Novel Assessment of Glucose Consumption in Multiple Sclerosis Utilizing [F-18]FDG-PET
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- PET measurements in individuals with PMS, RRMS, and healthy controls
研究概览
简要总结
Given the need for better diagnostic imaging techniques in multiple sclerosis (MS), the study aims to investigate the utility of [F-18]FDG positron emission tomography (PET) in MS. The study will be assessing glucose consumption patterns in subjects with progressive MS (PMS) and relapsing-remitting MS (RRMS), as well as healthy controls. PET will be compared to magnetic resonance imaging (MRI) lesion load and brain atrophy, and serum and blood biomarkers, as well as clinical measures of physical disability, cognitive impairment, fatigue, and depression. This study's findings may pave a path for integrating [F-18]FDG-PET in routine clinical practice for MS, improving patient experiences and outcomes.
The specific aims of the study are:
Aim 1: To compare glucose consumption in the brain in subjects with PMS, relapsing-remitting MS (RRMS), and healthy controls, using the radiolabeled glucose analogue 18-fluorodeoxyglucose, also known as [F-18]FDG.
Aim 2: To compare the relationship between FDG-PET and standard 3T MRI measures including global and regional brain atrophy and lesion load, and to compare FDG-PET with MRI in terms of their relationship with clinical measures of physical disability, cognitive impairment, fatigue and depression in MS subjects.
Aim 3: To assess the relationship of FDG-PET with serum and blood biomarkers, including but not limited to sNfL, GFAP, IL-6, and TNFα in MS.
详细描述
This is a single center, cross-sectional study of the measurement of glucose consumption using [F-18]FDG-PET in subjects with progressive MS as compared to RRMS and healthy controls.
Three groups of subjects will be recruited:
- Subjects meeting the definition for PMS, (secondary progressive MS (SPMS) or primary progressive MS (PPMS), by International Panel Criteria
- Subjects meeting the definition for RRMS by the International Panel Criteria,
- Healthy Controls
Sample Size: The investigators plan to enroll 50 subjects including 20 with PMS (SPMS or PPMS), 20 with RRMS and 10 healthy controls.
In order to attain the goal sample size of 50 subjects, the investigators estimate that they may need to consent approximately 60 subjects to account for screen failures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18 to 70 years.
- •Subjects meeting the definition for MS (including SPMS, RRMS or PPMS) by International Panel (2017 McDonald) Criteria. Age and sex-matched healthy controls will also be recruited.
- •Subjects willing to undergo PET and MRI imaging.
- •Subjects willing and able to give informed consent.
排除标准
- •Individuals with a known alternate neurologic disorder, previous head injury, or substance abuse.
- •Individuals with a known alternate neuropsychiatric disorder, including bipolar disease and schizophrenia.
- •Concurrent medical conditions that contraindicate study procedures
- •Women who are pregnant or nursing. Also, any woman who is seeking to become pregnant or suspects she is pregnant will be excluded from enrollment.
- •Claustrophobia
- •Non-MRI compatible implanted devices.
- •Corticosteroid treatment in the past four weeks.
研究组 & 干预措施
PMS, RRMS, and Healthy Control subjects
干预措施: [F-18]FDG (Drug)
结局指标
主要结局
PET measurements in individuals with PMS, RRMS, and healthy controls
时间窗: Baseline
To compare PET measurements including standardized uptake value (SUV) and standardized uptake value ratio (SUVR) in individuals with PMS, RRMS, and healthy controls.
次要结局
- Correlations between PET measurements and clinical, MRI, and blood and serum measures(Baseline)
研究者
TARUN SINGHAL
Associate Professor of Neurology
Brigham and Women's Hospital