Recruiting

Study of [18F]-DPA-714 PET imaging to assess neuroinflammation in multiple sclerosis patients compared to healthy controls

Fast replyInvestigational

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on Multiple Sclerosis (MS), a condition that affects the central nervous system. The research uses two imaging substances: 18F-DPA-714, a specialized radioactive tracer, and DOTAREM, a contrast agent. These substances help create detailed images of inflammation in the brain using special scanning techniques.

The main purpose is to measure ongoing inflammation in brain lesions of people with MS by using PET imaging (a specialized type of medical scan). The study will compare brain scans of MS patients to those of healthy individuals to better understand how the disease affects brain tissue. During the study, participants will receive the imaging substances through intravenous infusion (delivery directly into a vein).

The research specifically looks at areas of damage in the white matter of the brain, which is commonly affected in MS. Participants will undergo brain imaging sessions where both imaging substances will be used to create detailed pictures of inflammation patterns. This will help researchers better understand how MS affects different areas of the brain and how the disease progresses over time.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial PET scan
You will receive an intravenous injection of two substances:
First substance: 18F-DPA-714, which helps visualize inflammation in the brain
Second substance: DOTAREM (gadoteric acid), a contrast agent for better image quality
Step 2
Brain imaging procedure
The imaging procedure will be performed using a PET scanner
The scan will focus on examining your brain's white matter lesions
The procedure will create detailed images of inflammation in your brain
Step 3
Clinical assessment
Your neurological condition will be evaluated
You will complete several neuropsychological tests
These assessments will help measure your brain function
Step 4
MRI examination
An MRI scan will be performed to examine brain lesions
The scan will focus on both T1 and T2 lesions in the white matter
This imaging will provide detailed pictures of your brain structure
Step 5
Study duration
The study period runs from May 2024 to January 2026
Your participation will involve the above procedures during this timeframe

Who can join the trial?

17 criteria

Age between 18 and 55 years old
Must have Relapsing-Remitting Multiple Sclerosis (RRMS) diagnosed according to the 2017 McDonald criteria
Must have at least 9 white matter lesions above the brain stem visible on brain MRI scans
Last treatment with methylprednisolone (a steroid medication) must have been at least 1 month before PET scans
Currently not taking any disease-modifying medications for multiple sclerosis
check
Must be eligible for highly active treatment with one of these medications:
- Natalizumab
- Anti-CD20 antibody
- Alemtuzumab
- Sphingosine-1 phosphate modulator
- Cladribine
- check
  Must have either:
  - Active form of relapsing MS, or
  - Two relapses in the previous year
  - Must be enrolled in a social security scheme
  - For healthy volunteers:
    
    Age between 18 and 55 years old
    No current medical conditions
    Able to understand study procedures
    Must be enrolled in a social security scheme

Who cannot join the trial?

14 criteria

Age under 18 or over 65 years
Pregnancy or breastfeeding
Having contraindications to MRI (such as metal implants, pacemakers, or claustrophobia)
History of alcohol or substance abuse within the past year
Participation in other clinical trials within the past 30 days
Serious medical conditions that could interfere with study participation (such as heart, liver, or kidney disease)
Unable to provide informed consent
Having other neurological conditions besides multiple sclerosis
Current active infections
History of severe allergic reactions to medications or contrast agents
Immunosuppressive treatment (medications that weaken the immune system) within the past 3 months
Major surgery within the past 3 months
Abnormal blood test results that could affect safety
Unable to lie still for the duration of the PET scan (a type of medical imaging that uses small amounts of radioactive material)

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
Assistance Publique Hopitaux De Paris
Paris, France
Responsive
CHRU De Nancy
Vandoeuvre Les Nancy, France
Verified
Centre De Lutte Contre Le Cancer Eugene Marquis
Rennes, France

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Recruiting

Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

[18F]-DPA-714 is a radioactive tracer used in PET (Positron Emission Tomography) imaging. It helps doctors see inflammation in the brain and nervous system. This tracer specifically binds to cells that are involved in inflammation, making them visible during the scan. It's not a treatment but rather a diagnostic tool that helps doctors understand the level of inflammation in the brain, particularly in people with multiple sclerosis.

N,N-Diethyl-2-(2-(4-(2[(18)F]-Fluoroethoxy)Phenyl)5,7Dimethylpyrazolo[1,5A]Pyrimidin-3-Yl)Acetamide

What is already known about the treatment

[18F]-DPA-714 – A radioactive tracer used in Positron Emission Tomography (PET) imaging, administered through intravenous injection for diagnostic purposes. This specialized imaging agent is designed to bind to specific proteins associated with neuroinflammation, particularly in multiple sclerosis patients. It works by targeting and highlighting areas of active inflammation in the brain's white matter, allowing doctors to visualize and measure the extent of ongoing inflammatory processes in multiple sclerosis lesions. This tracer belongs to the class of radiopharmaceuticals used in molecular imaging and is currently being studied in clinical trials to better understand and monitor the progression of multiple sclerosis.

Investigated diseases

Multiple Sclerosis - A chronic disease affecting the central nervous system, where the immune system mistakenly attacks the protective covering of nerve fibers called myelin. The damage to myelin leads to communication problems between the brain and the rest of the body, causing various symptoms that can come and go. The disease typically causes patches of inflammation called lesions that can occur in different areas of the brain and spinal cord. These lesions can develop into scarred tissue, which is why the condition is called sclerosis. The disease can progress differently in each person, with some experiencing periods of new symptoms followed by quiet periods without symptoms, while others may see a gradual onset of symptoms over time.