Glucose Consumption in MS Using [F-18]FDG-PET
Recruiting · NCT07087106 · Interventional (participants receive a specific treatment) · Lead sponsor: Brigham and Women's Hospital
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Where it is running
1 location listed across 1 US state.
- Brigham & Women's Hospital - Boston, Massachusetts, United States