FDG-PET Imaging in Young Cystic Fibrosis Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- Kinetic Influx Constant (Ki)
研究概览
简要总结
The purpose of this research is to determine how a person's lungs will uptake [18F]fluorodeoxyglucose (FDG), as measured with positron emission tomography (PET) scanning in young cystic fibrosis (CF) patients.
详细描述
Our recent study in CF adults, supplemented by recent pre-clinical and clinical studies by our group suggests that labeled fluorodeoxyglocose-based positron emission tomography (FDG-PET) imaging may be a valuable quantitative biomarker of lung inflammation. The proposed study would validate our earlier findings, but in a younger patient population. The implications of such a test could be highly significant for both the testing of promising new anti-inflammatory agents and for patient management decisions. To capitalize on this exciting opportunity, the critical next step is to show that we can identify a cohort of young CF patients with both stable lung function and normal (or near normal) FDG-PET imaging studies. Similar patients, then, would become the subjects for a future prospective cohort study to determine if FDG-PET imaging can in fact serve as a predictor of future changes in lung function.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed diagnosis of cystic fibrosis
- •Age 12 to 21 years old, of either gender, any race or ethnicity
- •Stable recent pulmonary status (defined as no new pulmonary symptoms, new antibiotic use, or hospitalization for pulmonary symptoms for at least 1 month).
- •We will permit patients treated with the macrolide antibiotic, azithromycin, to participate in this study. Azithromycin has recently become a virtual standard of care in CF, based on small but reproducible improvements in pulmonary function over 4 months of treatment with this drug. The mechanism of benefit is uncertain, but an anti-inflammatory effect has been suggested. The high prevalence of use means that a study without azithromycin would likely require a wash-out period, without data about the appropriate duration for such a wash-out, or whether inflammatory markers would reverse during that time.
排除标准
- •Failure to obtain informed consent
- •Positive pregnancy test or lactation
- •Currently enrolled in another study involving radioisotopes or an investigational drug
- •Recent (within 30 days of screening) hospitalization for any reason
- •New antibiotic use (within 30 days of screening).
- •Patient incapable of lying still and supine within the PET/computed X-ray tomography (CT) scanner for 90 minutes.
- •Patient incapable of completing other testing procedures (e.g., PFT, induced sputum)
- •Patient with serum glucose greater than 150 mg/dl at time of PET imaging study
- •Patient incapable of fasting for 4 to 6 hrs prior to PET imaging study
研究组 & 干预措施
Stable lung function
* Group S (n = 14) will consist of CF patients, aged 12-21 years old, who underwent FDG-PET with stable lung function during the past 4 years, defined as less than 2% decline per year. There is no therapeutic intervention and FDG-PET scan will be performed in both cohorts.
干预措施: FDG-PET (Diagnostic Test)
Rapidly deteriorating lung function
* Group R (n = 14) will contain CF patients, aged 12-21 years old, who underwent FDG-PET with rapidly deteriorating lung function during the past 4 years with greater than 4% per year decline. There is no therapeutic intervention and FDG-PET scan will be performed in both cohorts.
干预措施: FDG-PET (Diagnostic Test)
结局指标
主要结局
Kinetic Influx Constant (Ki)
时间窗: At the time of FDG scan, 1 to 2 hours
The whole lung kinetic influx constant (Ki) is the primary outcome measure that is derived from the time-activity curves, which are generated from regions of interest placed over the whole lungs. Therefore, a single time-activity curves from each scan is used to derive the Ki.
次要结局
- Sputum Neutrophil Elastase (NE) Concentration(Sample collected within 2-hours of PET scan)
研究者
Thomas Ferkol
Professor of Pediatrics
Washington University School of Medicine