Recruiting

FDG-PET

Sponsor:

Brigham and Women's Hospital

Code:

NCT07087106

Conditions

Multiple Sclerosis

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Accepted

Interventions

[F-18]FDG

Study Details

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

Study ID

NCT07087106

Start date

May 31, 2025

Status verified date

Jan, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Accepted

Inclusion Criteria:

1. Age 18 to 70 years.
2. 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.
3. Subjects willing to undergo PET and MRI imaging.
4. Subjects willing and able to give informed consent.

Exclusion Criteria:

1. Individuals with a known alternate neurologic disorder, previous head injury, or substance abuse.
2. Individuals with a known alternate neuropsychiatric disorder, including bipolar disease and schizophrenia.
3. Concurrent medical conditions that contraindicate study procedures
4. 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.
5. Claustrophobia
6. Non-MRI compatible implanted devices.
7. Corticosteroid treatment in the past four weeks.

Study Design

Enrollment

50 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: PMS, RRMS, and Healthy Control subjects

Interventions

[F-18]FDG

PET radiopharmaceutical

Primary outcome measure

  • PET measurements in individuals with PMS, RRMS, and healthy controls [ Time Frame: Baseline ]

Central Contacts and Locations

Central contacts

Nicolas Horan

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

Steven Cicero

scicero@bwh.harvard.edu

Locations

Brigham & Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Nicolas Horan

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

More Information

Sponsor

Brigham and Women's Hospital

Last update posted

Jan 9, 2026

Last verified

Jan, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Brigham and Women's Hospital on 2026-01-09.