[F-18]FDG-PET for MS
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.12345Why 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.12367
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
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Initial Visit
Subjects will be administered the screening questionnaire, review and sign the consent form, and undergo cognitive testing and blood sample collection.
PET Visit
Subjects undergo a PET scan with radiopharmaceutical injection and pregnancy testing for women of childbearing age.
MRI Visit
Subjects undergo a 3T Brain MRI scan, with pregnancy screening for women.
Follow-up
Follow-up phone call to ensure no side effects post-PET scan.
What Are the Treatments Tested in This Trial?
Interventions
- [F-18]FDG
Find a Clinic Near You
Who Is Running the Clinical Trial?
Brigham and Women's Hospital
Lead Sponsor
Genzyme, a Sanofi Company
Industry Sponsor
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