Investigation of Inflammation Using [18F]FZTA
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- PET imaging studies of [18F]-FZTA in healthy control participants and participants with Multiple Sclerosis, and measuring the uptake of [18F]-FZTA tracer.
研究概览
简要总结
This study involves a Positron Emission Tomography (PET) scan using a new investigational radioactive tracer, [18F]-FZTA, to detect inflammation in the brain. The tracer will be tested in healthy younger adults and individuals with Multiple Sclerosis.
详细描述
The primary objective of this initial IND study is to evaluate the safety of [18F]-FZTA for PET imaging of S1P1 expression. The study will begin with whole-body PET dosimetry in healthy adult volunteers to determine the safety and safe radiation dose for a single PET scan in humans. Following this, brain and neck imaging will be conducted in both healthy adult control participants and individuals with multiple sclerosis (both male and female) to characterize [18F]-FZTA uptake in the brain. An analysis of the radiolabeled metabolite will also be completed as part of this study.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female, any race
- •Age ≥ 18 years
- •Capable of providing written informed consent for volunteering to undergo research procedures.
- •Healthy volunteer or volunteer with a diagnosis of MS established using the revised McDonald criteria (2017)
排除标准
- •Hypersensitivity to [18F]FZTA or any of its excipients;
- •Contraindications to PET, CT, or MRI (e.g., certain incompatible electronic medical devices, inability to lie still for extended periods) that make it potentially unsafe for the individual to participate.
- •Severe claustrophobia
- •Women who are currently pregnant or breastfeeding
- •Currently undergoing radiation therapy
- •Any condition that, in the opinion of the Sponsor-Investigator or designee could increase risk to the participant, limit the participant's ability to tolerate the research procedures, or interfere with the collection of the data (e.g., renal or liver failure, advanced cancer);
- •Participants who in the last 6 months experienced any of the following cardiovascular conditions or findings in the screening electrocardiogram (ECG): clinically significant cardiac arrhythmias including atrial fibrillation with rapid ventricular response, myocardial infarction, high-grade heart block (type 2 or greater), unstable angina, stroke, transient ischemic attack or decompensated heart failure requiring hospitalization or Class III/IV heart failure;
- •Current or recent (within 12 months prior to screening) participation in research studies involving radioactive agents such that the total research-related radiation dose to the participant in any given year would exceed the limits set forth in the U.S. Code of Federal Regulations (CFR) Title 21 Section 361.1.
研究组 & 干预措施
Healthy participants
Healthy participants will receive a single intravenous bolus injection of 7 ± 20% milliCurie (mCi) of the investigational radiotracer [18F]-FZTA. Participants will then undergo [18F]-FZTA PET scan.
干预措施: [18F] FZTA (Drug)
Participants with Multiple Sclerosis
Participants with Multiple Sclerosis will receive a single intravenous bolus injection of 7 ± 20% milliCurie (mCi) of the investigational radiotracer [18F]-FZTA. Participants will then undergo a brain [18F]-FZTA PET scan
干预措施: [18F] FZTA (Drug)
结局指标
主要结局
PET imaging studies of [18F]-FZTA in healthy control participants and participants with Multiple Sclerosis, and measuring the uptake of [18F]-FZTA tracer.
时间窗: Through study completion, an average of 2 years
To test the hypothesis that specific binding of \[18F\]-FZTA is elevated in participants with Multiple Sclerosis compared to healthy normal control participants.
次要结局
未报告次要终点
研究者
Tammie L. S. Benzinger, MD, PhD
Hugh Monroe Wilson Professor of Radiology
Washington University School of Medicine