NCT00413647已完成1 期
A Phase I Study to Evaluate the Safety, Biodistribution and Radiation Dosimetry of CardioPET™ as a PET Tracer for Detection of Coronary Artery Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Change in vital signs. Change in physical examination. Change in ECG. Change in 24-hour Holter. Change in dosimetry (blood and urine)measured at time 0 (immediately folloing injection), 1, 5, 15, 30, 60, and 90 minutes. Adverse event assessment.
研究概览
简要总结
Safety and dosimetry of CardioPET™ will be evaluated in normal healthy volunteers and CAD subjects both male and female between the ages of 50-85. Nine normal controls will undergo repeated whole body imaging for biodistribution and dosimetry estimation. Six other normal healthy subjects will undergo heart imaging only. Six CAD subjects will undergo heart imaging only.
详细描述
CardioPET™ is a modified fatty acid (MFA) that closely resembles naturally-occurring free fatty acids (FFAs) in the human body.
Study Procedures:
Visit 1: Screening - Eligibility determination
Visit 2: Injection and PET Imaging
Visit 3: Follow-up Visit
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
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Normal Healthy Volunteers:
- •Subject must provide written informed consent prior to any study related procedures
- •Subjects must be between the ages of 50 and 85 years of age.
- •Coronary Artery Disease (CAD) subjects:
- •Subjects must provide written informed consent prior to any study related procedures;
- •Subjects must be ≥ 50 and ≤ 85 years of age;
- •Subject must have history of CAD documented by an exercise stress Myocardial Perfusion Imaging (MPI) study within 6 months documenting myocardial infarct without ischemia.
排除标准
- •Normal Healthy Volunteers:
- •Any clinically significant acute or unstable physical or psychological disease based on medical history or screening physical examination
- •Any clinically significant abnormality in the screening laboratory tests or ECG
- •Fasting blood glucose level over 120 mg/dl
- •Any exposure to any investigational drugs with four(4)weeks prior to Visit 1
- •Any exposure to radiopharmaceuticals within four(4)weeks prior to the date of Visit 1
- •Any new prescription medications within four(4)weeks of Visit 1
- •Subject has a Positive(+)Serum and/or Urine Pregnancy Test or is lactating, or the possibility of pregnancy cannot be ruled out prior to dosing. There are standard pregnancy procedures for use of radiopharmaceuticals in research at MGH
- •Coronary Artery Disease (CAD) Subjects:
- •Subject has a Positive (+) Serum and/or Urine Pregnancy Test or is lactating, or the possibility of pregnancy cannot be ruled out prior to dosing;
- •Any clinically significant acute or unstable physical or psychological disease judged by the investigators based on medical history or screening physical examination;
- •Coronary artery bypass graft (CABG) within 1 year;
- •Percutaneous coronary intervention (PCI), with stent placement within three months;
- •Blood pressure over 180/100;
- •Acute changes in ECG;
- •Cardiac ischemia identified by MPI stress test;
- •Recent (within 3 months) cardiac arrest, unstable angina, myocardial infarction, cerebro-vascular accident (CVA), any general anesthesia procedure, any surgical procedures;
- •Any implanted pacemaker or defibrillator use within the last three months;
- •Inability to remain in camera for approximately 60 minutes (Smokers and COPD are included as long as they can breath in PET camera and not taking O2 through nasal canola);
- •History of Diabetes Mellitus;
- •Serum creatinine > 2 mg/dL;
- •All cancer and or chemotherapy patients;
- •Body Mass Index (BMI) is over 35;
- •Any exposure to any investigational drugs or medical device within four (4) weeks prior to imaging study;
- •Any exposure to radiopharmaceuticals within four (4) weeks prior to the date of imaging study;
- •High daily alcohol consumption over 4 alcohol drinks per day.
研究组 & 干预措施
CardioPET
Experimental
干预措施: CardioPET (Drug)
结局指标
主要结局
Change in vital signs. Change in physical examination. Change in ECG. Change in 24-hour Holter. Change in dosimetry (blood and urine)measured at time 0 (immediately folloing injection), 1, 5, 15, 30, 60, and 90 minutes. Adverse event assessment.
时间窗: Screening, Pre-dose, Baseline, Day 1, Pre-, Post-Dose 0, 24-48 hours and 7 days (Adverse events).
Normal healthy volunteers for whole body imaging group and NHV and Coronary Artery Disease (CAD)undergoing cardiac imaging.
次要结局
- Performance characteristics of CardioPET as a PET tracer for myocardial imaging.(0, 1 min, 5 min, 15 min, 30 min, 60 min, and 90 min.)
- Evaluation and optimization of the methods of image acquisition, output processing, display, reconstruction, and imaging data(Baseline, 15 second time frames for first 2 minutes, 1 min. time frame for next 8 min., 2 min frames for remainder of 60 min study.)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
A Phase I Study to Evaluate BFPET as a Potential Myocardial Perfusion Imaging(MPI) Agent for PETCoronary Artery DiseaseNCT00733460Fluoropharma, Inc.12
已完成
1 期
A Phase 1 Trial for Evaluation of the Safety, Pharmacokinetics, and [18F] Radiation Dosimetry of CTT1057Prostate CancerNCT02916537Cancer Targeted Technology20
已完成
1 期
Study Evaluating Safety, Tolerability, Pharmacokinetics and 5 HT1A Receptor OccupancyAlzheimer's DiseaseNCT00499200Wyeth is now a wholly owned subsidiary of Pfizer42
已完成
不适用
Biodistribution and Pathophysiology Study of 11C-para-aminobenzoic AcidRenal ExcretionBacterial InfectionsInflammatory DiseaseOncologic DiseaseNCT05611905Johns Hopkins University13
进行中（未招募）
1 期
Safety, Tolerability, PK and PD of ADX-850 in Participants With HypertensionHypertension,EssentialHypertensionNCT06205628ADARx Pharmaceuticals, Inc.28