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Glucose Consumption in MS Using [F-18]FDG-PET

StatusRecruiting
PhasePhase 4
Started2025-05-31
View on ClinicalTrials.gov ↗

Amendment history

2026-01-07
Not Yet Recruiting→Recruiting Study Status, Study Description, Study Design, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Primary completion date2025-12-31→2027-12-31
Completion date2026-05-31→2027-12-31
Start dateestimated 2025-07→confirmed 2025-05-31
Eligibility criteria+4 characters
Inclusion Criteria: Age 18 to 70 years. Subjects meeting the definition for MS (including SPMS, RRM [...] e recruited. Subjects willing to undergo PET and MRI imaging. Subjects willing and able to give informed consent. Exclusion Criteria: Individuals with a known alternate neur [...] rent medical conditions that contraindicate study procedures. Women who are pregnant or nursing. Also, any woman who is s [...] ollment. Claustrophobia Non-MRI compatible implanted devices. Corticosteroid treatment in the past four weeks.
Secondary endpoints7 to 1 entries
SUVCorrelations Ratiobetween (SUVR) BrainPET Parenchymalmeasurements Volumeand (BPV) clinical, MRI, lesionand volume Expandedblood Disabilityand Statusserum Scale (EDSS) Timed 25-Foot Walk (T25FW) Modified Fatigue Impact Scale (MFIS) Brief Repeatable Battery of Neuropsychological Tests in MS (BRB)measures
Primary endpoints1 entry, revised
StandardizedPET Uptakemeasurements Valuein (SUV)individuals with PMS, RRMS, and healthy controls
Study description-22 characters
[...] ects will be recruited: Subjects meeting the definition for progressive MSPMS, (secondary progressive MS (SPMS) or primary progressive MS [...] investigators plan to enroll 50 subjects including 20 with progressive MSPMS (SPMS or PPMS), 20 with RRMS and 10 healthy controls. In or [...]
Study sitesdetails revised at 1 of 1 site
2025-07-17
Original filing
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.
Trial Details
NCT Number NCT07087106
Lead Sponsor Brigham and Women's Hospital
Collaborators: Genzyme, a Sanofi Company
Conditions Multiple Sclerosis
Enrollment 50 participants
Start Date 2025-05-31
Primary Completion 2027-12-31 (estimated)
Study Completion 2027-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-01-09