Multiple Sclerosis study: F-18
Official title Investigating the Utility of Demyelination Tracer [18F]3F4AP in Controls and Multiple Sclerosis Subjects
ClinicalTrials.gov ID: NCT04699747
What this study is testing
What is F-18 3F4AP?
This is an investigational radioactive tracer being studied to help doctors see images of the brain in people with multiple sclerosis.
Also referred to as [18F]3F4AP.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study will check if the tracer is safe, how it moves in the brain, and whether it can show differences between healthy tissue and damaged areas in MS. It will also see if the scan results match MRI findings and MS symptoms.
- Who it's for
- Adults who have multiple sclerosis or are healthy volunteers without MS.
- What's involved
- Participants will receive a small injection of the tracer and then undergo a PET brain scan. They may also have MRI scans and cognitive tests. The study will repeat scans to check consistency.
- Time commitment
- The study lasts about a week, with a PET scan day and a follow‑up scan a few days later, plus any required MRI or test appointments.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65. Healthy volunteers may be eligible.
You may be able to join if
- people must be ≥18 and \<65 years of age;
- Able to understand and provide informed consent prior to study procedures
You likely can't join if
- people with known structural brain disease (e.g. brain tumor or stroke);
- people with life vest;
- people with implanted heart device (e.g. ICD, Pacemaker);
- people with metallic fragment or foreign body;
- people with other form of devices or prosthesis that are not MRI compatible, such as insulin pump, joint replacement, hearing aid, cochlear implant...
- people with severe claustrophobia
See the full eligibility criteria
- people must be ≥18 and \<65 years of age;
- Able to understand and provide informed consent prior to study procedures
- people with known structural brain disease (e.g. brain tumor or stroke);
- people with life vest;
- people with implanted heart device (e.g. ICD, Pacemaker);
- people with metallic fragment or foreign body;
- people with other form of devices or prosthesis that are not MRI compatible, such as insulin pump, joint replacement, hearing aid, cochlear implant, permanent contraceptive devices, etc.;
- people with severe claustrophobia
- history of renal disease including acute or chronic severe renal insufficiency (glomerular filtration rate \<60 mL/min/1.73m2);
- history of diabetes mellitus, systemic lupus, multiple myeloma, nephrogenic systemic fibrosis, and other co-morbidities;
- History of hypersensitive reactions to Dotarem and/or gadolinium contrast agent;
- Radiation exposure exceeds current Radiology Department guidelines (i.e., 50 mSv in the prior 12 months);
- Female people only: Positive serum pregnancy test, or lactating, or possibility of pregnancy cannot be ruled out prior to dosing;
- Inability to provide written informed consent;
- Any clinically significant acute or unstable physical or psychiatric condition, judged by the investigators based on medical history or screening physical examination, to be incompatible with the study;
- Any physical or psychiatric condition judged by the investigators to be incompatible with the study, based on medical history or screening physical examination;
- Abnormal results on blood tests judged by the investigators to be incompatible with the study.
The study team makes the final eligibility decision.
Where it is enrolling
- Boston, Massachusetts, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Boston, Massachusetts, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.