AuthorisedTherapeutic use (Phase IV)Interventional

Unravelling the invisiBle infiltRating cOmponeNT Of glioblaStomA Using mRi USpio (BRONTOSAURUS)

This study, called BRONTOSAURUS, is trying to find the best way to use a special dye called USPIO (which contains a tiny amount of iron) with MRI scans. The main goal is to figure out the right amount of USPIO to give people so that MRI scans of brain tumours, especially glioblastoma, become much clearer and easier for doctors to understand. First, six healthy volunteers will have MRI scans using different amounts of USPIO. A group of expert doctors will then look at these images to see which amount gives the best picture quality. After this, 15 patients with glioblastoma will have special MRI scans using this new method. The study aims to improve how we see these tumours, helping doctors make better decisions about treatment.

At a glance

Status

Authorised

Phase

Therapeutic use (Phase IV)

Sponsor

Stichting Radboud universitair medisch centrum

Enrolment target

Start

02 Dec 2024

Glioblastoma

What is this study about?

Imagine doctors are trying to see a very faint picture, and they need to make it much sharper and clearer. That's a bit like what this study is trying to do with MRI scans for a type of brain cancer called glioblastoma. This cancer can be difficult to see clearly on standard scans, which means doctors sometimes struggle to understand its full extent or how it’s behaving.

Researchers are using a special substance called USPIO, which is a tiny iron-based dye. When this dye is put into the body, it can help parts of the brain tumour stand out more clearly on an MRI scan. The main purpose of this study is to find the perfect amount of this dye to use to get the best possible pictures. Too little, and it might not help; too much, and it might not be ideal either. They want to find that 'sweet spot' that makes the images most useful for doctors.

Once they figure out the best amount of the dye, they will then use it to take detailed MRI scans of patients who have glioblastoma. The hope is that these new, super-clear images will give doctors a much better understanding of the tumour. This improved imaging could lead to more accurate diagnoses and help doctors plan better treatments for people with glioblastoma in the future.

Key takeaways

The study aims to improve how glioblastoma brain tumours are seen on MRI scans.
It uses a special iron-based dye called USPIO to make tumours clearer.
First, healthy volunteers help find the best amount of dye to use.
Then, glioblastoma patients will receive detailed scans with this new method.
The goal is to provide doctors with clearer images for better diagnoses and treatment planning.

Who may be eligible?

To start, this study needs a few healthy people to help figure out the best way to use the special dye for MRI scans. If you're a healthy adult, 18 years or older, you might be able to help with this first part of the study.

After that, the study will involve people who have been diagnosed with glioblastoma, a type of brain tumour. Again, you would need to be 18 years or older. The doctors running the study will look at your individual health to make sure this study is safe and right for you.

Whether you're healthy or have glioblastoma, your doctor will discuss all the details with you to see if you meet all the necessary requirements to take part in this research. They will make sure it's the right fit for your health and situation.

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.

Am I 18 years old or older?
Am I generally healthy (for the first part of the study)?
Have I been diagnosed with glioblastoma (for the second part of the study)?
Am I comfortable having injections and multiple MRI scans?
Am I able to lie still for the duration of an MRI scan?

Answer every question to see your result.

What does participation involve?

If you take part in this study, you will first have an initial health check-up to make sure you're suitable. During the study, you'll receive a small amount of the special iron-based dye called USPIO, which is given into a vein, similar to how blood is taken. You will then have several MRI scans. An MRI scan involves lying still in a large machine that uses strong magnets and radio waves to create detailed pictures inside your body. The entire process, including the dye administration and scans, will be spread over a few visits. For patients with glioblastoma, these scans will involve a new, detailed scanning method. The study does not mention specific follow-up visits beyond the imaging sessions, and the total duration would depend on the number of scans needed for each participant, but it is expected to be relatively short-term, focusing on the imaging process itself.

Potential risks and benefits

Taking part in this study may offer a potential benefit by helping doctors better understand glioblastoma, which could lead to improved diagnosis and treatment for others in the future. For the participants with glioblastoma, the detailed scans might provide more information about their own tumour, though this is not the main goal. As with any medical procedure, there are potential risks, mainly related to the MRI scan itself (like feeling uncomfortable in the scanner) and the USPIO dye, which could cause mild reactions in some people, though serious side effects are very rare. You will be closely monitored. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your 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
Netherlands

Common questions

What is glioblastoma?

Glioblastoma is a serious type of brain tumour that grows quite quickly. This study aims to help doctors see these tumours more clearly.

What is USPIO?

USPIO is a special dye that contains tiny amounts of iron. It's given through a vein and helps parts of the body, like tumours, show up better on MRI scans.

Will I feel anything from the USPIO dye?

Most people don't feel much from the USPIO dye. Occasionally, some people might have a mild reaction, but you will be monitored closely by medical staff.

What is an MRI scan like?

An MRI scan involves lying still on a table that slides into a large, tube-shaped machine. It uses magnets and radio waves to take detailed pictures inside your body and can be a bit noisy.

Will taking part benefit me directly?

While the primary goal is to help future patients, the insights gained might indirectly benefit your own care. For healthy volunteers, there is no direct personal health benefit.