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Novel Assessment of Glucose Consumption in Multiple Sclerosis Utilizing [F-18]FDG-PET

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: t
View:

• 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.

Locations
United States
Massachusetts
Brigham & Women's Hospital
RECRUITING
Boston
Contact Information
Primary
Nicolas Horan
nhoran@bwh.harvard.edu
617-264-3044
Backup
Steven Cicero
scicero@bwh.harvard.edu
Time Frame
Start Date: 2025-05-31
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 50
Treatments
Experimental: PMS, RRMS, and Healthy Control subjects
Related Therapeutic Areas
Sponsors
Leads: Brigham and Women's Hospital
Collaborators: Genzyme, a Sanofi Company

This content was sourced from clinicaltrials.gov

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