A Study to Characterize the Novel TSPO PET Radioligand [18F]PBR111 as an in Vivo Marker of Microglial Activation in Multiple Sclerosis
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- VT of [18F]PBR111
研究概览
简要总结
This is a study aimed to characterize [18F]PBR111 as an in vivo marker of microglial activation in Multiple Sclerosis. Regional binding of [18F]PBR111 will be quantified with PET in the brain of up to 24 patients with multiple sclerosis and up to 24 age- and gender- matched healthy volunteers.
详细描述
Multiple Sclerosis is characterized by brain areas of focal neuroinflammation. Imaging of microglia activation in multiple sclerosis could represent a useful marker of neuroinflammation. A novel PET tracer with high affinity to TSPO, [18F]PBR111, is a promising tool for PET imaging of activated microglia.
This is a study aimed to characterize [18F]PBR111 as an in vivo marker of microglial activation in Multiple Sclerosis. Regional binding of [18F]PBR111 will be quantified with PET in the brain of up to 24 patients with multiple sclerosis and up to 24 age- and gender- matched healthy volunteers. A subgroup of patients and healthy volunteers will be scanned twice in consecutive days, to test the reproducibility of the measure. Another subgroup of patients will be re-scanned with [18F]PBR111 after 4-6 months. MRI-based measures will be acquired at baseline and, in those patients with later repeat PET scans, also after 4-6 months.
Data from this study will inform about the possible implementation of the [18F]PBR111 ligand to monitor the neuroinflammatory process, disease progression, and response to treatment in MS patients.
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
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or Female, aged 20-70
- •Able to read, comprehend and record information written in English.
- •Capable of giving written informed consent
- •Provide a venous blood sample that will be used for genetics research and the in vitro ligand binding assay.
- •A female subject is eligible to participate if she is willing to follow contraception guidelines or if she is of non-childbearing potential.
- •Male subjects must agree to use one of the contraception methods
- •MS subjects:
- •Clinical or clinical and laboratory supported diagnosis of multiple sclerosis
- •EDSS score up to and including 7.5 at screening evaluation
- •Healthy Volunteers:
- •Healthy control subjects defined as free from clinically significant active disease as assessed by the Principal Investigator from their medical and psychiatric past and present history
排除标准
- •If female, positive urine pregnancy test
- •An estimated glomerular filtration rate (eGFR) of less than 60 ml/kg/1.73m2
- •History or presence of a neurological diagnosis
- •Previous inclusion in a research and/or medical protocol involving nuclear medicine, PET or radiological investigations with radiation exposure.
- •Family history of cancer (one or more first-degree relative diagnosed before the age of 55).
- •Subject or caregiver is an immediate family member or employee of the participating Investigator, any of the participating site staff or GSK staff.
- •Any subject the investigator deems unsuitable for the study (e.g., due to either medical reasons, laboratory abnormalities or subject's unwillingness to comply with all study-related procedures).
- •Contraindications to MRI scanning
- •Any physical abnormality or functional disability which prevents the subject from acquiring a suitable position for scanning.
- •History of or suffers from claustrophobia or feels that he will be unable to lie still on his back in the PET camera or MRI scanner for a period of at least 90mins.
- •Unwillingness or inability to follow the procedures outlined in the protocol. -
结局指标
主要结局
VT of [18F]PBR111
时间窗: day 30
Regional VT of \[18F\]PBR111 at baseline in MS patients and age- , gender-, and TSPO binding profile- matched healthy controls
次要结局
- White matter lesion load and distribution(1.5 years)
- Test-retest variability of regional [18F]PBR111(8 months)
- regional [18F]PBR111 VT(1.5 years)
- Cortical grey matter lesion load and distribution(1.5 years)
- Genetic polymorphisms related to the TSPO gene(1.5 years)