[F-18]FDG-PET for MS

Overseen By Steven Cicero

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Brigham and Women's Hospital

Must not be taking: Corticosteroids

Disqualifiers: Neurologic disorder, Substance abuse, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 5

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new imaging technique called [F-18]FDG-PET to determine its effectiveness in diagnosing and monitoring multiple sclerosis (MS). The goal is to assess whether this method can better track glucose use in the brains of people with MS compared to the usual MRI scans. The trial also examines how this imaging correlates with symptoms such as physical disability, cognitive issues, fatigue, and depression. Individuals with progressive MS, relapsing-remitting MS, or healthy individuals without MS who can undergo PET and MRI scans may be suitable candidates for the trial. As a Phase 4 trial, this research aims to understand how this already FDA-approved technique can benefit more patients.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you've had corticosteroid treatment in the past four weeks.

What is the safety track record for [F-18]FDG?

Research has shown that [F-18]FDG, a special type of glucose used in PET scans, is generally safe for people. It helps doctors study how the brain uses sugar, aiding in understanding conditions like multiple sclerosis (MS).

The procedure involves some radiation exposure, about 18% of the annual limit for radiation workers. This exposure level is considered low.

Overall, [F-18]FDG is widely used in medical imaging and has a strong safety record. It is well-established in the medical field, and evidence suggests it is safe for human use. ^{1 2 3 4 5}

Why are researchers enthusiastic about this trial?

Researchers are excited about using [F-18]FDG-PET for multiple sclerosis (MS) because it offers a new way to visualize disease activity in the brain. Unlike traditional treatments for MS, such as disease-modifying therapies that primarily aim to slow progression and reduce relapses, [F-18]FDG-PET is a diagnostic technique that can help identify active inflammation and metabolic changes in the brain. This imaging method uses a special form of glucose that highlights areas of high activity, potentially allowing for a more precise assessment of how the disease is affecting the brain. This could lead to more personalized treatment plans and better monitoring of how patients are responding to therapies.

What evidence suggests that [F-18]FDG-PET is effective for diagnosing MS?

Research shows that [F-18]FDG-PET can enhance understanding of brain activity in people with multiple sclerosis (MS). Studies have found that [F-18]FDG-PET effectively detects changes in brain glucose (energy) usage, which can relate to MS symptoms. This method might clarify the cognitive and mental challenges often observed in MS. In this trial, [F-18]FDG-PET will reveal differences in energy use between people with and without MS. Although researchers continue to study this technique, it could improve how doctors understand and treat MS. ^{1 2 3 6 7}

Who Is on the Research Team?

Tarun Singhal, MD, MBBS

Principal Investigator

Brigham and Women's Hospital

Are You a Good Fit for This Trial?

This trial is for individuals aged 18 to 70 with Multiple Sclerosis (MS), including those with progressive, relapsing-remitting, or primary progressive forms. Participants must be willing to undergo PET and MRI imaging and able to give informed consent. Healthy controls matching the age and sex of MS patients are also eligible.

Inclusion Criteria

I am willing and able to give informed consent.

I have been diagnosed with multiple sclerosis as per the 2017 McDonald criteria.

I am between 18 and 70 years old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Initial Visit

Subjects will be administered the screening questionnaire, review and sign the consent form, and undergo cognitive testing and blood sample collection.

1 day

1 visit (in-person)

PET Visit

Subjects undergo a PET scan with radiopharmaceutical injection and pregnancy testing for women of childbearing age.

1 day

1 visit (in-person)

MRI Visit

Subjects undergo a 3T Brain MRI scan, with pregnancy screening for women.

1 day

1 visit (in-person)

Follow-up

Follow-up phone call to ensure no side effects post-PET scan.

1-3 days

1 call (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• [F-18]FDG

Trial Overview

[F-18]FDG-PET scans are being tested against standard MRI measures in people with different types of MS and healthy controls. The study aims to see how well [F-18]FDG-PET shows glucose consumption in the brain compared to MRI's ability to show lesion load and brain atrophy.

How Is the Trial Designed?

Group I: PMS, RRMS, and Healthy Control subjects Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Brigham and Women's Hospital

Lead Sponsor

Trials

1,694

Recruited

14,790,000+

Genzyme, a Sanofi Company

Industry Sponsor

Trials

528

Recruited

186,000+

David Meeker

Genzyme, a Sanofi Company

Chief Executive Officer since 2011

MD from the University of Vermont Medical School, Advanced Management Program at Harvard Business School

Jean-Paul Kress

Genzyme, a Sanofi Company

Chief Medical Officer since 2015

MD from Faculte Necker-Enfants Malades, Paris

Citations

1.

nature.com

nature.com/articles/sc2014130

Glucose uptake of the spinal cord in patients with multiple ...

The purpose of this study was to determine whether uptake of [ 18 F]-FDG is also lower in the spinal cord of mildly disabled patients with MS.

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC5023680/

Precision Medicine in Multiple Sclerosis: Future of PET ...

[18F]FDG has some valuable characteristics for monitoring cognitive and mental dysfunctions associated with MS (Paulesu et al., 1996; Zarei, 2003; Buck et al., ...

3.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07087106

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

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 ...

4.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/39692831/

Dynamic 18 F-FDG PET to detect differences among ...

Dynamic 18 F-FDG PET-MRI is a feasible technique that may show information in vivo of glucose metabolism in MS.

5.

jneuroinflammation.biomedcentral.com

jneuroinflammation.biomedcentral.com/articles/10.1186/s12974-018-1080-1

[ 18 F]FSPG-PET reveals increased cystine/glutamate ...

These data highlight the promise of [18F]FSPG-PET as a technique to provide insights into neuroimmune interactions in MS and the in vivo role of ...

6.

research.rug.nl

research.rug.nl/files/6634695/02_c2.pdf

In vivo evaluation of [18F]-FEAnGA: a PET tracer for Imaging

In multiple sclerosis, [18F]FDG PET has been used as marker for inflammation and for neurodegeneration. Thirteen MS patients (RRMS, SPMS and PPMS) in a ...

7.

ashpublications.org

ashpublications.org/blood/article/114/10/2068/25766/F18-fluorodeoxyglucose-positron-emission

F18-fluorodeoxyglucose positron emission tomography in the ...

Survival was adversely affected by MRI-FL independent of the presence of cytogenetic abnormalities (CAs).7. F18-fluorodeoxyglucose positron emission tomography ...