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

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What is this study about?

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.

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

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

3 Clinical assessment

Your neurological condition will be evaluated

You will complete several neuropsychological tests

These assessments will help measure your brain function

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

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 Study?

  • 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
  • Must be eligible for highly active treatment with one of these medications:
    • Natalizumab
    • Anti-CD20 antibody
    • Alemtuzumab
    • Sphingosine-1 phosphate modulator
    • Cladribine
  • 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 Study?

  • 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)

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Oncopole Claudius Regaud Toulouse France

Other Sites

Site Name City Country Status
Centre Hospitalier Universitaire De Rennes Rennes France
Centre Hospitalier Lyon Sud Pierre Benite France
Hopital Beaujon Clichy France
Centre De Lutte Contre Le Cancer Eugene Marquis Rennes France
Commissariat a l’Energie Atomique et aux Energies Alternatives Orsay France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Recruiting
01.09.2025

Trial locations

[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.

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.

Trial ID:
2023-510304-53-00
NCT ID:
NCT06280742
Trial Phase:
Therapeutic use (Phase IV)

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