Positron Emission Tomography (PET) Imaging of Reactive Oxygen and Nitrogen Species: Human Observation of Retention and Safety of [18F]-Fluoroedaravone
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 10
- 主要终点
- Evaluate safety of [18F]fluoroedaravone administration in up to 10 human subjects.
研究概览
简要总结
This first-in-human research study will test the safety of a new PET imaging tracer called[18F]fluoroedaravone ([18F]FEDV) in healthy adults. Participants will receive one injection of the tracer and undergo several PET/CT scans over about 3 hours. Researchers will collect blood and urine samples, check vital signs and heart activity (ECGs), and ask participants about any symptoms to learn how the tracer moves through and leaves the body and to monitor for side effects. Information from this study will help researchers develop this imaging tracer for future studies of oxidative stress, a process linked to inflammation and long-term health problems in cancer survivors and other diseases.
Primary Objective(s):
• Generate safety data and calculate biodistribution and organ dosimetry in healthy adult volunteers following [18F]fluoroedaravone intravenous administration.
详细描述
Oxidative stress occurs when the body produces more reactive oxygen and nitrogen species than it can remove. Oxidative stress has been linked to inflammation, tissue injury, and a variety of diseases. Researchers believe it may also contribute to long-term health problems experienced by some survivors of childhood cancer, including cognitive difficulties. However, there are currently no clinically available imaging methods that directly measure oxidative stress in living people.
This first-in-human study will evaluate a new investigational PET imaging tracer called[18F]fluoroedaravone ([18F]FEDV). The tracer is designed to detect and measure oxidative stress in the body using positron emission tomography (PET) imaging. Before this tracer can be studied in patient populations, it is important to determine its safety, biodistribution, and radiation dosimetry in healthy adults.
Approximately 10 healthy adult volunteers will be enrolled. Each participant will receive a single intravenous injection of [18F]FEDV followed by a series of PET/CT imaging scans over approximately 3 hours. Researchers will evaluate how the tracer distributes throughout the body, how long it remains in different organs and tissues, and how it is cleared from the body. These data will be used to estimate radiation exposure and identify organs that receive the highest tracer uptake.
Safety will be assessed through monitoring of adverse events, vital signs, electrocardiograms (ECGs), symptom questionnaires, and laboratory testing. Blood and urine samples will be collected before and after tracer administration to assess safety and to better understand the metabolism and elimination of the tracer. Participants will return for a follow-up visit 48 to 96 hours after tracer administration for additional safety evaluations.
The main purpose of this study is to determine whether[18F]FEDV is safe to use in healthy adults and to learn how it moves through and leaves the body after injection. Information from this study will help researchers use this imaging tracer in future studies of oxidative stress in cancer survivors and other health conditions. The long-term goal is to develop a PET imaging tool that can help doctors and researchers better measure oxidative stress in the body.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 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
- •Healthy volunteers, 18-75 years of age.
- •Informed consent signed by participant according to the guidelines of the institutional review board.
- •Female participants of childbearing age must not be lactating due to theoretical potential harm to the infant from exposure to radiation.
排除标准
- •Participant has been treated for cancer.
- •Participant has experienced a stroke.
- •Participant has history of seizures.
- •Participant has been diagnosed with a neurodegenerative or neurodevelopmental disorder.
- •Participant has been diagnosed with a psychiatric disorder such as bipolar or schizophrenia.
- •Participant has been diagnosed or is suspected to have had a traumatic brain injury or concussion (TBI) within the last year.
- •Participant has known disease of the lung, liver, kidneys, gastrointestinal tract, bones/joints, or known immune suppression or autoimmune disease likely to have active inflammation (examples to exclude: Crohn's disease, COPD, asthma)
- •Participant has prosthetic or indwelling device(s), including IUD, currently, or has had one in the past 60 days.
- •Participant has undergone any procedure of an internal organ.
- •Participant is pregnant or breastfeeding.
- •Estimated glomerular filtration rate < 45 ml/minute/1.73m2
- •Participants actively taking anti-inflammatory medication or have a condition requiring them to take anti-inflammatory medication (e.g. NSAIDs or steroids).
- •Participant has any condition that would, in the opinion of the investigator, place the subject at an unacceptable risk of injury or render the subject unable to meet the requirements of the protocol, including being unable to tolerate the PET scan procedures.
- •Inability or unwillingness of research participant or legal guardian/representative to give written informed consent.
研究组 & 干预措施
Treatment - [18F]Fluoroedaravone PET Imaging
Healthy adult volunteers receive a single intravenous injection of [18F]fluoroedaravone ([18F]FEDV), followed by serial whole-body PET/CT imaging evaluations. Participants also undergo blood collection, urine collection, vital sign monitoring, ECG assessments, symptom questionnaires, and a follow-up safety visit 48 to 96 hours after tracer administration.
干预措施: [18F]Fluoroedaravone ([18F]FEDV) (Drug)
Treatment - [18F]Fluoroedaravone PET Imaging
Healthy adult volunteers receive a single intravenous injection of [18F]fluoroedaravone ([18F]FEDV), followed by serial whole-body PET/CT imaging evaluations. Participants also undergo blood collection, urine collection, vital sign monitoring, ECG assessments, symptom questionnaires, and a follow-up safety visit 48 to 96 hours after tracer administration.
干预措施: PET/CT Imaging (Procedure)
结局指标
主要结局
Evaluate safety of [18F]fluoroedaravone administration in up to 10 human subjects.
时间窗: Baseline at study entry and within 4 days following PET/CT.
Safety will be assessed by the number and percentage of patients with adverse events following \[18F\]fluoroedaravone administration. Adverse events will be categorized by the FDA's Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials.
Evaluate the biodistribution of [18F]fluoroedaravone in up to 10 human subjects.
时间窗: Through study completion, with an average of 3 months post-PET/CT.
Calculate the absorbed dose of \[18F\]fluoroedaravone in normal organs.
次要结局
未报告次要终点