Evaluation of [18F]GATT-44 for Positron Emission Tomography Imaging of the GABA Transporter-1
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Test-Retest reproducibility calculations
研究概览
简要总结
Evaluate [18F]GATT-44 (aka [18F]GAT44), to characterize its pharmacokinetic, metabolic, and in vivo binding profile, and assess the reproducibility of kinetic and binding parameters. Assess specific binding levels of [18F]GATT-44 by conducting a test-block study in humans. Estimate human dosimetry of [18F]GATT-44 by performing whole-body imaging studies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Willing and able to give voluntary written informed consent;
- •Able to read and write, able to communicate effectively with the investigator, and comply with all study requirements, restrictions, and directions of the research staff;
- •Male or female, aged 18 to 60, at screening;
- •In good general health as evidenced by medical history, physical examination, ECG, serum/urine biochemistry, hematology, and serology tests;
- •Females of childbearing potential, and male subjects, must be willing to practice birth control for the duration of the study (unless medical documentation is provided confirming subject is permanently sterile).
排除标准
- •Less than 18 years of age;
- •Pregnant or breastfeeding;
- •Any significant systemic illness or unstable medical condition;
- •Pre-existing medical conditions or claustrophobic reactions;
- •Research-related radiation exposure exceeds current PET Center guidelines;
- •History of a bleeding disorder or are currently taking anticoagulants.
研究组 & 干预措施
Healthy Control - Whole Body
In Part 3, human dosimetry of [18F]GATT44 will be estimated by performing whole-body imaging studies
干预措施: [ 18F]GATT-44 (Drug)
Healthy Control - Test/Retest
In Part 1 we will conduct a test/retest study of the novel GABA Transporter (GAT-1) imaging tracer [18F]GATT44 in humans, to characterize its pharmacokinetic behavior and determine the reliability and reproducibility of in vivo pharmacokinetic parameter measurements
干预措施: [ 18F]GATT-44 (Drug)
Healthy Control - Test-Blocking
In Part 2, we will conduct a test-blocking study to assess specific binding levels of [18F]GATT44 in humans.
干预措施: [ 18F]GATT-44 (Drug)
结局指标
主要结局
Test-Retest reproducibility calculations
时间窗: PET Day 1 and PET Day 2
Regional TACs are analyzed with kinetic models to generate regional volume of distribution (VT), using the metabolite-corrected arterial plasma concentrations over time as input function. Standardized uptake values (SUV) may also be generated.
Specific binding levels of [18F]GATT44 in humans.
时间窗: PET Day 1 and PET Day 2
Binding potentials BPF, BPP, and BPND will be calculated from VT values, and reference models. White Matter will be the reference region to estimate nondisplaceable binding (VND).
Whole body radiation dosimetry calculated from PET-CT images
时间窗: PET Scan Day 1
Radiation absorbed doses of each organ will be calculated.
次要结局
未报告次要终点
研究者
Richard Carson
Professor of Radiology and Biomedical Imaging and of Biomedical Engineering
Yale University