AuthorisedTherapeutic exploratory (Phase II)Interventional

Role of Neuroinflammation and Blood-Brain Barrier Breakdown in Intracerebral Hemorrhage. The INFINITE Study

The INFINITE study is a Phase II clinical trial investigating brain bleeds, also known as intracerebral hemorrhage. Researchers are trying to understand how inflammation and damage to the brain's tiny blood vessels (the blood-brain barrier) affect how well people recover after this type of stroke. They will use a special scanning technique involving a tracer called 18F-DPA-714 to measure changes in the brain. They will then compare these measurements to a person's physical and mental recovery six months after the brain bleed, using a scale that measures daily function from no symptoms to death. The study aims to see if specific brain changes measured by the scans can help predict a patient's long-term recovery.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Centre Hospitalier Universitaire De Toulouse

Enrolment target

117

Start

10 Oct 2025

Intracerebral hemorrhage.

What is this study about?

When someone has a brain bleed, also known as an intracerebral hemorrhage, it's a serious type of stroke where blood leaks into the brain. This can damage brain cells and affect how well a person can move, think, and speak. Doctors are always looking for better ways to understand what happens in the brain after such an event and how that affects a person's recovery.

This study, called INFINITE, is a Phase II trial. This means it's an early-stage study to learn more about a new way of looking at certain processes, rather than testing a new treatment. Researchers believe that two things might play a big role in how someone recovers: inflammation (the body's natural response to injury) and damage to the blood-brain barrier. The blood-brain barrier is like a protective shield that controls what gets in and out of the brain's blood vessels. When it's damaged, harmful substances might enter the brain and cause more injury.

To see these changes, the study uses a special tracing substance called 18F-DPA-714, combined with a type of scan called a PET scan. This tracer helps light up areas of inflammation in the brain. By comparing what these scans show with how well people are doing six months later, the researchers hope to better understand the link between these brain changes and recovery. This knowledge could eventually help doctors predict a person's recovery more accurately and potentially lead to new treatments in the future.

Key takeaways

The INFINITE study explores brain inflammation after a brain bleed.
It uses special scans to understand how brain changes link to recovery.
The study aims to improve understanding of intracerebral hemorrhage.
Participation involves scans, blood tests, and health assessments over six months.
It's an early-stage study to gather information, not to test a new treatment.

Who may be eligible?

This study is open to both men and women aged 18 years and older. There is no upper age limit set for participants.

To be considered for the study, you would need to have had an intracerebral hemorrhage (a type of brain bleed). The study team will check other medical details to see if you meet all the specific requirements for participation, such as how recently your brain bleed occurred and other health conditions.

It's important to discuss your full medical history with the study team to determine if this study is right for you. They will explain all the criteria in detail.

Quick self-check

Are you 18 years old or older?
Have you recently had a brain bleed (intracerebral hemorrhage)?
Are you willing and able to attend study visits for six months?
Are you comfortable with having brain scans (PET and MRI) and blood tests?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

Taking part in this study would involve several assessments over a period of about six months. You would have special brain scans using a tracer called 18F-DPA-714. These are non-invasive scans that help doctors see what's happening inside your brain's cells. You would also have regular check-ups to assess your overall health and how well you are recovering from the brain bleed. This includes tests to measure your physical abilities and your ability to carry out daily tasks. Blood samples would also be taken at specific times to look for markers of inflammation. They would also do MRI scans to get detailed pictures of your brain. The total duration of your active participation, including follow-up, would be around six months.

Potential risks and benefits

Taking part in a clinical study can offer several potential benefits, such as closely monitored care for your condition and contributing to medical knowledge that may help others in the future. In this study, you would receive advanced brain imaging that could provide detailed information about your condition. Potential risks might include those associated with the special scans, such as exposure to a small amount of radiation from the PET scan (similar to other medical scans) or potential reactions to the contrast dye used in the MRI. Drawing blood samples can cause slight discomfort or bruising. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

—
France

Common questions

What is an intracerebral hemorrhage?

It's a type of stroke where bleeding occurs directly inside the brain tissue, which can cause damage and affect brain function.

What is 18F-DPA-714?

It's a special substance, called a tracer, that is used with PET scans to help doctors see and measure inflammation in the brain.

What is a 'Phase II' study?

It's an early stage of clinical research. Instead of testing a new drug, this study explores how certain processes (like inflammation) affect recovery after a brain bleed.

How will my recovery be measured?

Your recovery will be measured using a scale called the modified Rankin scale, which assesses how well you can perform daily activities and looks at your overall independence.

Will I receive treatment in this study?

This study is focused on understanding the disease processes and predicting outcomes, rather than providing or testing a new treatment for the brain bleed itself.