NCT07087106 Glucose Consumption in MS Using [F-18]FDG-PET
| NCT ID | NCT07087106 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Brigham and Women's Hospital |
| Condition | Multiple Sclerosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2025-05-31 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 50 participants in total. It began in 2025-05-31 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Tarun Singhal, MD, MBBS
PRINCIPAL INVESTIGATOR
Brigham and Women's Hospital
Frequently Asked Questions
Who can join the NCT07087106 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Multiple Sclerosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07087106 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07087106 currently recruiting?
Yes, NCT07087106 is actively recruiting participants. Contact the research team at nhoran@bwh.harvard.edu for enrollment information.
Where is the NCT07087106 trial being conducted?
This trial is being conducted at Boston, United States.
Who is sponsoring the NCT07087106 clinical trial?
NCT07087106 is sponsored by Brigham and Women's Hospital. The principal investigator is Tarun Singhal, MD, MBBS at Brigham and Women's Hospital. The trial plans to enroll 50 participants.
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