET/CT study was designed to investigate safety and diagnostic performance of 68Ga-NOTA-PRGD2 in patients with LI or PF.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with idiopathic pulmonary fibrosis
- •Males and females, ≥18 years old.
- •Characteristic clinical signs, symptoms and laboratory tests suggesting the diagnosis of LI/PF.
- •The diagnosis of IPF is based on The Centres for Disease Control and Prevention (CDC) criteria for diagnosing LI/PF. They rely on a combination of clinical, radiological, operative and histological findings, in addition to results of other laboratory tests.
排除标准
- •Females planning to bear a child recently or with childbearing potential.
- •Renal function: serum creatinine >3.0 mg/dL (270 μM/L).
- •Liver function: any hepatic enzyme level more than 5 times upper limit of normal.
- •Known severe allergy or hypersensitivity to IV radiographic contrast.
- •Patients not able to enter the bore of the PET/CT scanner.
- •Inability to lie still for the entire imaging time because of cough, pain, etc.
- •Inability to complete the needed examinations due to severe claustrophobia, radiation phobia, etc.
- •Concurrent severe and/or uncontrolled and/or unstable other medical disease that, in the opinion of the investigator, may significantly interfere with study compliance.
研究组 & 干预措施
68Ga-NOTA-PRGD2 injection & PET/CT scan
The patients were intravenously injected with 68Ga-NOTA-PRGD2 in one dose in nearly 111 MBq and then underwent PET/CT scan 0.5 h later.
干预措施: 68Ga-NOTA-PRGD2 (Drug)
68Ga-NOTA-PRGD2 injection & PET/CT scan
The patients were intravenously injected with 68Ga-NOTA-PRGD2 in one dose in nearly 111 MBq and then underwent PET/CT scan 0.5 h later.
干预措施: PET/CT (Device)
结局指标
主要结局
Semiquantitative assessment of lung lesions
时间窗: 1 year
The semiquantitative analysis will be performed by the same person for all the cases, and the standardized uptake values (SUVs) of lungs will be measured.
Visual assessment of lung lesions
时间窗: 1 year
Visual analysis will be performed by consensus reading by at least 3 experienced nuclear medicine physician.
次要结局
- Routine blood test(24 hours)
- Routine urine test(24 hours)
- Adverse events collection(5 days)
- Serum albumin(24 hours)