AuthorisedPhase I and Phase II (Integrated)- OtherInterventional

uPAR PET/MRI in glioma

This research trial is open to adults with a brain tumour called glioma. We are testing a new scanning method called uPAR-PET/MRI. This scan uses a small amount of a special substance, called [68Ga]NOTA-AE105, which helps us see a protein called uPAR in the tumour. By comparing the scan images with lab tests of tumour tissue, we want to see if this new scan can accurately show how much uPAR is present. We also want to find out if the amount of uPAR seen on the scan can help predict how the tumour might behave over time, looking at things like how long patients live and how long it takes for the tumour to grow or return. Participants will have this scan and then be followed for up to 36 months.

At a glance

Status

Authorised

Phase

Phase I and Phase II (Integrated)- Other

Sponsor

Rigshospitalet

Enrolment target

Start

29 Jan 2025

Glioma

What is this study about?

This study is for adults who have a type of brain tumour called glioma. Gliomas can be difficult to treat, and doctors are always looking for better ways to understand and monitor them. This trial is exploring a new way to get more information about these tumours using a special type of scan called a uPAR-PET/MRI.

The scan uses a tiny amount of a harmless substance called [68Ga]NOTA-AE105 (you might hear it called a 'tracer'). This tracer is designed to temporarily attach itself to a specific protein called uPAR, which can sometimes be found in higher amounts on cancer cells. By seeing where the tracer goes, the scan can help doctors understand how much uPAR is in the tumour. The main goal is to check if the new scan can accurately show how much uPAR is in the tumour by comparing the scan results with samples of tumour tissue that have been looked at under a microscope.

Beyond simply detecting uPAR, we also want to learn if the amount of uPAR found by the scan can give us clues about how the tumour might behave. This means we'll be carefully following participants for up to three years after their scan to see if the uPAR levels are linked to how long people live or how long it takes before the tumour grows or comes back. We hope that this research will eventually lead to better ways to diagnose, monitor, and treat gliomas in the future.

Key takeaways

This study uses a special scan (uPAR-PET/MRI) for people with glioma.
It aims to see if the scan can accurately measure a protein called uPAR in tumours.
Researchers want to know if uPAR levels can help predict how the tumour might behave.
The study involves one scan and then follow-up appointments for three years.
It does not involve new treatments, only an imaging technique.

Who may be eligible?

To join this study, you must be an adult aged 18 or over. The study is open to both men and women.

You would need to have been diagnosed with a brain tumour called glioma to be considered for this trial.

There might be other health requirements or circumstances that mean you can or cannot take part, so a doctor or research nurse will carefully check if this study is right for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Have you been diagnosed with a glioma (a type of brain tumour)?
Are you able to attend follow-up appointments for up to three years?
Are you comfortable with having a special scan and a small injection?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, the main part will involve having a special scan called a uPAR-PET/MRI. This scan happens within about an hour after you receive a small injection of the special tracer ([68Ga]NOTA-AE105). You will then have follow-up appointments over a period of 36 months (three years) after your scan. During these follow-up visits, doctors will check on your health and the progress of your condition. You will not receive any new or experimental medications as part of this study; it's focused on the scan and its results.

Potential risks and benefits

Taking part in a trial might offer the potential benefit of closer monitoring of your condition. While this specific trial does not test a new treatment, the information learned might help improve future care for people with glioma. As with any medical procedure, there are potential risks, though these will be explained in detail by the study team. For example, there might be slight discomfort from the injection or a very small exposure to radiation from the scan, as is normal with PET scans. You are completely free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

—
Unverified
Denmark

Common questions

What is a glioma?

A glioma is a common type of brain tumour that starts in the brain or spinal cord.

What is uPAR?

uPAR is a protein that can be found in some cancer cells, and doctors are studying it to understand its role in tumours.

Will I get a new treatment in this study?

No, this study is about a new type of scan to gather information about your tumour, not about testing a new treatment.

How long will I be involved in the study?

After your scan, you will be followed up by the study team for about three years (36 months).

Is the injection safe?

The substance injected ([68Ga]NOTA-AE105) is given in a very small amount and is designed to be safe, with any potential risks explained by the medical team.