Safety and Diagnostic Performance of 68Ga-BMV101 PET/CT in Patients With Idiopathic Pulmonary Fibrosis
试验速览
- 阶段
- 早期 1 期
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Visual and semiquantitative assessment of lesions
研究概览
简要总结
Inflammation mediated by macrophage infiltration plays a vital role in a diverse range of physiological conditions. In particular, recent evidence suggests this type of macrophage response is important for the disease pathology of pulmonary fibrosis. Because cysteine cathepsins are proteases that are highly expressed in antigen presenting cells such as macrophages, they serve as promising biomarkers. Employing non-invasive imaging agents 68Ga-BMV101 that specifically recognize cysteine proteases in immune cells has the potential to not only aid early detection but also significantly aid efforts to monitor progression and patient response to therapy.
详细描述
For interests in clinical translation of 68Ga-BMV101, an open-label dynamic whole-body PET/CT study was designed to investigate safety and diagnostic performance of 68Ga-BMV101 in patients with idiopathic pulmonary fibrosis (IPF). A single dose of nearly 111 MBq 68Ga-BMV101 will be intravenously injected into healthy volunteers and patients with suspected IPF. Visual and semiquantitative method will be used to assess the PET/CT images. Changes of blood pressure, pulse, respiration, temperature, routine blood and urine tests, serum alanine aminotransferase, albumin, and creatinine, and any adverse events will be collected from the volunteers. Adverse events will also be observed in the patients.
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 IPF.
- •The diagnosis of IPF is based on The Centres for Disease Control and Prevention (CDC) criteria for diagnosing IPF. 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-BMV101 injection and PET/CT scan
The patients were intravenously injected with 68Ga-BMV101 and underwent PET/CT scan 1 h and 2.5 h after that.
干预措施: 68Ga-BMV101 (Drug)
结局指标
主要结局
Visual and semiquantitative assessment of lesions
时间窗: 1 year
Visual analysis will be performed by consensus reading by at least 3 experienced nuclear medicine physician. 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.
次要结局
- Blood pressure(24 hours)
- Temperature(24 hours)
- Routine blood test(24 hours)
- Serum alanine aminotransferase(24 hours)
- Respiration frequency(24 hours)
- Serum creatinine(24 hours)
- Adverse events collection(5 days)
- Pulse(24 hours)
- Serum albumin(24 hours)
- Routine urine test(24 hours)