Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

Comparison of 18F-Fluciclovine PET versus 18F-Fluoroethyltyrosine PET in patients with newly diagnosed cerebral gliomas, recurrent cerebral gliomas and brain metastases – an open label single centre single arm prospective basket trial

This study is looking at two different types of advanced body scans, called PET scans, for people who have been diagnosed with brain tumours. The main goal is to compare how well these two scans, known as Axumin and FET, can show the size and spread of brain tumours. This includes new tumours, tumours that have come back, and tumours that have spread to the brain from other parts of the body. Imagine doctors want to measure a tumour. This study is like trying out two different rulers to see if they both give the same, accurate measurement. By comparing these scans, researchers hope to understand if Axumin could be a good tool for doctors to use to help plan treatment and monitor these conditions in the future.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Universitaetsklinikum Aachen AöR

Enrolment target

Start

11 Mar 2024

Patients with newly diagnosed cerebral gliomas recurrent cerebral gliomas and brain metastases.

What is this study about?

This study is designed to help doctors get a clearer picture of brain tumours in patients. When someone has a brain tumour, whether it's newly found, has returned, or has spread from another part of the body, doctors need to understand its size and where it's located to plan the best treatment. Currently, there are different ways to do this, and this study is focusing on comparing two special types of scans called PET scans.

Think of these PET scans as very advanced cameras that can see certain activities inside your body. The two scans being compared are called Axumin and FET. Researchers want to see if these two scans show the same information about the tumour's size and how it's spread in a patient's brain. They will use a panel of experts to review the scan results and decide if both scans agree on what they see.

The main reason for doing this study is to find out if Axumin, which might offer some advantages, provides similar information to FET, which is already a known scan. If Axumin proves to be just as good, or even better, it could give doctors more options for carefully checking on brain tumours. This could lead to more accurate diagnoses and better treatment plans for patients in the future.

Key takeaways

This study compares two types of brain scans (Axumin and FET PET) for people with brain tumours.
The goal is to see if these scans give similar information about tumour size and spread.
It includes people with new, recurrent, or spread brain tumours.
If Axumin works well, it could offer doctors more options for diagnosing and monitoring.
Participation involves receiving two different PET scans.
You must be 18 years or older to participate.

Who may be eligible?

This study is looking for adult volunteers, meaning anyone aged 18 years or older. There is no upper age limit, so people of all adult ages can take part.

This study includes both men and women. Your sex does not affect whether you can participate.

To be considered for this study, you must have one of the following conditions: a brain tumour that has been newly diagnosed, a brain tumour that has returned after treatment, or a brain tumour that has spread to your brain from cancer elsewhere in your body.

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 new brain tumour?
Has your brain tumour come back?
Has cancer spread to your brain from another part of your body?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would have two different types of PET scans: one with Axumin and one with FET. These are special scans where you would receive a small, safe injection of a tracer substance before each scan to help the pictures show up clearly. The researchers will be comparing the results of these two scans to see how well they measure and show your brain tumour. You will attend a single centre for these scans and the study will not involve any additional medications or long-term follow-up beyond the scans themselves and necessary medical evaluations related to them. The total duration of your participation would be for the period required to complete these scans and assessments.

Potential risks and benefits

Taking part in this study may not directly benefit you, but the information gained could help other patients with similar conditions in the future by improving how doctors assess brain tumours. As with any medical procedure, there are some potential risks associated with the PET scans, such as a small exposure to radiation (similar to an X-ray) and possible mild reactions at the injection site. All procedures will be explained in detail, and your safety is the highest priority. Remember, participating is completely voluntary, and you have the right to withdraw from the study at any time without giving a reason, and this will not affect your routine medical care.

Locations (1)

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

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Unverified
Germany

Common questions

What is a PET scan?

A PET scan is a special imaging test that helps doctors see how your organs and tissues are working. It uses a small amount of a radioactive tracer that you receive through an injection, which then highlights areas of activity in your body.

What's the difference between Axumin and FET?

Both Axumin and FET are simply different types of tracers used in a PET scan. This study is comparing them to see if they both give similar, useful information about brain tumours.

Will I get any treatment in this study?

No, this study is not about new treatments. It's about comparing two different diagnostic scans to improve how doctors see and understand brain tumours, which can then help them plan future treatments.

How long will my involvement in the study be?

Your involvement typically involves a few visits for the scans and related assessments. It's not a long-term study that requires ongoing follow-up for years.

Could this study help me personally?

While the main goal is to improve understanding for future patients, the scans you receive might provide additional information that your doctor can use as part of your overall care.