68Ga-BMV101 PET/CT in Patients With Idiopathic Pulmonary Fibrosis
关键词
抽象
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.
日期
| 最后验证: | 05/31/2015 |
| 首次提交: | 06/25/2015 |
| 提交的预估入学人数: | 06/25/2015 |
| 首次发布: | 06/29/2015 |
| 上次提交的更新: | 04/04/2017 |
| 最近更新发布: | 04/06/2017 |
| 实际学习开始日期: | 12/31/2014 |
| 预计主要完成日期: | 11/30/2017 |
| 预计完成日期: | 11/30/2017 |
状况或疾病
干预/治疗
Drug: 68Ga-BMV101 injection and PET/CT scan
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| Experimental: 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. | Drug: 68Ga-BMV101 injection and PET/CT scan 68Ga-BMV101 were intravenously injected into the patients 1 h before the PET/CT scans. |
资格标准
| 有资格学习的年龄 | 18 Years 至 18 Years |
| 有资格学习的性别 | All |
| 接受健康志愿者 | 是 |
| 标准 | Inclusion Criteria: 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. Exclusion Criteria: - 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. |
结果
主要结果指标
1. Visual and semiquantitative assessment of lesions [1 year]
次要成果指标
1. Blood pressure [24 hours]
2. Pulse [24 hours]
3. Respiration frequency [24 hours]
4. Temperature [24 hours]
5. Routine blood test [24 hours]
6. Routine urine test [24 hours]
7. Serum alanine aminotransferase [24 hours]
8. Serum albumin [24 hours]
9. Serum creatinine [24 hours]
10. Adverse events collection [5 days]
