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Study of [18F]MC225 PET to Assess Blood‑Brain Barrier Function in Patients with Suspected Glioblastoma

Verified siteInvestigationalNo placebo

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What is this trial about?

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

The study looks at people who have a brain tumor called Glioblastoma. A special imaging substance called [¹⁸F]MC225 will be given by an intravenous injection. This substance allows a type of scan called PET to see how a protective layer called the blood–brain barrier works. The blood–brain barrier controls which chemicals can enter the brain, and a protein called P-glycoprotein helps pump unwanted substances out.

The purpose is to measure how well this protein functions in different parts of the tumor and surrounding brain tissue. After the injection, participants will have a PET scan that captures images of the tracer moving through the brain, and they may also have an MRI scan that uses a contrast dye to show the tumor shape and blood flow. The scans are compared to normal brain areas, and the information helps researchers understand the barrier’s activity in people with suspected Glioblastoma. The study involves a few visits over a short period, each including the injection and imaging procedures.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Schedule and prepare for brain pet scan
After enrollment, a date is arranged for the brain pet scan. you will be asked to avoid eating or drinking for a short period before the appointment, unless instructed otherwise.
Step 2
Check‑in and confirm eligibility
On the day of the scan, you check in at the imaging center. staff verify that you have no recent illnesses, allergies, or other conditions that would prevent the injection of the tracer.
Step 3
Receive intravenous injection of <b>[¹⁸f]mc225</b>
A nurse inserts a small needle into a vein in your arm. a solution for injection containing [¹⁸f]mc225 is given directly into the bloodstream.
The amount of tracer is 400 mbq (megabecquerel), which is a unit that describes the radioactivity of the substance. this is a single dose given only once for the study.
Step 4
Undergo brain pet imaging
Immediately after the injection, you lie on a table that moves into the pet scanner. the scanner records how the tracer moves into and out of different parts of the brain.
The imaging session typically lasts about one hour, during which you are asked to stay still and may be given simple instructions to keep breathing normally.
Step 5
Post‑scan observation
When the scan is finished, you remain in a quiet area for a short period while staff monitor you for any immediate reactions to the tracer. most people experience no side effects.
Step 6
Study completion and follow‑up
After observation, the imaging data are analyzed to measure the function of the blood‑brain barrier in the tumor area. you may be asked to complete a brief questionnaire about how you felt during the visit, but no additional medication is given.

Who can join the trial?

8 criteria

Be at least 18 years old.
Have a brain scan that shows a possible glioblastoma (a type of aggressive brain tumor).
Be planned to have surgery that removes part of the tumor (tumor reductive surgery).
The tumor should be mainly on one side of the brain (unilateral) so that detailed imaging can be done.
Be able to safely receive a special type of scan called contrast‑enhanced MRI, which uses a dye to improve picture quality.
Be able to have a PET imaging scan and have blood taken from an artery and a vein (arterial and venous blood sampling) as part of the study.
Be able to understand the study information and sign a written informed consent form.
Agree that all imaging tests can be done within 14 days before surgery without delaying your regular medical care (standard clinical care).

Who cannot join the trial?

6 criteria

You cannot join the study if any condition makes the procedures unsafe, such as having metal implants that are not safe for MRI, a serious allergy to the gadolinium‑based contrast dye, or kidney problems that affect how the dye is cleared.
Being pregnant or breastfeeding prevents participation.
If you are unable to understand the study and give informed consent, you cannot take part.
Having certain neurological (brain‑related) or psychiatric (mental health) conditions that could affect the scans or their interpretation makes you ineligible.
Taking medicines that strongly change the activity of P‑glycoprotein (a protein that moves substances across the blood‑brain barrier) will exclude you, unless those medicines can be safely stopped before the imaging.
If the tumor is extensively present on both sides of the brain (extensive bilateral tumor involvement), you cannot be included because the study needs separate regional analysis.

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UMCG
Verified
Groningen, The Netherlands

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Investigated drugs

[18F]MC225 is a radioactive tracer that is injected into a vein. It helps doctors see how well a protein called P‑glycoprotein works at the blood‑brain barrier during a PET scan. By looking at how the tracer moves into and out of brain tissue, researchers can measure the barrier’s function in areas of a suspected glioblastoma and the surrounding tissue. This information is used to better understand the tumor’s behavior and may help guide treatment decisions.

[18F]Mc225

What is already known about the treatment

[18F]MC225 - [18F]MC225 is supplied as a sterile solution for injection and is given intravenously, usually at a dose of 400 MBq. It is an investigational radiopharmaceutical that is not yet approved for routine clinical use but appears in recent imaging research. The tracer is used to picture the activity of the P‑glycoprotein pump at the blood‑brain barrier, helping doctors study glioblastoma and nearby brain tissue. It works by carrying a tiny amount of radioactive fluorine‑18 that emits signals detected by a PET scanner, and it belongs to the class of PET imaging agents that target transport proteins.

Investigated diseases

Glioblastoma - Glioblastoma is a high‑grade malignant tumor that originates from astrocytic glial cells in the brain. It typically appears as a rapidly enlarging mass that enhances with contrast on MRI because of abnormal blood vessels. The tumor infiltrates surrounding brain tissue, leading to expansion of the lesion and formation of a surrounding area of swelling visible on T2/FLAIR images. Over time the lesion often develops necrotic regions and can spread within the brain, making complete removal difficult.