Assessment of [18F]SF12051 for Imaging the 18-kDa Translocator Protein (TSPO) in Brain and Whole Body of Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Whole Body PET Uptake of [18F]SF12051 - Phase 1
研究概览
简要总结
Background:
Inflammation in the brain plays a role in many diseases. Being able to measure inflammation in a person's brain might help to diagnose and treat these diseases. One protein (TSPO) appears in higher numbers when inflammation affects the brain. To see TSPO when a person's body is scanned, researchers need a substance called a radiotracer that will attach to this protein and no other molecules.
Objective:
This study will test whether a new radiotracer ([18F]SF12051) can make TSPO appear on PET scans of a person's brain and body.
Eligibility:
Healthy people aged 18 and older.
Design:
This study requires 2 to 4 visits to the clinic.
All participants will be screened. They will have a physical exam. They will have blood tests and a test of their heart function.
Some participants will have a positron emission tomography (PET) scan of the whole body. The radiotracer will be injected through a tube (catheter) placed in a vein in the arm. The PET scanner is a machine shaped like a doughnut. Participants will lie on a bed that slides in and out of the scanner. The scan will take about 2 hours.
Some participants will have a PET scan of just their head. After they are injected with the radiotracer, they will lie on a bed with their head in the scanner. Blood will be drawn from a catheter in the wrist during the scan.
Some participants will have a magnetic resonance imaging (MRI) scan of the brain. They will lie on a narrow bed that slides into a tube.
详细描述
Study Description:
This study is intended to provide information on the novel [18F]SF12051 radioligand and its ability to localize and measure TSPO in the brain and body of healthy individuals.
Objectives:
Primary Objective: To study the brain uptake of [18F]SF12051 and perform kinetic modeling of the [18F]SF12051 in the three different TSPO genotypes.
Secondary Objectives: To study the brain retest characteristics, biodistribution and dosimetry of [18F]SF12051 in healthy subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
High affinity binder (HAB) Translocator Protein (TSPO) genotype
Healthy participants with HAB TSPO genotype receive 18F-SF12051 intravenously followed by whole body or brain positron emission tomography (PET) scan. Participants were randomized to either phase 1, 2, or 3. Phases 1 & 3 had whole body PET scan and phase 2 had brain PET scan.
干预措施: 18F-SF12051 (Drug)
Low affinity binder (LAB) Translocator Protein (TSPO) genotype
Healthy participants with LAB TSPO genotype receive 18F-SF12051 intravenously followed by whole body or brain positron emission tomography (PET) scan. Participants were randomized to either phase 1, 2, or 3. Phases 1 & 3 had whole body PET scan and phase 2 had brain PET scan.
干预措施: 18F-SF12051 (Drug)
Mixed affinity binder (MAB) Translocator Protein (TSPO) genotype
Healthy participants with MAB TSPO genotype receive 18F-SF12051 intravenously followed by whole body or brain positron emission tomography (PET) scan. Participants were randomized to either phase 1, 2, or 3. Phases 1 & 3 had whole body PET scan and phase 2 had brain PET scan.
干预措施: 18F-SF12051 (Drug)
结局指标
主要结局
Whole Body PET Uptake of [18F]SF12051 - Phase 1
时间窗: Up to 120 minutes during the scan
Participant received whole body PET scan and Uptake of \[18F\]SF12051 was measured using the Siemens Biograph mCT. Organ dosimetry was measured as microsieverts per mega-becquerel (uSv/MBq).
Brain PET Uptake of [18F]SF12051 - Phase 2
时间窗: Up to 120 minutes during the scan
Participant received brain PET scan and Uptake of \[18F\]SF12051 was measured using the Siemens Biograph mCT. Volume of distribution (Vt) was calculated via 2-Tissue-Compartment Model with plasma input function.
Whole Body PET Uptake of [18F]SF12051 - Phase 3
时间窗: Up to 120 minutes during the scan
Participant received whole body PET scan and Uptake of \[18F\]SF12051 was measured using the Siemens Biograph mCT. Organ dosimetry was measured as microsieverts per mega-becquerel (uSv/MBq).
次要结局
- Test-Retest Variability of [18F]SF12051(Up to 120 minutes during the scan)
- Test-Retest Reliability of [18F]SF12051(Up to 120 minutes during the scan)
- Area Under the Organ Time-Activity Curves From 0-120 - Phase 1(Up to 120 minutes during the scan)
- Area Under the Organ Time-Activity Curves From 0-120 - Phase 3(Up to 120 minutes during the scan)