RecruitingNAINTERVENTIONAL

USPIO Enhanced MR Imaging in CNS Tumours (UMIC)

This research is looking at a new way to scan brain tumours using a special type of MRI. Many tumours, including those in the brain, have a lot of inflammatory cells called macrophages, which can affect how the tumour grows and responds to treatment. The study wants to find out if an iron-based dye, called ferumoxytol, can be seen on MRI scans after it’s taken up by these inflammatory cells. If successful, this could provide a new way to measure inflammation in brain tumours without needing a biopsy. The study is focusing on vestibular schwannomas and a type of glioma, aiming to understand how this imaging technique could help guide future treatments.

At a glance

Status

Recruiting

Phase

Sponsor

Northern Care Alliance NHS Foundation Trust

Enrolment target

Start

26 Apr 2024

Estimated completion

31 Dec 2026

Vestibular Schwannoma Glioma, Astrocytic

What is this study about?

This study, called UMIC, is carefully looking into whether a special kind of MRI scan can help us understand brain tumours better. We know that inflammation, which involves certain immune cells called macrophages, plays a big part in how many tumours grow and develop. These macrophages are often found in large numbers within brain tumours, and scientists believe they could be important for predicting how a tumour might behave and how it might respond to treatment.

The challenge is finding a practical way to see and measure these macrophages and inflammation inside the brain without needing surgery. This study explores if a modified MRI scan, using a special iron-based dye called ferumoxytol (brand name Feraheme), can do the job. When this dye is injected, it circulates in the blood and then gets absorbed by these inflammatory cells in the tumour. Once inside, the iron particles can be picked up by the MRI scanner, potentially showing where and how much inflammation is present.

This pilot study is specifically focusing on two types of brain tumours: vestibular schwannoma (both those that are stable and those that are growing) and a type of low-grade glioma that is showing signs of changing. For those patients who have surgery as part of their care, the study will compare the MRI scan results with actual tissue taken from the tumour. This will help researchers to understand exactly where the dye goes within the tumour cells, what kind of cells take it up, and how this relates to inflammation and the blood vessels in the tumour.

Key takeaways

This study uses a special MRI to look for inflammation in brain tumours.
It focuses on vestibular schwannomas and certain gliomas.
A special iron-based dye helps highlight inflammatory cells on the scan.
The goal is to find a new way to measure tumour inflammation without surgery.
Findings could improve future understanding and treatment strategies.
Participation involves several MRI scans over a few days.

Who may be eligible?

To be considered for this study, you need to be at least 16 years old and have a brain tumour that your doctor thinks is either a vestibular schwannoma or a low-grade glioma. You should also be able to lie comfortably still for about an hour during the MRI scan, and your doctor must believe you can comfortably complete all the study scans.

However, there are several reasons why someone might not be able to join. For example, if your doctor believes your life expectancy is less than a year, or if you've previously had radiation treatment for a brain tumour. Women who are pregnant or breastfeeding cannot participate. People with severe kidney problems, conditions where their body has too much iron, or certain immune conditions like lupus or rheumatoid arthritis are also excluded.

Additionally, if you have any medical devices that are not safe for an MRI, or if you experience severe anxiety or claustrophobia during MRI scans, you wouldn't be able to join. Lastly, if you've had allergic reactions to iron, dextran, or previous MRI dyes (gadolinium), or have asthma or kidney issues related to these, you wouldn't be suitable for the study. You also need to be able to understand information given in English.

Quick self-check

Am I at least 16 years old?
Do I have a vestibular schwannoma or a low-grade glioma?
Can I lie still for about an hour for an MRI scan?
Am I generally healthy enough to complete the scan schedule?
Have I had any previous brain radiation treatments?
Am I pregnant or breastfeeding?

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

What does participation involve?

If you decide to take part in this study, you will have several MRI scans. First, you'll have an MRI without the special dye. Then, you'll receive an injection of the ferumoxytol dye into your bloodstream. Following this, you'll have more MRI scans shortly after the injection (within 2 hours), and then again at 24 hours and 48 hours later. These scans will help the researchers track where the dye goes in your body and how it's taken up by the tumour. If you are having surgery for your tumour, the researchers will also look at the tumour tissue removed during the operation to compare it with your scan results. The total duration of your participation in terms of scans and assessments will involve these several visits over a few days.

Potential risks and benefits

Participating in this study might help improve our understanding of brain tumours and how inflammation affects them. This could potentially lead to better ways to monitor and treat these conditions in the future, although there's no direct benefit to you personally during the study itself. Potential risks include those associated with MRI scans, such as claustrophobia, and potential allergic reactions to the injected dye, although serious reactions are rare. The study dye, ferumoxytol, is an iron-based product, and some people might experience minor side effects like headache, dizziness, or nausea. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Salford Royal Hospital Northern Care Alliance NHS Foundation Trust
Salford, United Kingdom· Recruiting

Common questions

What is ferumoxytol?

Ferumoxytol is an iron-based dye that is injected into your bloodstream and helps certain types of cells, like inflammatory cells, show up more clearly on MRI scans.

Why is inflammation important in brain tumours?

Inflammation, caused by immune cells called macrophages, can affect how a brain tumour grows and how it responds to treatments. Understanding it better could lead to improved care.

Will this study change my current treatment?

No, this is a research study to gather information. It will not directly change your current medical treatment, but the findings could help develop new approaches in the future.

Are there any side effects from the dye?

While usually well-tolerated, some people might experience mild side effects like headache, dizziness, or nausea. Serious allergic reactions are very rare.

What happens if I stop participating?

You are free to leave the study at any time without needing a reason, and this will not affect the medical care you receive from your doctors.

How to find out more

Daniel Lewis, PhD MBBS

daniel.lewis-3@manchester.ac.uk +441612067050 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.