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

NCT07087106 | Recruiting Phase 4 FDA Drug

• 1 other identifier: 2025P000883
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Multiple Sclerosis

Keywords

Multiple Sclerosis; MS; FDG; Positron Emission Tomography; PET

Outcome Measures

Primary Outcomes (1)

• PET measurements in individuals with PMS, RRMS, and healthy controls

  To compare PET measurements including standardized uptake value (SUV) and standardized uptake value ratio (SUVR) in individuals with PMS, RRMS, and healthy controls.

  Baseline

Secondary Outcomes (1)

• Correlations between PET measurements and clinical, MRI, and blood and serum measures

  Baseline

Study Arms (1)

PMS, RRMS, and Healthy Control subjects

EXPERIMENTAL

Drug: [F-18]FDG

Interventions

[F-18]FDG DRUG

PET radiopharmaceutical

PMS, RRMS, and Healthy Control subjects

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Genzyme, a Sanofi Company: collaborator
• Brigham and Women's Hospital: lead

Study Sites (1)

Brigham & Women's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Tarun Singhal, MD, MBBS

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nicolas Horan

CONTACT

617-264-3044; nhoran@bwh.harvard.edu

Steven Cicero

CONTACT

scicero@bwh.harvard.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Neurology

Study Record Dates

• First Submitted: June 13, 2025
• First Posted: July 25, 2025
• Study Start: May 31, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: January 9, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)