Utilizing 18F-fluoroglutamine PET Imaging in Patients With Pulmonary Arterial Hypertension
试验速览
- 阶段
- 早期 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 71
- 试验地点
- 1
- 主要终点
- SUV or image-based threshold of 18F-FGNnon-diseased controls
研究概览
简要总结
Pulmonary arterial hypertension (PAH) is mortal disease affecting the blood vessels of the lung. Despite its morbid prognosis, PAH is often misdiagnosed or ignored, with an average time of 44 months between onset of symptoms to diagnosis and substantial progression of disease severity. Therefore, a pressing need exists to develop non-invasive diagnostic imaging tools, particularly that can detect early disease stages.
Efforts have been made to develop such imaging capabilities through platform development of echocardiography, cardiac MRI, chest computed tomography (CT), and positron emission tomography (PET), among others. While some have demonstrated promise, few have shown a precise ability to offer disease quantifications of the diseased lung and vasculature itself, to detect early stages of disease, and to reflect alterations of the lung, vasculature, and right ventricle that reflect the molecular origins of this disease.
[F-18]FGln has been previously utilized in oncology studies as a non-invasive in vivo imaging biomarker of tumor glutamine flux and metabolism. Our preliminary in vivo pre-clinical rodent studies demonstrated that [F-18]FGln demonstrated increased uptake in diseased pulmonary vessels and the right ventricle in a rodent model of PAH. The proposed research study will provide preliminary evidence of the potential to utilize [F-18]FGln as a non-invasive imaging biomarker of glutamine flux and metabolism across a range of PAH subjects.
详细描述
Objective: Investigators will conduct in-human PET imaging of 18F-fluoroglutamine (18F-FGln) in patients with PAH to compare glutamine uptake to that of controls.
Specific Aim: Utilizing18F-FGln PET imaging to measure pathogenic glutamine uptake in patients with PAH or eiPAH and controls.
Significance: Investigator multi-disciplinary team, comprised of Drs. Chan, Tavakoli, and Mason are already actively collaborating together, and are uniquely positioned to image and quantify glutamine uptake in this special patient population. In doing so, investigators will determine the potential of this [F-18]FGln to serve as a non-invasive imaging biomarker of in vivo glutamine flux and metabolism associated with PAH Investigators are proposing a pilot experiment, Objective: Investigators will conduct in-human PET imaging of 18F-fluoroglutamine (18F-FGln) in patients with PAH to compare glutamine uptake to that of controls.
Specific Aim: Utilizing18F-FGln PET imaging to measure pathogenic glutamine uptake in patients with PAH or eiPAH and controls.
Significance: Investigator multi-disciplinary team, comprised of Drs. Chan, Tavakoli, and Mason are already actively collaborating together, and are uniquely positioned to image and quantify glutamine uptake in this special patient population. In doing so, investigators will determine the potential of this [F-18]FGln to serve as a non-invasive imaging biomarker of in vivo glutamine flux and metabolism associated with PAH
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age between 18-75 years old
- •Confirmed diagnosis of SSc-PAH / SSc-eiPAH/IPAH/ by right heart catheterization. And Scleroderma with no PAH confirmand by echo.
- •Age between 18-75 years old
- •Individuals who are at low risk for current or future cardiovascular or pulmonary symptoms or diseases
排除标准
- •Pregnant/ breast feeding women
- •Children under 18
- •Inability to read and understand the informed consent
- •History of CT contrast allergy
- •Inability to lie down for long period of time
- •Having claustrophobic
- •History of radiation exposure at workplace
- •Consuming more than 2-3 alcoholic drinks a week
- •Working previously in any of the following "cool miner, painter, iron miner, Mill worker, asbestos, insulation/heat resistance materials, sand"
- •Any medical conditions involving the heart or lungs that would make participation in the study unsafe in the opinion of the PI.
- •Pregnant/ breast feeding women
- •Children under 18
- •Inability to read and understand the informed consent
- •History of CT contrast allergy.
- •Inability to lie down for long period of time
- •Having claustrophobic
- •History of radiation exposure at workplace
- •Consuming more than 2-3 alcoholic drinks a week
- •Working previously in any of the following "coal miner, painter, iron miner, Mill worker, asbestos, insulation/heat resistance materials, sand"
- •Any medical conditions involving the heart or lungs or that would make participation in the study unsafe in the opinion of the PI.
- •Family history of Pulmonary Hypertension or Scleroderma
研究组 & 干预措施
18F-FGLN PET Imaging
10.0 mCi of 18F-FGln will be injected intravenously as a slow bolus (20 sec)
干预措施: 18F-FGLN PET Imaging (Diagnostic Test)
18F-FGLN PET Imaging
10.0 mCi of 18F-FGln will be injected intravenously as a slow bolus (20 sec)
干预措施: (18F)FPGLU (Drug)
结局指标
主要结局
SUV or image-based threshold of 18F-FGNnon-diseased controls
时间窗: 90 minutes
Regional \[F-18\] fluoroglutamine (18F-FGN) utilization will be measured as standardized uptake values (SUV) of 18F-FGN in right ventricle wall, left ventricle wall, and perivascular tissue within the lung parenchyma.
次要结局
未报告次要终点
研究者
Stephen Y. Chan
Professor
University of Pittsburgh